Clinician Reviews

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

Maternal vaccination with two doses of the mRNA COVID-19 vaccine was 95% effective against infant infection from the delta variant, and 45% effective against infant infection from the omicron variant, a new study shows.

Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.

In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.

Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.

Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.

The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.

The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).

Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.

The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.

The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.

The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).

Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.

Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.

The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.

Effectiveness is encouraging, but updates are needed

The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.

They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.

Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.

The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.

Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.

“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.

*This article was updated on 3/2/2023.

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Men and women aged 35 and older with severe obesity who had bariatric surgery had improved survival up to 4 decades afterward compared with individuals of the same age, sex, and body mass index who did not undergo surgery.

Death from cardiovascular disease, cancer, and diabetes was 29%, 43%, and 72% lower, respectively, in the bariatric surgery patients versus nonsurgery peers, during a mean follow-up of 13 years (all P > .001).

However, the youngest group of bariatric surgery patients – who were 18-34 years old – had a fivefold increased risk of suicide during follow-up compared with their peers who did not undergo surgery (P = .001).  

These findings are from a retrospective study in Utah that matched close to 22,000 patients with severe obesity who underwent Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch from 1982 to 2018 with an equal number of nonsurgery individuals.  

The study, by Ted D. Adams, PhD, MPH, and colleagues, was published online in Obesity.
 

‘Impressive’ data, in men too, but psychological screening important 

The overall improved survival and decreased deaths from diabetes, heart disease, and cancer over this long follow-up are “impressive,” Dr. Adams, of Intermountain Surgical Specialties/Digestive Health Clinical Program, Salt Lake City, said in an interview.

Previous studies have not shown a survival benefit from bariatric surgery versus no surgery in men, he said. However, “because we had a fair number of male patients and because of the length of follow-up, we did show that the improved mortality was not only evident for the female patients but also for the male patients,” Dr. Adams stressed.

Finding increased suicide rates among bariatric surgical patients who underwent surgery at a younger age (18-34 years) shows that “we need to try and determine who is at risk for suicide,” according to Dr. Adams.  

Patients with severe obesity, especially younger ones, “may need more aggressive presurgical psychological screening and postsurgery follow-up,” wrote Dr. Adams and colleagues.

The findings may also “stimulate important research related to the discovery of physiologic and biomolecular mechanisms leading to nonsurgical treatment that results in weight loss and improved mortality similar to that achieved by bariatric surgery,” they suggested. 
 

Close to 1 in 10 Americans has severe obesity

The prevalence of severe obesity (BMI ≥ 40 kg/m²) in the United States has increased from 4.7% during 1999-2000 to 9.2% during 2017-2018, based on National Health and Nutrition Examination Survey (NHANES) data, the researchers noted.

They previously published a study of long-term mortality in 7,925 patients who had gastric bypass surgery from 1984 to 2002 matched with patients with the same BMI who did not have bariatric surgery and were followed out to 2002.

The current study extends the follow-up through 2021, doubles the number of bypass patients, and includes three newer types of bariatric surgery.  

The researchers matched 21,873 patients aged 18-80 who had Roux-en-Y gastric bypass, gastric banding, sleeve gastrectomy, or duodenal switch during 1982-2018 in Utah (from the Utah Population Database) with people of the same BMI category, age category (18-34, 35-44, 45-54, and 55-80 years), and sex (from Utah driver license data).

Most patients were women (79%) and most were White (94% and 85%). They had a mean age of 42 years and a mean BMI of 46 kg/m².

Most patients had Roux-en-Y gastric bypass (69%), and the rest had sleeve gastrectomy (14%), gastric banding (12%), and duodenal switch (4.8%).

During follow-up, 13.5% of patients in the bariatric surgery group and 14.6% of people in the nonsurgery group died.

Overall, all-cause mortality was 16% lower in patients who had bariatric surgery versus matched nonsurgical participants; it was 14% lower in women and 21% lower in men (all P < .001).

All-cause mortality was significantly lower in patients who had bariatric surgery when they were 35-44, 45-54, and 55-80 years old compared with matched peers who did not have surgery.

However, the findings “should not imply patients necessarily postpone surgery until older age,” the researchers cautioned, “as postsurgical complications have been shown to increase with increasing age at surgery and surgical postponement may result in worsened clinical status related to certain conditions such as orthopedic joint health.”

The researchers found significantly improved all-cause mortality following either type of surgery (gastric bypass, gastric banding, and sleeve gastrectomy) compared with no surgery.

Along with fewer deaths from cardiovascular disease, cancer, and diabetes, deaths from lung disease were 39% lower in the surgery group than in the nonsurgery group.

However, in the youngest group (age 18-34), deaths from cirrhosis of the liver were significantly higher in the patients who had bariatric surgery, and rates of suicide were significantly greater for both females and males, compared with similar people who did not undergo surgery.  

The study was supported by grants from Ethicon Endo-Surgery (Johnson & Johnson); the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health; U.S. Public Health Service; and Intermountain Research and Medical Foundation of Intermountain Healthcare. Dr. Adams disclosed ties to Ethicon Endo-Surgery and Intermountain Healthcare. A coauthor reported ties with Biomedical Research Program at Weill Cornell Medicine in Qatar, a program funded by the Qatar Foundation. The other authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Gout-associated genetic factors increase the risk of gout by nearly two and a half times among people with a close family history of the disease. The risk is approximately three times higher among people with a family history of gout who are also heavy drinkers; for people with a family history of gout who are also overweight, the risk is four times higher, according to a large population-based study from South Korea.

The increased familial risk of gout (hazard ratio, 2.42) dropped only slightly after adjustment for lifestyle and biological risk factors (HR, 2.29), suggesting that genes are the key drivers for the risk of gout among first-degree relatives.

Robert Kirk/iStock/Getty Images Plus

Risk was highest among individuals with an affected brother (HR, 3.00), followed by father (HR, 2.33), sister (HR, 1.97), and mother (HR, 1.68).

“Although the familial aggregation of gout [where a first-degree relative has the disease] is influenced by both genetic and lifestyle/biological factors, our findings suggest that a genetic predisposition is the predominant driver of familial aggregation,” first author Kyoung-Hoon Kim, PhD, from Health Insurance Review and Assessment Service, Wonju-si, South Korea, and colleagues wrote in Arthritis Care and Research.

However, lifestyle is still important, as suggested by comparisons with members of the general population who do not have a family history of gout or a high body mass index (BMI). The risk increased for persons with a family history of gout who were also overweight (HR, 4.39), and it increased further for people with obesity (HR, 6.62), suggesting a dose-response interaction, the authors wrote.

When family history was combined with heavy alcohol consumption, the risk rose (HR, 2.95) in comparison with the general population who had neither risk factor.

The study fills a gap in evidence on “familial risk of gout as opposed to hereditary risk of gout, which has long been recognized,” the researchers wrote.

In addition, the findings suggest the possibility of a dose-dependent gene-environment interaction, “as the combination of both a family history of gout and either high BMI or heavy alcohol consumption was associated with a markedly increased risk of disease, which was even further elevated among obese individuals.”

Abhishek Abhishek, MD, professor of rheumatology and honorary consultant rheumatologist at Nottingham (England) University Hospitals NHS Trust, reflected on the minimal attenuation after adjustment for lifestyle and demographic factors. “This suggests that most of the familial impact is, in fact, genetic rather than due to shared environmental factors and is an important finding.”

He said in an interview that the findings also confirmed the synergistic effect of genetic and lifestyle factors in causing gout. “Lifestyle factors such as alcohol excess and obesity should be addressed more aggressively in those with a first-degree relative with gout.

“Although not directly evaluated in this study, aggressive management of excess weight and high alcohol consumption may prevent the onset of gout or improve its outcomes in those who already have this condition,” he added.
 

Study of over 5 million individuals with familial aggregation of gout

The researchers drew on data from the government-operated mandatory insurance service that provides for South Korea’s entire population of over 50 million people (the National Health Insurance database), as well as the National Health Screening Program database. Information on familial relationships and risk factor data were identified for 5,524,403 individuals from 2002 to 2018 who had a blood-related first-degree relative.

Familial risk was calculated by comparing the risk of individuals with and those without affected first-degree relatives. Interactions between family history and obesity or alcohol consumption were assessed using a scale that measured gout risk due to interaction of two factors.

Initially, adjustments to familial risk were made with respect to age and sex. Subsequently, possible risk factors included smoking, BMI, hypertension, and hyperglycemia.

Alcohol consumption levels were noted and categorized as nondrinker, moderate drinker, or heavy drinker, with different consumption levels for men and women. For men, heavy drinking was defined as having at least two drinks per week and at least five drinks on any day; for women, heavy drinking was defined as having at least two drinks per week and at least four drinks on any day.

Overweight and obesity were determined on the basis of BMI, using standard categories: overweight was defined as BMI of 25 to less than 30 kg/m2, and obesity was defined as BMI of 30 or higher.

Dr. Kim and coauthors noted that both high BMI and heavy drinking were associated with an increased risk of gout, regardless of whether there was a family history of the disease, and that the findings suggest “a dose-dependent interactive relationship in which genetic factors and obesity potentiate each other rather than operating independently.”

People who are both overweight and have a family history of disease had a combined risk of gout that was significantly higher than the sum of their individual risk factors (HR, 4.39 vs. 3.43). This risk was accentuated among people with obesity (HR, 6.62 vs. 4.74) and was more pronounced in men than in women.

In other risk analyses in which familial and nonfamilial gout risk groups were compared, the risk associated with obesity was higher in the familial, compared with the nonfamilial group (HR, 5.50 vs. 5.36).

Bruce Rothschild, MD, a rheumatologist with Indiana University Health, Muncie, and research associate at Carnegie Museum of Natural History, Pittsburgh, shared his thoughts on the study in an interview and noted some limitations. “The findings of this study do not conflict with what is generally believed, but there are several issues that complicate interpretation,” he began. “The first is how gout is diagnosed. Since crystal presence confirmation is rare in clinical practice, and by assumption of the database used, diagnosis is based on fulfillment of a certain number of criteria, one of which is hyperuricemia – this is not actual confirmation of diagnosis.”

He pointed out that the incidence of gout depends on who received treatment, and the study excluded those who were not receiving treatment and those who were not prescribed allopurinol or febuxostat. “Single parents were also excluded, and this may also have affected results.

“Overweight and obesity were not adjusted for age, and the interpretation is age dependent,” he added. “It really comes down to the way gout is diagnosed, and this is a worldwide problem because the diagnosis has been so dumbed down that we don’t really know what is claimed as gout.”

Dr. Kim and coauthors disclosed no relevant financial relationships. Dr. Abhishek has received institutional research grants from AstraZeneca and Oxford Immunotech and personal fees from UpToDate, Springer, Cadilla Pharmaceuticals, NGM Bio, Limbic, and Inflazome. Dr. Rothschild disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

A version of this article first appeared on Medscape.com.

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

A version of this article first appeared on Medscape.com.

Among adults hospitalized for COVID-19, acute cardiac events are common, particularly among those with underlying heart disease, and are associated with more severe disease outcomes, a new study suggests.

“We expected to see acute cardiac events occurring among adults hospitalized with COVID-19 but were surprised by how frequently they occurred,” Rebecca C. Woodruff, PhD, MPH, of the U.S. Centers for Disease Control and Prevention, Atlanta, told this news organization.

Overall, she said, “about 1 in 10 adults experienced an acute cardiac event – including heart attacks and acute heart failure – while hospitalized with COVID-19, and this included people with no preexisting heart disease.”

However, she added, “about a quarter of those with underlying heart disease had an acute cardiac event. These patients tended to experience more severe disease outcomes relative to patients hospitalized with COVID-19 who did not experience an acute cardiac event.”

The findings might be relevant to hospitalizations for other viral diseases, “though we can’t say for sure,” she noted. “This study was modeled off a previous study conducted before the COVID-19 pandemic among adults hospitalized with influenza. About 11.7% of [those] adults experienced an acute cardiac event, which was a similar percentage as what we found among patients hospitalized with COVID-19.”

The study was published online in the Journal of the American College of Cardiology.
 

Underlying cardiac disease key

Dr. Woodruff and colleagues analyzed medical records on a probability sample of 8,460 adults hospitalized with SARS-CoV-2 infection identified from 99 U.S. counties in 14 U.S. states (about 10% of the United States population) from January to November 2021.

Among participants, 11.4% had an acute cardiac event during their hospitalization. The median age was 69 years; 56.5% were men; 48.7%, non-Hispanic White; 33.6%, non-Hispanic Black; 7.4%, Hispanic; and 7.1%, non-Hispanic Asian or Pacific Islander.

As indicated, the prevalence was higher among those with underlying cardiac disease (23.4%), compared with those without (6.2%).

Acute ischemic heart disease (5.5%) and acute heart failure (5.4%) were the most prevalent events; 0.3% of participants had acute myocarditis or pericarditis.

Risk factors varied, depending on underlying cardiac disease status. Those who experienced one or more acute cardiac events had a greater risk for intensive care unit admission (adjusted risk ratio,1.9) and in-hospital death (aRR, 1.7) versus those who did not.

In multivariable analyses, the risk of experiencing acute heart failure was significantly greater among men (aRR, 1.5) and among those with a history of congestive heart failure (aRR, 13.5), atrial fibrillation (aRR, 1.6) or hypertension (aRR,1.3).

Among patients who experienced one or more acute cardiac events, 39.2% required an intensive care unit stay for a median of 5 days. Approximately 22.4% required invasive mechanical ventilation or extracorporeal membrane oxygenation, and 21.1% died while hospitalized.

“Persons at greater risk for experiencing acute cardiac events during COVID-19–associated hospitalizations might benefit from more intensive clinical evaluation and monitoring during hospitalization,” the authors conclude.

The team currently is taking a closer look at acute myocarditis among patients hospitalized with COVID-19, Dr. Woodruff said. Preliminary results were presented at the 2022 annual scientific sessions of the American Heart Association and a paper is forthcoming.
 

Contemporary data needed

James A. de Lemos, MD, co-chair of the American Heart Association’s COVID-19 CVD Registry Steering Committee and professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said the findings mirror his team’s clinical experience in 2020 and 2021 and echo what was seen in the AHA COVID registry: that is, a 0.3% rate of myocarditis.

“The major caveat is that [the findings] may not be generalizable to contemporary COVID infection, both due to changing viral variants and higher levels of immunity in the population,” he said.

“Rates of COVID hospitalization are markedly lower with the current dominant variants, and we would expect the cardiac risk to be lower as well. I would like to see more contemporary data with current variants, particularly focused on higher risk patients with cardiovascular disease,” Dr. de Lemos added.

In a related editorial, George A. Mensa, MD, of the National Heart, Lung, and Blood Institute in Bethesda, Md., and colleagues suggest that the broader impact of the COVID-19 pandemic on human health remains “incompletely examined.”

“The impact of COVID-19 on cardiovascular mortality, in particular, appears to have varied widely, with no large increases seen in a number of the most developed countries but marked increases in hypertensive heart disease mortality seen in the United States in 2021,” they conclude. “The potential contribution of COVID-19 to these deaths, either directly or indirectly, remains to be determined.”

No commercial funding or relevant financial relationships were reported.

A version of this article first appeared on Medscape.com.

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.

One year ago, as the sun was setting on a late fall day, Andrés Snitcofsky, a 40-year-old designer from Buenos Aires, Argentina, heard harrowing cries for help. It was the niece and the wife of one of his neighbors: a man in his 60s who the women had found “passed out” in the bedroom. While they were all waiting for the ambulance, Mr. Snitcofsky went over, tilted the man’s head back, and confirmed that he wasn’t breathing, that he wasn’t choking. And then he started chest compressions, just like he’d learned in a CPR class he’d taken 2 decades earlier. “I did CPR for 5 minutes straight until a friend of the victim came in and asked me to stop, telling me that the man had probably been dead for 2 or 3 hours already. But I had no idea because I’d never seen a dead body before,” Mr. Snitcofsky told this news organization. A few minutes later, the ambulance arrived. The doctor confirmed that there was nothing more that could be done.

Mr. Snitcofsky went home. Nobody had asked for his name or address or phone number. … And it wasn’t because they already knew who he was. In fact, there wasn’t any sort of relationship there. Mr. Snitcofsky had only known his neighbors by sight. His actions that day, however, “did not come without a cost. It took me weeks – months, actually – to put myself together again,” he said. The things he saw, the things he heard, everything about that night played over and over in his head. “I had trouble sleeping. I would play out different scenarios in my head. I questioned myself. I second-guessed myself, criticized myself. It’s like some taboo subject. There’s no one to share the experience with, no one who gets it. But with time, I was able to process the event.

“For 2 months, I talked to my psychologist about it all,” he continued. “That really helped me a lot. In addition to therapy, I reached out to a couple I know – they’re both physicians – and to a firefighter who teaches CPR. Their insight and guidance allowed me to get to a point where I was able to understand that what I did was a good thing and that what I did was all that could have been done. But anyone who finds themselves in the position of having to do CPR – they’re going to be affected in many, many ways. It goes beyond the euphoria of seeing a person come back to life. Of that, I’m quite certain.”

We’ve all seen campaigns encouraging people to learn CPR and to be prepared if the need arises. But in training the public (and even health care professionals), not much, if anything, is said about the “collateral damage”: the psychological and emotional consequences of carrying out the procedure. These especially come into play when you don’t know whether the person survived, when your efforts weren’t able to reverse the sudden cardiac arrest, or when the person you gave CPR to was a loved one – a case that may entail immediate therapeutic interventions to minimize or prevent the risk of suffering long-lasting trauma.

In May 2020, popular American activist and educator Kristin Flanary saw someone suffering cardiac arrest. She stepped in and started doing CPR. And she continued doing CPR … for 10 long minutes. The person she was trying to save was her 34-year-old husband, ophthalmologist and comedian Will Flanary. On Twitter, where she’s known as Lady Glaucomflecken, Ms. Flanary recently shared the following message, putting the topic of CPR and automated external defibrillator training front and center.

“Yes, everyone should learn #CPRandAED. But if we are going to ask people to perform such a brutal task, it’s imperative that we also provide them with the info and resources they need to process it mentally and emotionally. It’s traumatic and life changing. It’s irresponsible and unethical to ask people to help in such a brutal and traumatic way and then neglect to help them in return.” In less than a month, the tweet has racked up over 200,000 views.
 

Doing one’s duty

There are many people who work to promote CPR and strengthen the other links in the chain of survival for out-of-hospital sudden cardiac arrest, such as prompt access to and delivery of early defibrillation. According to them, any negative psychological impact of intervening is temporary and, when compared with the satisfaction of having done one’s duty, quite insignificant – even if the efforts to save a person’s life are not successful.

“In 99.9% of cases, people who have performed CPR feel a sense of satisfaction, even happiness, knowing that they’ve helped. The individuals I’ve spoken with, I’ve never heard any of them say that they felt worse after the event or that they needed to see a psychologist,” said Mario Fitz Maurice, MD, director of the Arrhythmia Council of the Argentine Society of Cardiology and head of Electrophysiology at Rivadavia Hospital in Buenos Aires. He went on to tell this news organization, “Of course, some degree of fear, sadness, or melancholy can remain afterward. But it seems to me, and there are reports saying as much, that, in the end, what stands out in the person’s mind is the fact that they tried to save a life. And for them, there’s joy in knowing this.”

Dr. Fitz Maurice, who is also the director of the National Arrhythmia Institute in Buenos Aires, pointed out that the kind of person who takes CPR classes “has a profile that’s going to allow them to be psychologically involved; they’re the caring person, the one who’s ready and willing to help people.” And he added that, at his hospital, if they can identify the individuals or first responders who have done CPR on a patient, the protocol is to always contact them to offer psychological care and assistance. “But in 99% of cases, they don’t even understand why we’re calling them, they’re extremely happy to have taken part.”

Some studies, though, paint a much different picture, one that shows that providing CPR can be emotionally challenging and have consequences in terms of one’s family and work life. A qualitative study published in 2016 looked into the experiences of 20 lay rescuers in Norway – five were health educated – who had provided CPR to 18 out-of-hospital cardiac arrest (OHCA) victims, 66% of whom survived. The time from experiencing the OHCA incident to participating in the interview ranged from 6 days to 13 years (median 5.5 years). Several participants reported the OHCA incident as a “shocking and terrifying” experience. Tiredness, exhaustion, confusion, and feeling alone about the OHCA experience were individual reactions that could vary in time from days to months. Anxiety and insomnia were also experienced following the incident.

Some lay rescuers described the influence on work and family life, and a few of them described deep sorrow, even several years after the incident. Overall, they reported repetitive self-criticism regarding whether they could have carried out anything else to achieve a better outcome for the cardiac arrest victim. All of them wanted to be informed about the outcome. And four of the lay rescuers needed professional counseling to process the OHCA experience.

In 2020, another qualitative study was conducted, this time in Taiwan. There were nine participants, none of whom were health professionals. Each had provided initial CPR and defibrillation with AED in public locations. Event-to-interview duration was within 1 year and 1-2 years. The major findings from the study were the following:

• The lay rescuers possessed helping traits and high motivation.  
• The lay rescuers reported certain aspects of rescue reality that differed much from prior training and expectations, including difficulty in the depth of chest compression, and uncertainties in real emergency situations.
• The lay rescuers gained positive personal fulfillment in sharing their experience and receiving positive feedback from others, and were willing to help next time, although they experienced a short-term negative psychological impact from the event.
“Measures should be taken to increase [a] layperson’s confidence and situation awareness, to reduce training-reality discrepancy, and to build up a support system to avoid negative psychological effects.” This was the conclusion of the study team, which was led by Matthew Huei-Ming Ma, MD, PhD. A professor in the department of emergency medicine at National Taiwan University in Taipei, he is also on the board of directors of the Resuscitation Council of Asia.

Potential trauma

In recalling his experience, Mr. Snitcofsky said, “The hardest part of it all was the moment that I stopped giving CPR, that moment of letting go. This became the image that kept coming back to me, the traumatic moment I hadn’t thought about.”

Psychiatrist Daniel Mosca, MD, is the founder and former president of the Argentine Society of Trauma Psychology. He is also the coordinator of the human factors team at the City of Buenos Aires Emergency Medical Care System. “Any event has the potential to be traumatic, all the more so when it’s an event where you come face to face with death and uncertainty. But how a rescuer reacts will depend on their psychological makeup.” Of the individuals who were held for months or years in the jungle as hostages of the Revolutionary Armed Forces of Colombia, “only” half developed symptoms of posttraumatic stress disorder.

Dr. Mosca believes that a comment by Frank Ochberg, MD, speaks to this finding. “In many cases, peritraumatic symptoms are a normal person’s normal response to an abnormal situation.” For a lot of people who have found themselves having to perform CPR, the symptoms associated with the initial acute stress reaction will resolve on their own in 30-90 days. “But if this doesn’t happen, and those symptoms persist, psychotherapeutic or pharmacological intervention will be necessary,” he noted.

“In CPR classes, it would be good for the instructors to talk about the warning signs that people should look out for in themselves and their fellow rescuers. So, for example, insomnia, anxiety, a heightened state of alertness, feeling disconnected from reality,” Dr. Mosca told this news organization.

“Another thing that can help rescuers is letting them know what happened to the person they gave CPR to. This way, they can get closure,” suggested Manlio Márquez Murillo, MD, a cardiologist and electrophysiologist in Mexico. He is also the coordinator of the Alliance Against Sudden Cardiac Death at the Interamerican Society of Cardiology.

“Medical and nursing societies would have to develop a brief protocol or performance standard. The goal would be to ensure that rescuers are asked for their contact information and that someone gets in touch to debrief them and to offer them care. Next would come the treatment part, to resolve any remaining aftereffects,” said in an interview.

For example, a three-stage Lay Responder Support Model (LRSM) was developed and implemented as part of a lay responder support program established in 2014 by the Peel Regional Council in Ontario. The LRSM identifies and engages individuals who witnessed or participated directly or indirectly in an OHCA, inviting them to participate in a debriefing session facilitated by a trained practitioner. Held 24-48 hours post event, the debriefing allows lay responders to contextualize their reaction to the event. The conversation also serves as an opportunity for them to fully articulate their concerns, questions, and thoughts. The facilitator can communicate stress reduction techniques and address psychological first aid needs as they emerge. Approximately 1 week post event, a secondary follow-up occurs. If the lay responder communicates a continuing struggle with symptoms impacting and interfering with everyday life, the facilitator offers a coordinated or facilitated referral for mental health support.

In an article published in the Journal of Cardiac Failure. Ms. Flanary speaks about the three kinds of language that anyone who was either forced to or inspired to perform CPR can use to help process their trauma: words that explain what happened, words that name (eg, “forgotten patients”), and words that validate the experience and allow the person to articulate their feelings. The tools and technologies that organizations and health care professionals provide can help the healing process. Empathy and compassion, too, have a place.

But there are virtually no standardized and proactive initiatives of this kind in much of the world, including Latin America. So, most people who just happened to be in the right place at the right time find that they have to navigate the “after” part all on their own.
 

Other obstacles

Dr. Márquez Murillo finds it unfortunate that countries in the region have yet to enact “Good Samaritan” laws. If individuals render aid to someone suffering cardiac arrest, then these laws would ensure that they will not be held liable in any way. This is the case in Argentina and Uruguay. So, the fear of things turning into a legal matter may be holding people back from taking action; that fear could also create additional stress for those who end up stepping in to help.

Even with the legal safeguards, exceptional circumstances may arise where rescuers find themselves facing unexpected emotional challenges. In Argentina, Virginia Pérez Antonelli, the 17-year-old who tried in vain to save the life of Fernando Báez Sosa, had to testify at the trial of the eight defendants accused of brutally beating him in January 2020. The press, the public – the attention of an entire country – was focused on her. She had to respond to the defense attorneys who were able to ask whether she was sure that she performed the CPR maneuvers correctly. And a few weeks ago, a medical examiner hired by the defense suggested that “the CPR may have made the situation worse” for the victim. An indignant Dr. Fitz Maurice responded on Twitter: “CPR SAVES LIVES!! Let’s not let a CHEAP AND BASELESS argument destroy all the work that’s been done…!”

Of course, there are consequences that are beyond our control and others that can, in fact, be anticipated and planned for. Dr. Fitz Maurice brought up a preventive approach: Make CPR second nature, teach it in schools, help people overcome their fears. “Cardiac deaths are 200 times more frequent than deaths resulting from fires – and we practice fire drills a lot more than we practice CPR,” he told this news organization. In a society where there is widespread training on the procedure, where people regularly practice the technique, those who have had the experience of giving someone CPR will feel less alone, will be better understood by others.

“On the other hand, beyond the initial impact and the lack of a formal support system, the medium- and long-term outcome for those who acted is also psychologically and emotionally favorable,” said Jorge Bombau, MD, an obstetrician/gynecologist in Buenos Aires. After Dr. Bombau’s 14-year-old son Beltrán suddenly died during a school sports tournament, Dr. Bombau became a prominent advocate spreading the word about CPR.

“I don’t know anyone who regrets doing CPR,” he told this news organization. “There may be a brief period when the person feels distressed or depressed, when they have trouble sleeping. But it’s been proven that doing a good deed improves one’s mood. And what better deed is there than trying to save someone’s life? Whether their efforts were successful or in vain, that person has, at the end of the day, done something meaningful and worthwhile.”

Mr. Snitcofsky shares this sentiment. For several months now, he’s been feeling he’s “in a good place.” And he’s been actively promoting CPR on social media. As he recently posted on Twitter, “I’m here to retweet everything that has to do with getting us all to become familiar with how to do CPR and working up the courage to do it. The training takes no more than a few hours.

“I want to know that, if I ever have an out-of-hospital sudden cardiac arrest, there will be neighbors, friends, or family members around who know how to do CPR. Every person who knows how to do CPR can persuade others, and those of us who’ve had to do CPR in real life are even better candidates for persuading others. And if one day a person ends up needing CPR, I want to step in again and make up for lost time. Here’s hoping it’ll do the job,” he concluded.

It’s the same for Matías Alonso, a journalist in Buenos Aires. On New Year’s Eve 15 years ago, he was at a family dinner when, a few minutes before midnight, he found himself giving CPR to his stepmother’s father. “Unfortunately, he passed away, but I continued doing CPR on him until the ambulance arrived. For some time, I felt a little guilty for not taking charge of the situation from the beginning, and because I had this idea in my head that more people pulled through and recovered. But afterwards, they really thanked me a lot. And that helped me realize that I’d done something. I didn’t stand still when faced with the inevitability of death. I understood that it was good to have tried,” Mr. Alonso told this news organization. “And next time … hopefully there won’t be a next time … but I’m more prepared, and I now know how I can do better.”

Mr. Alonso, Mr. Snitcofsky, Dr. Fitz Maurice, Dr. Mosca, Dr. Bombau, and Dr. Márquez Murillo disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com. This article was translated from Medscape Spanish.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

Isotretinoin was not associated with a 1-year risk of incident inflammatory bowel disease (IBD) in a large population-based cohort study that also found no significant association of oral tetracycline-class antibiotics with IBD – and a small but statistically significant association of acne itself with the inflammatory disorders that make up IBD.

For the study, senior author John S. Barbieri, MD, MBA, of the department of dermatology, at Brigham and Women’s Hospital, Boston, and his colleagues used data from the TriNetX global research platform, which mines patient-level electronic medical record data from dozens of health care organizations, mainly in the United States. The network includes over 106 million patients. They looked at four cohorts: Patients without acne; those with acne but no current or prior use of systemic medications; those with acne managed with isotretinoin (and no prior use of oral tetracycline-class antibiotics); and those with acne managed with oral tetracycline-class antibiotics (and no exposure to isotretinoin).

Ocskay Bence/Fotolia.com

For the acne cohorts, the investigators captured first encounters with a diagnosis of acne and first prescriptions of interest. And studywide, they used propensity score matching to balance cohorts for age, sex, race, ethnicity, and combined oral contraceptive use.

“These data should provide more reassurance to patients and prescribers that isotretinoin does not appear to result in a meaningfully increased risk of inflammatory bowel disease,” they wrote in the study, published online in the Journal of the American Academy of Dermatology.

“These are important findings as isotretinoin is a valuable treatment for acne that can result in a durable remission of disease activity, prevent acne scarring, and reduce our overreliance on oral antibiotics for acne,” they added.

Indeed, dermatologist Jonathan S. Weiss, MD, who was not involved in the research and was asked to comment on the study, said that the findings “are reassuring given the large numbers of patients evaluated and treated.” The smallest cohort – the isotretinoin group – had over 11,000 patients, and the other cohorts had over 100,000 patients each, he said in an interview.

“At this point, I’m not sure we need any other immediate information to feel comfortable using isotretinoin with respect to a potential to cause IBD, but it would be nice to see some longitudinal follow-up data for longer-term reassurance,” added Dr. Weiss, who practices in Snellville, Georgia, and is on the board of the directors of the American Acne and Rosacea Society.

 

The findings: Risk with acne

To assess the potential association between acne and IBD, the researchers identified more than 350,000 patients with acne managed without systemic medications, and propensity score matched them with patients who did not have acne. Altogether, their mean age was 22; 32.1% were male, and 59.6% were White.

Compared with the controls who did not have acne, they found a statistically significant association between acne and risk of incident IBD (odds ratio, 1.42; 95% confidence interval, 1.23-1.65) and an absolute risk difference of .04%. Separated into Crohn’s disease (CD) and ulcerative colitis (UC), ORs were 1.56 and 1.62, respectively.
 

Tetracyclines

To assess the association of oral tetracycline use and IBD, they compared more than 144,000 patients whose acne was managed with antibiotics with patients whose acne was managed without systemic medications. The patients had a mean age of 24.4; 34.7% were male, and 68.2% were White.

Compared with the patients who were not on systemic medications, there were no significant associations among those on oral tetracyclines, with an OR for incident IBD of 1 (95% CI, 0.82-1.22), an OR for incident CD of 1.09 (95% CI, 0.86-1.38), and an OR for UC of 0.78 (95% CI, 0.61-1.00).
 

Isotretinoin

To evaluate the association of isotretinoin and IBD, the researchers compared more than 11,000 patients treated with isotretinoin with two matched groups: patients with acne managed without systemic medications, and patients with acne managed with oral tetracyclines. The latter comparison was made to minimize potential confounding by acne severity. These patients had a mean age of 21.1; 49.5% were male, and 75.3% were White.

In the first comparison, compared with patients not treated with systemic medications, the OR for 1-year incidence of IBD among patients treated with isotretinoin was 1.29 (95% CI, 0.64-2.59), with an absolute risk difference of .036%. The ORs for CD and UC were 1.00 (95% CI, 0.45-2.23) and 1.27 (95% CI, .58-2.80), respectively.

And compared with the antibiotic-managed group, the OR for incident IBD among those on isotretinoin was 1.13 (95% CI, 0.57-2.21), with an absolute risk difference of .018%. The OR for CD was 1.00 (95% CI, 0.45-2.23). The OR for UC could not be accurately estimated because of an insufficient number of events in the tetracycline-treated group.
 

‘Challenging’ area of research

Researching acne treatments and the potential risk of IBD has been a methodologically “challenging topic to study” because of possible confounding and surveillance bias depending on study designs, Dr. Barbieri, director of the Brigham and Women’s Advanced Acne Therapeutics Clinic, said in an interview.

Studies that have identified a potential association between isotretinoin and IBD often have not adequately controlled for prior antibiotic exposure, for instance. And other studies, including a retrospective cohort study also published recently in JAAD using the same TriNetX database, have found 6-month isotretinoin-related risks of IBD but no increased risk at 1 year or more of follow-up – a finding that suggests a role of surveillance bias, Dr. Barbieri said.

The follow-up period of 1 year in their new study was chosen to minimize the risk of such bias. “Since patients on isotretinoin are seen more often, and since there are historical concerns about isotretinoin and IBD, patients on isotretinoin may be more likely to be screened earlier and thus could be diagnosed sooner than those not on [the medication],” he said.

He and his coauthors considered similar potential bias in designing the no-acne cohort, choosing patients who had routine primary care visits without abnormal findings in order to “reduce potential for bias due to frequency of interaction with the health care system,” they noted in their paper. (Patients had no prior encounters for acne and no history of acne treatments.)
 

Antibiotics, acne itself

Research on antibiotic use for acne and risk of IBD is scant, and the few studies that have been published show conflicting findings, Dr. Barbieri noted. In the meantime, studies and meta-analyses in the general medical literature – not involving acne – have identified an association between lifetime oral antibiotic exposure and IBD, he said.

While the results of the new study “are reassuring that oral tetracycline-class exposure for acne may not be associated with a significant absolute risk of inflammatory bowel disease, given the potential for antibiotic resistance and other antibiotic-associated complications, it remains important to be judicious” with their use in acne management, he and his coauthors wrote in the study.

The potential association between antibiotics for acne and IBD needs further study, preferably with longer follow-up duration, Dr. Barbieri said in the interview, but researchers are challenged by the lack of datasets with high-quality longitudinal data “beyond a few years of follow-up.”

The extent to which acne itself is associated with IBD is another area ripe for more research. Thus far, it seems that IBD and acne – and other chronic inflammatory skin diseases such as psoriasis – involve similar pathogenic pathways. “We know that in IBD Th17 and TNF immunologic pathways are important, so it’s not surprising that there may be associations,” he said.

In their paper, Dr. Barbieri and his coauthors emphasize, however, that the absolute risk difference between acne and IBD is small. It’s “unlikely that population level screening is warranted among patients with acne,” they wrote.

A second new study

The other study, also published recently in JAAD, used the same TriNetX research platform to identify approximately 77,000 patients with acne starting isotretinoin and matched them with patients starting oral antibiotics.

The investigators, Khalaf Kridin MD, PhD, and Ralf J. Ludwig, MD, of the Lübeck Institute of Experimental Dermatology, University of Lübeck (Germany), found that the lifetime risks (greater than 6 months) for patients on isotretinoin were not significantly elevated, compared with those on oral antibiotics for either CD (hazard ratio 1.05; 95% CI, 0.89-1.24, P = .583) or UC (HR, 1.13; 95% CI, 0.95-1.34; P = .162) They also looked at the risk of irritable bowel syndrome (IBS) and found a lower lifetime risk in the isotretinoin group.

In the short term, during the first 6 months after drug initiation, there was a significant, but slight increase in UC in the isotretinoin group. But this risk decreased to the level of the antibiotic group with longer follow up. “The absolute incidence rates [of IBD] and the risk difference of UC within the first 6 months are of limited clinical significance,” they wrote.

It may be, Dr. Weiss said in commenting on this study, “that isotretinoin unmasks an already-existing genetic tendency to UC early on in the course of treatment, but that it does not truly cause an increased incidence of any type of IBD.”

Both studies, said Dr. Barbieri, “add to an extensive body of literature that supports that isotretinoin is not associated with IBD.”

Dr. Barbieri had no disclosures for the study, for which Matthew T. Taylor served as first author. Coauthor Shawn Kwatra, MD, disclosed that he is an advisory board member/consultant for numerous pharmaceutical companies and has served as an investigator for several. Both are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The other authors had no disclosures. Dr. Kridin and Dr. Ludwig had no disclosures for their study. Dr. Weiss had no disclosures.

Isotretinoin was not associated with a 1-year risk of incident inflammatory bowel disease (IBD) in a large population-based cohort study that also found no significant association of oral tetracycline-class antibiotics with IBD – and a small but statistically significant association of acne itself with the inflammatory disorders that make up IBD.

For the study, senior author John S. Barbieri, MD, MBA, of the department of dermatology, at Brigham and Women’s Hospital, Boston, and his colleagues used data from the TriNetX global research platform, which mines patient-level electronic medical record data from dozens of health care organizations, mainly in the United States. The network includes over 106 million patients. They looked at four cohorts: Patients without acne; those with acne but no current or prior use of systemic medications; those with acne managed with isotretinoin (and no prior use of oral tetracycline-class antibiotics); and those with acne managed with oral tetracycline-class antibiotics (and no exposure to isotretinoin).

Ocskay Bence/Fotolia.com

For the acne cohorts, the investigators captured first encounters with a diagnosis of acne and first prescriptions of interest. And studywide, they used propensity score matching to balance cohorts for age, sex, race, ethnicity, and combined oral contraceptive use.

“These data should provide more reassurance to patients and prescribers that isotretinoin does not appear to result in a meaningfully increased risk of inflammatory bowel disease,” they wrote in the study, published online in the Journal of the American Academy of Dermatology.

“These are important findings as isotretinoin is a valuable treatment for acne that can result in a durable remission of disease activity, prevent acne scarring, and reduce our overreliance on oral antibiotics for acne,” they added.

Indeed, dermatologist Jonathan S. Weiss, MD, who was not involved in the research and was asked to comment on the study, said that the findings “are reassuring given the large numbers of patients evaluated and treated.” The smallest cohort – the isotretinoin group – had over 11,000 patients, and the other cohorts had over 100,000 patients each, he said in an interview.

“At this point, I’m not sure we need any other immediate information to feel comfortable using isotretinoin with respect to a potential to cause IBD, but it would be nice to see some longitudinal follow-up data for longer-term reassurance,” added Dr. Weiss, who practices in Snellville, Georgia, and is on the board of the directors of the American Acne and Rosacea Society.

 

The findings: Risk with acne

To assess the potential association between acne and IBD, the researchers identified more than 350,000 patients with acne managed without systemic medications, and propensity score matched them with patients who did not have acne. Altogether, their mean age was 22; 32.1% were male, and 59.6% were White.

Compared with the controls who did not have acne, they found a statistically significant association between acne and risk of incident IBD (odds ratio, 1.42; 95% confidence interval, 1.23-1.65) and an absolute risk difference of .04%. Separated into Crohn’s disease (CD) and ulcerative colitis (UC), ORs were 1.56 and 1.62, respectively.
 

Tetracyclines

To assess the association of oral tetracycline use and IBD, they compared more than 144,000 patients whose acne was managed with antibiotics with patients whose acne was managed without systemic medications. The patients had a mean age of 24.4; 34.7% were male, and 68.2% were White.

Compared with the patients who were not on systemic medications, there were no significant associations among those on oral tetracyclines, with an OR for incident IBD of 1 (95% CI, 0.82-1.22), an OR for incident CD of 1.09 (95% CI, 0.86-1.38), and an OR for UC of 0.78 (95% CI, 0.61-1.00).
 

Isotretinoin

To evaluate the association of isotretinoin and IBD, the researchers compared more than 11,000 patients treated with isotretinoin with two matched groups: patients with acne managed without systemic medications, and patients with acne managed with oral tetracyclines. The latter comparison was made to minimize potential confounding by acne severity. These patients had a mean age of 21.1; 49.5% were male, and 75.3% were White.

In the first comparison, compared with patients not treated with systemic medications, the OR for 1-year incidence of IBD among patients treated with isotretinoin was 1.29 (95% CI, 0.64-2.59), with an absolute risk difference of .036%. The ORs for CD and UC were 1.00 (95% CI, 0.45-2.23) and 1.27 (95% CI, .58-2.80), respectively.

And compared with the antibiotic-managed group, the OR for incident IBD among those on isotretinoin was 1.13 (95% CI, 0.57-2.21), with an absolute risk difference of .018%. The OR for CD was 1.00 (95% CI, 0.45-2.23). The OR for UC could not be accurately estimated because of an insufficient number of events in the tetracycline-treated group.
 

‘Challenging’ area of research

Researching acne treatments and the potential risk of IBD has been a methodologically “challenging topic to study” because of possible confounding and surveillance bias depending on study designs, Dr. Barbieri, director of the Brigham and Women’s Advanced Acne Therapeutics Clinic, said in an interview.

Studies that have identified a potential association between isotretinoin and IBD often have not adequately controlled for prior antibiotic exposure, for instance. And other studies, including a retrospective cohort study also published recently in JAAD using the same TriNetX database, have found 6-month isotretinoin-related risks of IBD but no increased risk at 1 year or more of follow-up – a finding that suggests a role of surveillance bias, Dr. Barbieri said.

The follow-up period of 1 year in their new study was chosen to minimize the risk of such bias. “Since patients on isotretinoin are seen more often, and since there are historical concerns about isotretinoin and IBD, patients on isotretinoin may be more likely to be screened earlier and thus could be diagnosed sooner than those not on [the medication],” he said.

He and his coauthors considered similar potential bias in designing the no-acne cohort, choosing patients who had routine primary care visits without abnormal findings in order to “reduce potential for bias due to frequency of interaction with the health care system,” they noted in their paper. (Patients had no prior encounters for acne and no history of acne treatments.)
 

Antibiotics, acne itself

Research on antibiotic use for acne and risk of IBD is scant, and the few studies that have been published show conflicting findings, Dr. Barbieri noted. In the meantime, studies and meta-analyses in the general medical literature – not involving acne – have identified an association between lifetime oral antibiotic exposure and IBD, he said.

While the results of the new study “are reassuring that oral tetracycline-class exposure for acne may not be associated with a significant absolute risk of inflammatory bowel disease, given the potential for antibiotic resistance and other antibiotic-associated complications, it remains important to be judicious” with their use in acne management, he and his coauthors wrote in the study.

The potential association between antibiotics for acne and IBD needs further study, preferably with longer follow-up duration, Dr. Barbieri said in the interview, but researchers are challenged by the lack of datasets with high-quality longitudinal data “beyond a few years of follow-up.”

The extent to which acne itself is associated with IBD is another area ripe for more research. Thus far, it seems that IBD and acne – and other chronic inflammatory skin diseases such as psoriasis – involve similar pathogenic pathways. “We know that in IBD Th17 and TNF immunologic pathways are important, so it’s not surprising that there may be associations,” he said.

In their paper, Dr. Barbieri and his coauthors emphasize, however, that the absolute risk difference between acne and IBD is small. It’s “unlikely that population level screening is warranted among patients with acne,” they wrote.

A second new study

The other study, also published recently in JAAD, used the same TriNetX research platform to identify approximately 77,000 patients with acne starting isotretinoin and matched them with patients starting oral antibiotics.

The investigators, Khalaf Kridin MD, PhD, and Ralf J. Ludwig, MD, of the Lübeck Institute of Experimental Dermatology, University of Lübeck (Germany), found that the lifetime risks (greater than 6 months) for patients on isotretinoin were not significantly elevated, compared with those on oral antibiotics for either CD (hazard ratio 1.05; 95% CI, 0.89-1.24, P = .583) or UC (HR, 1.13; 95% CI, 0.95-1.34; P = .162) They also looked at the risk of irritable bowel syndrome (IBS) and found a lower lifetime risk in the isotretinoin group.

In the short term, during the first 6 months after drug initiation, there was a significant, but slight increase in UC in the isotretinoin group. But this risk decreased to the level of the antibiotic group with longer follow up. “The absolute incidence rates [of IBD] and the risk difference of UC within the first 6 months are of limited clinical significance,” they wrote.

It may be, Dr. Weiss said in commenting on this study, “that isotretinoin unmasks an already-existing genetic tendency to UC early on in the course of treatment, but that it does not truly cause an increased incidence of any type of IBD.”

Both studies, said Dr. Barbieri, “add to an extensive body of literature that supports that isotretinoin is not associated with IBD.”

Dr. Barbieri had no disclosures for the study, for which Matthew T. Taylor served as first author. Coauthor Shawn Kwatra, MD, disclosed that he is an advisory board member/consultant for numerous pharmaceutical companies and has served as an investigator for several. Both are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The other authors had no disclosures. Dr. Kridin and Dr. Ludwig had no disclosures for their study. Dr. Weiss had no disclosures.

Isotretinoin was not associated with a 1-year risk of incident inflammatory bowel disease (IBD) in a large population-based cohort study that also found no significant association of oral tetracycline-class antibiotics with IBD – and a small but statistically significant association of acne itself with the inflammatory disorders that make up IBD.

For the study, senior author John S. Barbieri, MD, MBA, of the department of dermatology, at Brigham and Women’s Hospital, Boston, and his colleagues used data from the TriNetX global research platform, which mines patient-level electronic medical record data from dozens of health care organizations, mainly in the United States. The network includes over 106 million patients. They looked at four cohorts: Patients without acne; those with acne but no current or prior use of systemic medications; those with acne managed with isotretinoin (and no prior use of oral tetracycline-class antibiotics); and those with acne managed with oral tetracycline-class antibiotics (and no exposure to isotretinoin).

Ocskay Bence/Fotolia.com

For the acne cohorts, the investigators captured first encounters with a diagnosis of acne and first prescriptions of interest. And studywide, they used propensity score matching to balance cohorts for age, sex, race, ethnicity, and combined oral contraceptive use.

“These data should provide more reassurance to patients and prescribers that isotretinoin does not appear to result in a meaningfully increased risk of inflammatory bowel disease,” they wrote in the study, published online in the Journal of the American Academy of Dermatology.

“These are important findings as isotretinoin is a valuable treatment for acne that can result in a durable remission of disease activity, prevent acne scarring, and reduce our overreliance on oral antibiotics for acne,” they added.

Indeed, dermatologist Jonathan S. Weiss, MD, who was not involved in the research and was asked to comment on the study, said that the findings “are reassuring given the large numbers of patients evaluated and treated.” The smallest cohort – the isotretinoin group – had over 11,000 patients, and the other cohorts had over 100,000 patients each, he said in an interview.

“At this point, I’m not sure we need any other immediate information to feel comfortable using isotretinoin with respect to a potential to cause IBD, but it would be nice to see some longitudinal follow-up data for longer-term reassurance,” added Dr. Weiss, who practices in Snellville, Georgia, and is on the board of the directors of the American Acne and Rosacea Society.

 

The findings: Risk with acne

To assess the potential association between acne and IBD, the researchers identified more than 350,000 patients with acne managed without systemic medications, and propensity score matched them with patients who did not have acne. Altogether, their mean age was 22; 32.1% were male, and 59.6% were White.

Compared with the controls who did not have acne, they found a statistically significant association between acne and risk of incident IBD (odds ratio, 1.42; 95% confidence interval, 1.23-1.65) and an absolute risk difference of .04%. Separated into Crohn’s disease (CD) and ulcerative colitis (UC), ORs were 1.56 and 1.62, respectively.
 

Tetracyclines

To assess the association of oral tetracycline use and IBD, they compared more than 144,000 patients whose acne was managed with antibiotics with patients whose acne was managed without systemic medications. The patients had a mean age of 24.4; 34.7% were male, and 68.2% were White.

Compared with the patients who were not on systemic medications, there were no significant associations among those on oral tetracyclines, with an OR for incident IBD of 1 (95% CI, 0.82-1.22), an OR for incident CD of 1.09 (95% CI, 0.86-1.38), and an OR for UC of 0.78 (95% CI, 0.61-1.00).
 

Isotretinoin

To evaluate the association of isotretinoin and IBD, the researchers compared more than 11,000 patients treated with isotretinoin with two matched groups: patients with acne managed without systemic medications, and patients with acne managed with oral tetracyclines. The latter comparison was made to minimize potential confounding by acne severity. These patients had a mean age of 21.1; 49.5% were male, and 75.3% were White.

In the first comparison, compared with patients not treated with systemic medications, the OR for 1-year incidence of IBD among patients treated with isotretinoin was 1.29 (95% CI, 0.64-2.59), with an absolute risk difference of .036%. The ORs for CD and UC were 1.00 (95% CI, 0.45-2.23) and 1.27 (95% CI, .58-2.80), respectively.

And compared with the antibiotic-managed group, the OR for incident IBD among those on isotretinoin was 1.13 (95% CI, 0.57-2.21), with an absolute risk difference of .018%. The OR for CD was 1.00 (95% CI, 0.45-2.23). The OR for UC could not be accurately estimated because of an insufficient number of events in the tetracycline-treated group.
 

‘Challenging’ area of research

Researching acne treatments and the potential risk of IBD has been a methodologically “challenging topic to study” because of possible confounding and surveillance bias depending on study designs, Dr. Barbieri, director of the Brigham and Women’s Advanced Acne Therapeutics Clinic, said in an interview.

Studies that have identified a potential association between isotretinoin and IBD often have not adequately controlled for prior antibiotic exposure, for instance. And other studies, including a retrospective cohort study also published recently in JAAD using the same TriNetX database, have found 6-month isotretinoin-related risks of IBD but no increased risk at 1 year or more of follow-up – a finding that suggests a role of surveillance bias, Dr. Barbieri said.

The follow-up period of 1 year in their new study was chosen to minimize the risk of such bias. “Since patients on isotretinoin are seen more often, and since there are historical concerns about isotretinoin and IBD, patients on isotretinoin may be more likely to be screened earlier and thus could be diagnosed sooner than those not on [the medication],” he said.

He and his coauthors considered similar potential bias in designing the no-acne cohort, choosing patients who had routine primary care visits without abnormal findings in order to “reduce potential for bias due to frequency of interaction with the health care system,” they noted in their paper. (Patients had no prior encounters for acne and no history of acne treatments.)
 

Antibiotics, acne itself

Research on antibiotic use for acne and risk of IBD is scant, and the few studies that have been published show conflicting findings, Dr. Barbieri noted. In the meantime, studies and meta-analyses in the general medical literature – not involving acne – have identified an association between lifetime oral antibiotic exposure and IBD, he said.

While the results of the new study “are reassuring that oral tetracycline-class exposure for acne may not be associated with a significant absolute risk of inflammatory bowel disease, given the potential for antibiotic resistance and other antibiotic-associated complications, it remains important to be judicious” with their use in acne management, he and his coauthors wrote in the study.

The potential association between antibiotics for acne and IBD needs further study, preferably with longer follow-up duration, Dr. Barbieri said in the interview, but researchers are challenged by the lack of datasets with high-quality longitudinal data “beyond a few years of follow-up.”

The extent to which acne itself is associated with IBD is another area ripe for more research. Thus far, it seems that IBD and acne – and other chronic inflammatory skin diseases such as psoriasis – involve similar pathogenic pathways. “We know that in IBD Th17 and TNF immunologic pathways are important, so it’s not surprising that there may be associations,” he said.

In their paper, Dr. Barbieri and his coauthors emphasize, however, that the absolute risk difference between acne and IBD is small. It’s “unlikely that population level screening is warranted among patients with acne,” they wrote.

A second new study

The other study, also published recently in JAAD, used the same TriNetX research platform to identify approximately 77,000 patients with acne starting isotretinoin and matched them with patients starting oral antibiotics.

The investigators, Khalaf Kridin MD, PhD, and Ralf J. Ludwig, MD, of the Lübeck Institute of Experimental Dermatology, University of Lübeck (Germany), found that the lifetime risks (greater than 6 months) for patients on isotretinoin were not significantly elevated, compared with those on oral antibiotics for either CD (hazard ratio 1.05; 95% CI, 0.89-1.24, P = .583) or UC (HR, 1.13; 95% CI, 0.95-1.34; P = .162) They also looked at the risk of irritable bowel syndrome (IBS) and found a lower lifetime risk in the isotretinoin group.

In the short term, during the first 6 months after drug initiation, there was a significant, but slight increase in UC in the isotretinoin group. But this risk decreased to the level of the antibiotic group with longer follow up. “The absolute incidence rates [of IBD] and the risk difference of UC within the first 6 months are of limited clinical significance,” they wrote.

It may be, Dr. Weiss said in commenting on this study, “that isotretinoin unmasks an already-existing genetic tendency to UC early on in the course of treatment, but that it does not truly cause an increased incidence of any type of IBD.”

Both studies, said Dr. Barbieri, “add to an extensive body of literature that supports that isotretinoin is not associated with IBD.”

Dr. Barbieri had no disclosures for the study, for which Matthew T. Taylor served as first author. Coauthor Shawn Kwatra, MD, disclosed that he is an advisory board member/consultant for numerous pharmaceutical companies and has served as an investigator for several. Both are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The other authors had no disclosures. Dr. Kridin and Dr. Ludwig had no disclosures for their study. Dr. Weiss had no disclosures.

Almonds might affect appetite during a weight loss diet and may assist with weight management in the long term, according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.

What to know

People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.

People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.

Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.

Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.

Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.

A version of this article originally appeared on Medscape.com.

This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.

Almonds might affect appetite during a weight loss diet and may assist with weight management in the long term, according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.

What to know

People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.

People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.

Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.

Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.

Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.

A version of this article originally appeared on Medscape.com.

This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.

Almonds might affect appetite during a weight loss diet and may assist with weight management in the long term, according to researchers at the University of South Australia’s Alliance for Research in Exercise, Nutrition and Activity.

What to know

People who consume as few as 30-50 g of almonds, as opposed to an energy-equivalent carbohydrate snack, can lower their energy intake significantly at the subsequent meal.

People who eat almonds can experience changes in their appetite-regulating hormones that may contribute to less food intake.

Almond consumption can lower C-peptide responses, which can improve insulin sensitivity and reduce the risk of developing diabetes and cardiovascular disease.

Eating almonds can raise levels of glucose-dependent insulinotropic polypeptide glucagon, which can send satiety signals to the brain, and pancreatic polypeptide, which slows digestion, which may reduce food intake, supporting weight loss.

Almonds are high in protein, fiber, and unsaturated fatty acids, which may contribute to their satiating properties and help explain why fewer calories are consumed.

A version of this article originally appeared on Medscape.com.

This is a summary of the article “Acute Feeding With Almonds Compared to a Carbohydrate-Based Snack Improves Appetite-Regulating Hormones With No Effect on Self-reported Appetite Sensations: A Randomised Controlled Trial,” published in the European Journal of Nutrition on Oct. 11, 2022. The full article can be found on link.springer.com.