Clinician Reviews

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

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

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

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

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

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

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

(Reuters) – Eli Lilly’s COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.

The announcement on Nov. 30 takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer’s antiviral drug Paxlovid, Merck’s Lagevrio, and Gilead Sciences’ Veklury as treatments for the disease, besides convalescent plasma for some patients.

AstraZeneca’s monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people.

Eli Lilly and its authorized distributors have paused commercial distribution of the monoclonal antibody until further notice from the agency, while the U.S. government has also paused fulfillment of any pending requests under its scheme to help uninsured and underinsured Americans access the drug.

The drug, which was discovered by Abcellera and commercialized by Eli Lilly, received an authorization from the FDA in February.

BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last 2 months, surpassing Omicron’s BA.5 subvariant, which had driven cases earlier in the year.

The subvariants accounted for around 57% of the cases nationally, as per government data last week.

Reuters Health Information © 2022 

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

Doctors suspect the worst respiratory syncytial virus (RSV) season in years just ended, and the story of a child who had a serious respiratory infection provides a glimpse of what health care providers saw in the fall of 2022.

RSV cases peaked in mid-November, according to the latest Centers for Disease Control and Prevention data, with RSV-associated hospitalizations in the United States among patients 0-4 years having maxed out five times higher than they were at the same time in 2021. These surges strained providers and left parents scrambling for care. Fortunately, pediatric hospitalizations appear to be subsiding.

In interviews, the parents of the child who had a severe case of RSV reflected on their son’s bout with the illness, and doctors described challenges to dealing with the surge in RSV cases this season. The physicians also offered advice on how recognize and respond to future cases of the virus.
 

Sebastian Witt’s story

“I didn’t even know what RSV was,” said Malte Witt, whose son, Sebastian, 2, was recently hospitalized for RSV in Denver.

Mr. Witt and his wife, Emily Witt, both 32, thought they were dealing with a typical cold until Sebastian’s condition dramatically deteriorated about 36 hours after symptom onset.

“He basically just slumped over and collapsed, coughing uncontrollably,” Mr. Witt said in an interview. “He couldn’t catch his breath.”

The Witts rushed Sebastian to the ED at Children’s Hospital Colorado, expecting to see a doctor immediately. Instead, they spent the night in an overcrowded waiting room alongside many other families in the same situation.

“There was no room for anyone to sit anywhere,” Mr. Witt said. “There were people sitting on the floor. I counted maybe six children hooked up to oxygen when we walked in.”

After waiting approximately 45 minutes, a nurse checked Sebastian’s oxygen saturation. The readings were 79%-83%. This range is significantly below thresholds for supplemental oxygen described by most pediatric guidelines, which range from 90 to 94%.

The nurse connected Sebastian to bottled oxygen in the waiting room, and a recheck 4 hours later showed that his oxygen saturation had improved.

But the improvement didn’t last.

“At roughly hour 10 in the waiting room – it was 4 in the morning – you could tell that Seb was exhausted, really not acting like himself,” Mr. Witt said. “We thought maybe it’s just late at night, he hasn’t really slept. But then Emily noticed that his oxygen tank had run out.”

Mr. Witt told a nurse, and after another check revealed low oxygen saturation, Sebastian was finally admitted.
 

Early RSV surge strains pediatric providers

With RSV-associated hospitalizations peaking at 48 per 100,000 children, Colorado has been among the states hardest hit by the virus. New Mexico – where hospitalizations peaked at 56.4 per 100,000 children – comes in second. Even in states like California, where hospitalization rates have been almost 10-fold lower than New Mexico, pediatric providers have been stretched to their limits.

“Many hospitals are really being overwhelmed with admissions for RSV, both routine RSV – relatively mild hospitalizations with bronchiolitis – as well as kids in the ICU with more severe cases,” said Dean Blumberg, MD, chief of the division of pediatric infectious diseases at UC Davis Health, Sacramento, said in an interview.

Dr. Blumberg believes the severity of the 2022-2023 RSV season is likely COVID related.

“All community-associated respiratory viral infections are out of whack because of the pandemic, and all the masking and social distancing that was occurring,” he said.

This may also explain why older kids are coming down with more severe cases of RSV.

“Some children are getting RSV for the first time as older children,” Dr. Blumberg said, noting that, historically, most children were infected in the first 2 years of life. “There are reports of children 3 or 4 years of age being admitted with their first episode of RSV because of the [COVID] pandemic.”

This year’s RSV season is also notable for arriving early, potentially catching the community off guard, according to Jennifer D. Kusma, MD, a primary care pediatrician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

“People who should have been protected often weren’t protected yet,” Dr. Kusma said in an interview.
 

Treatments new, old, and unproven

On Nov. 17, in the midst of the RSV surge, the American Academy of Pediatrics issued updated guidance for palivizumab, an RSV-targeting monoclonal antibody labeled for children at risk of severe RSV, including those with pre-existing lung or heart conditions, and infants with a history of premature birth (less than or equal to 35 weeks’ gestational age).

“If RSV disease activity persists at high levels in a given region through the fall and winter, the AAP supports providing more than five consecutive doses of palivizumab to eligible children,” the update stated.

Insurance companies appear to be responding in kind, covering additional doses for children in need.

“[Payers] have agreed that, if [palivizumab] needs to be given for an additional month or 2 or 3, then they’re making a commitment that they’ll reimburse hospitals for providing that,” Dr. Blumberg said.

For ineligible patients, such as Sebastian, who was born prematurely at 36 weeks – 1 week shy of the label requirement – treatment relies upon supportive care with oxygen and IV fluids.

At home, parents are left with simpler options.

Dr. Blumberg and Dr. Kusma recommended keeping children hydrated, maintaining humidified air, and using saline nose drops with bulb suction to clear mucus.

In the Witts’ experience, that last step may be easier said than done.

“Every time a nurse would walk into the room, Sebastian would yell: ‘Go away, doctor! I don’t want snot sucker!’” Mr. Witt said.

“If you over snot-suck, that’s really uncomfortable for the kid, and really hard for you,” Ms. Witt said. “And it doesn’t make much of a difference. It’s just very hard to find a middle ground, where you’re helping and keeping them comfortable.”

Some parents are turning to novel strategies, such as nebulized hypertonic saline, currently marketed on Amazon for children with RSV.

Although the AAP offers a weak recommendation for nebulized hypertonic saline in children hospitalized more than 72 hours, they advise against it in the emergency setting, citing inconsistent findings in clinical trials.

To any parents tempted by thousands of positive Amazon reviews, Dr. Blumberg said, “I wouldn’t waste my money on that.”

Dr. Kusma agreed.

“[Nebulized hypertonic saline] can be irritating,” she said. “It’s saltwater, essentially. If a parent is in the position where they’re worried about their child’s breathing to the point that they think they need to use it, I would err on the side of calling your pediatrician and being seen.”
 

Going in, coming home

Dr. Kusma said parents should seek medical attention if a child is breathing faster and working harder to get air. Increased work of breathing is characterized by pulling of the skin at the notch where the throat meets the chest bone (tracheal tugging), and flattening of the belly that makes the ribcage more prominent.

Mr. Witt saw these signs in Sebastian. He knew they were significant, because a friend who is a nurse had previously shown him some examples of children who exhibited these symptoms online.

“That’s how I knew that things were actually really dangerous,” Mr. Witt said. “Had she not shown me those videos a month and a half before this happened, I don’t know that we would have hit the alarm bell as quickly as we did.”

After spending their second night and the following day in a cramped preoperative room converted to manage overflow from the emergency department, Sebastian’s condition improved, and he was discharged. The Witts are relieved to be home, but frustrations from their ordeal remain, especially considering the estimated $5,000 in out-of-pocket costs they expect to pay.

“How is this our health care system?” Ms. Witt asked. “This is unbelievable.”
 

An optimistic outlook

RSV seasons typically demonstrate a clear peak, followed by a decline through the rest of the season, suggesting better times lie ahead; however, this season has been anything but typical.

“I’m hopeful that it will just go away and stay away,” Dr. Kusma said, citing this trend. “But I can’t know for sure.”

To anxious parents, Dr. Blumberg offered an optimistic view of RSV seasons to come.

“There’s hope,” he said. “There are vaccines that are being developed that are very close to FDA approval. So, it’s possible that this time next year, we might have widespread RSV vaccination available for children so that we don’t have to go through this nightmare again.”

Dr. Blumberg and Dr. Kusma disclosed no relevant conflicts of interest.

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.

“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.

“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”

The study was published online in the American Journal of Gastroenterology.
 

Online yoga program vs. IBS advice only

IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.

During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.

Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.

The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.

The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.

The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.

The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.

The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.

They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.

Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.

The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.

In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.

Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.

Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.

No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.

“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”

The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
 

Future program considerations

Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.

“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”

Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.

“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.

Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.

“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”

The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.

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

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.

“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.

“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”

The study was published online in the American Journal of Gastroenterology.
 

Online yoga program vs. IBS advice only

IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.

During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.

Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.

The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.

The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.

The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.

The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.

The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.

They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.

Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.

The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.

In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.

Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.

Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.

No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.

“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”

The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
 

Future program considerations

Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.

“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”

Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.

“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.

Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.

“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”

The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.

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

An online yoga program appears to be effective, feasible, and safe for patients with irritable bowel syndrome (IBS), according to a new report.

Participants reported a decrease in IBS-related symptoms and improvements in quality of life, fatigue, and perceived stress.

“IBS affects upwards of 15%-20% of the North American population, and despite our advances in the area, we have very limited options to offer our patients,” Maitreyi Raman, MD, an associate professor of medicine at the University of Calgary (Alta.), said in an interview.

“Often, we are focused on treating symptoms but not addressing the underlying cause,” said Dr. Raman, who is director of Alberta’s Collaboration of Excellence for Nutrition in Digestive Diseases. “With advances around the gut microbiome and the evolving science on the brain-gut axis, mind-body interventions could offer a therapeutic option that patients can use to improve the overall course of their disease.”

The study was published online in the American Journal of Gastroenterology.
 

Online yoga program vs. IBS advice only

IBS often involves alterations of the gut-brain axis and can be affected by psychological or physiological stress, the study authors write. Previous studies have found that in-person yoga programs can manage IBS symptoms and improve physiological, psychological, and emotional health.

During the COVID-19 pandemic, yoga programs had to switch to a virtual format – a delivery method that could remain relevant due to limited health care resources. However, the efficacy, feasibility, and safety of virtual yoga for people with IBS were unknown.

Dr. Raman and colleagues conducted a randomized, two-group, controlled clinical trial at the University of Calgary (Alta.) between March 2021 and December 2022. The 79 participants weren’t blinded to the trial arms – an online yoga program or an advice-only control group.

The eligible participants had a diagnosis of IBS, scored at least 75 out of 500 points on the IBS Symptoms Severity Scale (IBS-SSS) for mild IBS, and were on stable doses of medications for IBS. They were instructed to continue with their current therapies during the study but didn’t start new medications or make major changes to their diet or physical patterns.

The yoga program was based on Upa Yoga, a subtype of Hatha Yoga developed by the Isha Foundation of Inner Sciences. The program was delivered by a certified yoga facilitator from the Isha Foundation and included directional movements, neck rotations, breathing practices, breath watching, and mantra meditation with aum/om chanting.

The online classes of three to seven participants were delivered in 60-minute sessions for 8 weeks. The participants were also asked to practice at home daily with the support of yoga videos.

The advice-only control group included a 10-minute video with general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in managing IBS. The participants received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient support group, and information about physical activity guidelines from the World Health Organization.

The research team looked for a primary endpoint of at least a 50-point reduction on the IBS-SSS, which is considered clinically meaningful.

They also measured for secondary outcomes, such as quality of life, anxiety, depression, perceived stress, COVID-19–related stress, fatigue, somatic symptoms, self-compassion, and intention to practice yoga.

Among the 79 participants, 38 were randomized to the yoga program and 41 were randomized to the advice-only control group. The average age was 45 years. Most (92%) were women, and 81% were White. The average IBS duration since diagnosis was 11.5 years.

The overall average IBS-SSS was moderate, at 245.3, at the beginning of the program, and dropped to 207.9 at week 8. The score decreased from 255.2 to 200.5 in the yoga group and from 236.1 to 213.5 in the control group. The difference between the groups was 32 points, which wasn’t statistically significant, though symptom improvement began after 4 weeks in the yoga group.

In the yoga group, 14 participants (37%) met the target decrease of 50 points or more, compared with eight participants (20%) in the control group. These 22 “responders” reported improvements in IBS symptoms, quality of life, perceived stress, and COVID-19–related stress.

Specifically, among the 14 responders in the yoga group, there were significant improvements in IBS symptoms, quality of life, fatigue, somatic symptoms, self-compassion, and COVID-19–related stress. In the control group, there were significant improvements in IBS symptoms and COVID-19–related stress.

Using an intent-to-treat analysis, the research team found that the yoga group had improved quality of life, fatigue, and perceived stress. In the control group, improvements were seen only in COVID-19–related stress.

No significant improvements were found in anxiety or depression between the groups, although the changes in depression scores were in favor of the yoga group. The intention to practice yoga dropped in both groups during the study period, but it wasn’t associated with the actual yoga practice minutes or change in IBS-SSS scores.

“We saw a surprising improvement in quality of life,” Dr. Raman said. “Although we talk about quality of life as an important endpoint, it can be hard to show in studies, so that was a nice finding to demonstrate in this study.”

The yoga intervention was feasible in terms of adherence (79%), attrition rate (20%), and high program satisfaction, the researchers write. Safety was demonstrated by the absence of any adverse events.
 

Future program considerations

Dr. Raman and colleagues are interested in understanding the mechanisms that underlie the efficacy of mind-body interventions. They also plan to test the virtual yoga program in a mobile app, called LyfeMD, which is intended to support patients with digestive diseases through evidence-based dietary programs and mind-body interventions, such as guided meditation, breathing exercises, and cognitive behavioral therapy.

“We know that patients are looking for all possible resources,” Dr. Raman said. “Our next goal is to better understand how an app-based intervention can be effective, even without a live instructor.”

Future studies should also consider clinicians’ perspectives, she noted. In previous studies, Dr. Raman and colleagues have found that physicians are open to recommending yoga as a therapeutic option for patients, but some are unsure how to prescribe a recommended dose, frequency, or type of yoga.

“When treating patients with IBS, it is important to think broadly and creatively about all our treatment options,” said Elyse Thakur, PhD, a clinical health psychologist at Atrium Health Gastroenterology and Hepatology, Charlotte, N.C.

Dr. Thakur, who wasn’t involved with this study, specializes in gastrointestinal health psychology. She and colleagues use numerous complementary and alternative medicine options with patients.

“We have to remember that people may respond differently to available treatment options,” she said. “It is imperative to understand the evidence so we can have productive conversations with our patients about the pros and cons and the potential benefits and limitations.”

The study did not receive a specific grant from a funding agency. The authors and Dr. Thakur declared no relevant financial relationships.

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

LAS VEGAS – The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – The delay in the diagnosis of hidradenitis suppurativa (HS) often ranges from 7 to 10 years, which results in increased morbidity and disease severity, and an extended impact on quality of life, Robert G. Micheletti, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

For patients with HS, “the quality-of-life impact is profound, greater than any other systematically studied dermatologic condition,” said Dr. Micheletti, associate professor of dermatology at the Hospital of the University of Pennsylavnia, and chief of hospital dermatology, and chief of dermatology at Pennsylvania Hospital, Philadelphia.

Two key aspects of quality of life that affect HS patients are sexual health and overall pain, he said. The female-to-male ratio of HS is approximately 3:1, and data show that approximately 40% of female HS patients experience fertility issues and have unaddressed questions about HS and pregnancy, said Dr. Micheletti. Additionally, data from a systematic review showed that 50%-60% of patients with HS reported sexual dysfunction. Impaired sexual function is also associated with both overall impaired quality of life ratings and the presence of mood disorders, he noted.

Wikimedia Commons/Creative Commons Attribution-Share Alike 4.0 International

Pain also has a significant impact on quality of life for HS patients. When these patients present in an emergency department, 70% report severe pain, and approximately 60% receive opioids, said Dr. Micheletti.

Data from a 2021 study showed that HS patients are significantly more likely to receive opioids compared with controls, and also more likely to be diagnosed with opioid use disorder than controls, especially if they are seen by nondermatologists, he noted.

For acute pain, Dr. Micheletti recommended starting with acetaminophen 500 mg every 4 to 6 hours as needed, and topical nonsteroidal anti-inflammatory drugs (NSAIDs). “It still makes sense to do topical care,” said Dr. Micheletti, but he added that he also prescribes medications for anxiety for these patients.

Patients with increased pain severity or refractory disease may benefit from systemic NSAIDs, or intralesional triamcinolone, he noted. Incision and draining of abscesses may provide temporary symptomatic relief, but keep in mind that lesions will recur, he noted.

For the most severe cases, Dr. Micheletti advised adding tramadol as a first-line opioid, or another short-acting opioid for breakthrough pain.

To manage patients with HS who have chronic pain, Dr. Micheletti recommended starting with HS disease–directed therapy, but also screening for pain severity and psychological comorbidities.

His strategies in these cases include nonpharmacological pain management in the form of physical therapy, wound care, and behavioral health. His algorithm for nociceptive pain is NSAIDs with or without acetaminophen; duloxetine or nortriptyline are other options. For neuropathic pain, gabapentin and/or duloxetine are top choices, but pregabalin, venlafaxine, and nortriptyline are on the list as well.

Topical NSAIDs or topical lidocaine may serve as add-ons to systemic therapy in more severe cases, or as first-line therapy for milder chronic pain, Dr. Micheletti noted. Patients who have failed treatment with at least two pharmacologic agents, suffer medically refractory HS with debilitating pain, or use opioids on an ongoing basis should be referred to a pain management specialist, he said.
 

Don’t forget lifestyle

Although data on the impact of diet on patients with HS are limited, “we know anecdotally that dairy and refined carbohydrates are associated with exacerbations,” said Dr. Micheletti.

In addition, many patients use complementary medicine “and they aren’t always telling us,” he emphasized. Smoking is prevalent among patients with HS, and is a risk factor for the disease in general, and for more severe and refractory disease, he added. Consequently, screening for tobacco smoking is recommended for patients with HS not only because of the impact on disease, but because it is a potentially modifiable cardiovascular risk factor, he explained.
 

Consider comorbidities

Cardiovascular disease is among several comorbidities associated with HS, said Dr. Micheletti. HS foundations in the United States and Canada recently published evidence-based recommendations for comorbidity screening. The recommendations included screening for 19 specific comorbidities: acne, dissecting cellulitis, pilonidal disease, pyoderma gangrenosum, depression, anxiety, suicide, smoking, substance abuse, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction.

Dr. Micheletti highlighted cardiovascular comorbidities, and noted the association between HS and modifiable cardiovascular risk factors: smoking, obesity, diabetes mellitus, and dyslipidemia. “HS is also independently associated with cardiovascular disease leading to myocardial infarction, stroke, cardiovascular-associated death, and all-cause mortality compared to controls,” he said. Studies show an incidence rate ratio of 1.53 for major adverse cardiovascular events in patients with HS compared with controls, with the highest relative risk among those aged 18-29 years, he added.
 

Medical management

Depending on the patient, medical management of HS may involve antibiotics, hormonal agents, and biologics, said Dr. Micheletti. Some of the most commonly used antibiotic regimens for HS are those recommended in treatment guidelines, including doxycycline and a clindamycin/rifampin combination, he said. However, the use of trimethoprim-sulfamethoxazole or ciprofloxacin has been associated with increased antibiotic resistance and is not supported by available evidence, he noted.

Hormonal therapies may help some women with HS, said Dr. Micheletti. Options include spironolactone, metformin, or estrogen-containing hormonal contraceptives, he said.

When it comes to biologics, only 33% of HS patients meet criteria for their use (Hurley stage II or III, moderate or severe HS), he noted. However, research suggests “a huge gap” in the use of anti-TNF therapy even among patients for whom it is recommended, he said.

Of the TNF-alpha inhibitors, data on adalimumab, which is FDA-approved for HS, are the most recent. Adalimumab “is our gold standard biologic and our gateway biologic, for HS at this time,” Dr. Micheletti said.

However, those who respond to adalimumab “can continue to do better, but they can wax and wane and flare,” he cautioned. Infliximab, while not approved for HS, has been studied in patients with HS and is prescribed by some providers. Although no comparative studies have been done for infliximab versus adalimumab, “anecdotally, response to infliximab tends to be better, and it is the most effective biologic in common use for severe HS,” he noted.

Dr. Micheletti’s top treatment recommendations for using biologics start with considering biosimilars. Most patients on biosimilars do fine, but some patients who previously responded to infliximab will unpredictably lose efficacy or have reactions when switched to a biosimilar, he said.

Patients on biologics also may experience waning efficacy in the wake of an immune response stimulated by foreign antibodies, said Dr. Micheletti. “Anti-drug antibody formation is more likely to occur when treatment is interrupted,” he noted. Minimize the risk of antibody formation by paying attention to adherence issues and dosing frequency, he advised.

If patients fail both adalimumab and infliximab, Dr. Micheletti tells them not to lose hope, and that treatment is a trial-and-error process that may involve more than one therapy. Other biologics in active use for HS include ustekinumab, anakinra, secukinumab, brodalumab, golimumab, and JAK inhibitors, any of which might be effective in any given patient, he said.
 

Surgical solutions

For HS patients with chronic, recurring inflammation and drainage associated with a sinus tract, surgical deroofing may the best treatment option, Dr. Micheletti said. “Deroofing involves the use of a probe to trace the extent of the subcutaneous tract, followed by incision and removal of the tract ‘roof,’ ’’ he explained. The deroofing procedure involves local anesthesia and has a low morbidity rate, as well as a low recurrence rate and high levels of patient satisfaction, he said.

“The acute role for surgery is to remove active foci of inflammation and relieve pain,” which is achieved more effectively with deroofing, said Dr. Micheletti. By contrast, incision and drainage is associated with an almost 100% recurrence rate, he added.

When planning elective surgery for HS, Dr. Micheletti noted that holding infliximab for less than 4 weeks does not affect postoperative infection rates in patients with rheumatoid arthritis, and a recent randomized, controlled trial showed that adalimumab can be continued safely through HS surgeries.

In fact, “continuing TNF inhibitors through elective surgery does not increase infection risk and results in better disease control,” and dermatologists should work with surgery to balance infection and disease flare concerns in HS patients, he said.

Dr. Micheletti disclosed serving as a consultant or advisor for Adaptimmune and Vertex, and research funding from Amgen and Cabaletta Bio. MedscapeLive and this news organization are owned by the same parent company.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

An early and influential paper on long COVID that appeared in The Lancet has been flagged with an expression of concern while the journal investigates “data errors” brought to light by a reader.

An editorial that accompanied the paper when it was published in January of last year described it as “the first large cohort study with 6-months’ follow-up” of people hospitalized with COVID-19. The article has received plenty of attention since then.

Titled “6-month consequences of COVID-19 in patients discharged from hospital: a cohort study,” the paper has been cited nearly 1,600 times, according to Clarivate’s Web of Science. Altmetric finds references to it in multiple documents from the World Health Organization.

According to the expression of concern, dated November 24, a reader found inconsistencies between the data in the article and a later paper describing the same cohort of patients after a year of follow-up. That discovery sparked an investigation that is still ongoing:

• On Jan 8, 2021, The Lancet published an Article, 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study, by Chaolin Huang and colleagues. 1 On Aug 28, 2021, The Lancet published an Article, 1-year outcomes in hospital survivors with COVID-19: a longitudinal cohort study, by Lixue Huang and colleagues. 2 We received an inquiry from a researcher on data inconsistencies between these two Articles, and we sought an explanation from the corresponding author of the two papers. On Nov 7, 2022, Lancet editors were informed that inconsistencies between the 6-month and the 1-year data were due to “some variables in the dataset used for the 6-month paper were mistakenly disrupted in order”. In view of the extent of these data errors, we now issue an Expression of Concern about the 6-month paper 1 while we investigate further, including further statistical and clinical review of the corrected data. We will update this notice as soon as we have further information.

The corresponding author of both papers, Bin Cao of China’s National Center for Respiratory Medicine and the China-Japan Friendship Hospital in Beijing, has not responded to our request for comment.

A profile of Cao published in Lancet Infectious Diseases last March described him as “a leading researcher in pneumonia and influenza” who “has been instrumental in increasing knowledge about COVID-19.” In addition to the follow-up study of hospitalized COVID patients:

• Cao’s seminal papers during the COVID-19 pandemic include the first report of the clinical characteristics of COVID-19 patients in Wuhan, the description of the risk factors for mortality for adult inpatients, and the results of trials testing the use of antiviral drugs, including lopinavir-ritonavir, to treat COVID-19 in China.

We reached out to The Lancet’s press office and Richard Horton, the journal’s editor-in-chief, and received this statement:

• The Lancet Group treats all communications between editors and authors or readers as confidential. Investigations are continuing, and the Expression of Concern will be updated as soon as we have further information to share. More information about our policies is available here: 

This year, The Lancet overtook the New England Journal of Medicine as the medical journal with the highest impact factor, in large part due to the papers it published about COVID-19.

We’ve counted retractions for three of those papers, most notably a paper about the use of the drug hydroxychloroquine that claimed to use medical data from a company called Surgisphere. As Retraction Watch readers may remember, the article was retracted after sleuths questioned if the data were real, and the company would not produce it for review.

This article first appeared on Retraction Watch.

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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

CHICAGO – A single chest x-ray could predict a patient’s 10-year risk of dying from a heart attack or stroke, say researchers who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.

Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.

The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
 

Not all data points available in EHR

But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.

Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.

The researchers trained a deep-learning model with single chest x-rays only.

They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.

Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.

They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.

“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
 

Tested against independent group

They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.

Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.

There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).

Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.

They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).

Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.

“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.

“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.

David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.

“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”

He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.

Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.

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