Endocrinology

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

THE CASE

A 26-year-old woman presented to the emergency department (ED) with a history of nausea and vomiting for more than 24 hours. The vomiting began when she awoke to breastfeed her 3-month-old infant. She had been unable to eat or drink anything for about 16 hours.

She’d seen her primary care provider earlier in the day. Antiemetics were prescribed, but they did not provide relief. So 10 hours later, when her symptoms worsened, she presented to the ED.

Her medical history was notable for a body mass index of 26. The patient also reported positional back pain, but the review of systems was otherwise negative. The patient indicated that she’d been on a ketogenic diet for about 1 month, but she denied use of supplements.

Upon presentation to the ED, the patient was found to have a metabolic acidosis with a pH of 7.02 and an anion gap of 25. Her glucose level was 132 mg/dL, and she had a positive serum acetone and a beta-hydroxybutyrate level of 75 mg/dL (reference range, 0-2.8 mg/dL). Her salicylate testing was negative, and her lactate level was 1.4 mmol/L (reference range, 0.4-2.0 mmol/L).

THE DIAGNOSIS

This patient, with severe acidosis and an elevated anion gap, received a diagnosis of starvation ketoacidosis—specifically, lactation ketoacidosis. Other causes of elevated anion gap metabolic acidosis were ruled out, including salicylate overdose, lactic acidosis, diabetic ketoacidosis, and other ingestions. The elevated acetone and beta-hydroxybutyrate levels confirmed the diagnosis. The patient was treated with a bolus of 1 L normal saline with 5% dextrose (D5NS) in the ED and admitted.

DISCUSSION

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets. The treatment approach has differed in previous reports in regard to insulin and bicarbonate use.^1-9

The use of bicarbonate is controversial in diabetic ketoacidosis and unlikely to be helpful in lactation ketoacidosis, but it is something to consider when the patient’s pH is < 6.9. Insulin use is likely unnecessary for lactation ketoacidosis, as metabolic derangements have been corrected without intervention.

Continue to: With an increasing prevalence of cases...

With an increasing prevalence of cases, we suggest a conservative approach for treatment based on this case presentation and review of other presentations. Our patient responded rapidly to conservative treatment with intravenous (IV) fluids (D5NS), a liberalized diet, and electrolyte repletion (described in detail later).

Suggested management

Once other causes of a patient’s signs and symptoms are excluded and the diagnosis of lactation ketoacidosis is made, you’ll want to follow the initial set of lab work with the following: a venous blood gas, basic metabolic panel, and testing of magnesium and phosphorous levels every 8 hours after initial presentation, with repletion as indicated. Some patients may require more frequent monitoring based on repletion of electrolytes.

The patient will initially require IV fluid resuscitation; the initial fluid of choice would be D5NS. Patients will likely need no more than 2 L, but this will depend on the degree of hypovolemia.

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets.

Diet should be advanced as tolerated and include no restriction of carbohydrates.

Previous reports have varied regarding continuation of breastfeeding and pumping. In this case, the patient continued to breastfeed without any adverse effects. Continuation of breastfeeding is unlikely to cause harm in these circumstances, but severity of symptoms (pain, nausea, vomiting) or unresolved acidosis may require discontinuation.

Continue to: Discharge should be determined...

Discharge should be determined by resolution of symptoms and correction of metabolic derangements. In previous reports, discharge time varied from 48 hours up to 144 hours, with most patients discharged on Day 2 or 3. Pending clinical factors, discharge is likely appropriate between 36 to 72 hours from time of admission.

Our patient received an additional 1 L of D5NS for continued signs of dehydration during admission. Her pH and electrolyte levels were monitored every 8 hours, with repletion of electrolytes as needed. Her acidosis, nausea, vomiting, and pain resolved within 36 hours. The patient continued to breastfeed her infant throughout her stay. With resolution of symptoms and metabolic derangements, the patient was discharged about 36 hours after admission. She was advised to follow up with her primary care provider within 1 week after discharge.

THE TAKEAWAY

As the popularity of low-carbohydrate diets increases, patients should be educated about the warning signs of clinically significant ketoacidosis. This information is especially important for those who are lactating, as this metabolic state increases predilection to ketoacidosis. When cases do present, conservative management with IV fluids and a liberalized diet is likely to be an appropriate course of care for most patients.

CORRESPONDENCE
C.W. Ferguson, DO, Navy Medicine Readiness and Training Command, Camp Lejeune Family Medicine Residency, 100 Brewster Boulevard, Camp Lejeune, NC 28547; cwfergus@gmail.com

THE CASE

A 26-year-old woman presented to the emergency department (ED) with a history of nausea and vomiting for more than 24 hours. The vomiting began when she awoke to breastfeed her 3-month-old infant. She had been unable to eat or drink anything for about 16 hours.

She’d seen her primary care provider earlier in the day. Antiemetics were prescribed, but they did not provide relief. So 10 hours later, when her symptoms worsened, she presented to the ED.

Her medical history was notable for a body mass index of 26. The patient also reported positional back pain, but the review of systems was otherwise negative. The patient indicated that she’d been on a ketogenic diet for about 1 month, but she denied use of supplements.

Upon presentation to the ED, the patient was found to have a metabolic acidosis with a pH of 7.02 and an anion gap of 25. Her glucose level was 132 mg/dL, and she had a positive serum acetone and a beta-hydroxybutyrate level of 75 mg/dL (reference range, 0-2.8 mg/dL). Her salicylate testing was negative, and her lactate level was 1.4 mmol/L (reference range, 0.4-2.0 mmol/L).

THE DIAGNOSIS

This patient, with severe acidosis and an elevated anion gap, received a diagnosis of starvation ketoacidosis—specifically, lactation ketoacidosis. Other causes of elevated anion gap metabolic acidosis were ruled out, including salicylate overdose, lactic acidosis, diabetic ketoacidosis, and other ingestions. The elevated acetone and beta-hydroxybutyrate levels confirmed the diagnosis. The patient was treated with a bolus of 1 L normal saline with 5% dextrose (D5NS) in the ED and admitted.

DISCUSSION

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets. The treatment approach has differed in previous reports in regard to insulin and bicarbonate use.^1-9

The use of bicarbonate is controversial in diabetic ketoacidosis and unlikely to be helpful in lactation ketoacidosis, but it is something to consider when the patient’s pH is < 6.9. Insulin use is likely unnecessary for lactation ketoacidosis, as metabolic derangements have been corrected without intervention.

Continue to: With an increasing prevalence of cases...

With an increasing prevalence of cases, we suggest a conservative approach for treatment based on this case presentation and review of other presentations. Our patient responded rapidly to conservative treatment with intravenous (IV) fluids (D5NS), a liberalized diet, and electrolyte repletion (described in detail later).

Suggested management

Once other causes of a patient’s signs and symptoms are excluded and the diagnosis of lactation ketoacidosis is made, you’ll want to follow the initial set of lab work with the following: a venous blood gas, basic metabolic panel, and testing of magnesium and phosphorous levels every 8 hours after initial presentation, with repletion as indicated. Some patients may require more frequent monitoring based on repletion of electrolytes.

The patient will initially require IV fluid resuscitation; the initial fluid of choice would be D5NS. Patients will likely need no more than 2 L, but this will depend on the degree of hypovolemia.

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets.

Diet should be advanced as tolerated and include no restriction of carbohydrates.

Previous reports have varied regarding continuation of breastfeeding and pumping. In this case, the patient continued to breastfeed without any adverse effects. Continuation of breastfeeding is unlikely to cause harm in these circumstances, but severity of symptoms (pain, nausea, vomiting) or unresolved acidosis may require discontinuation.

Continue to: Discharge should be determined...

Discharge should be determined by resolution of symptoms and correction of metabolic derangements. In previous reports, discharge time varied from 48 hours up to 144 hours, with most patients discharged on Day 2 or 3. Pending clinical factors, discharge is likely appropriate between 36 to 72 hours from time of admission.

Our patient received an additional 1 L of D5NS for continued signs of dehydration during admission. Her pH and electrolyte levels were monitored every 8 hours, with repletion of electrolytes as needed. Her acidosis, nausea, vomiting, and pain resolved within 36 hours. The patient continued to breastfeed her infant throughout her stay. With resolution of symptoms and metabolic derangements, the patient was discharged about 36 hours after admission. She was advised to follow up with her primary care provider within 1 week after discharge.

THE TAKEAWAY

As the popularity of low-carbohydrate diets increases, patients should be educated about the warning signs of clinically significant ketoacidosis. This information is especially important for those who are lactating, as this metabolic state increases predilection to ketoacidosis. When cases do present, conservative management with IV fluids and a liberalized diet is likely to be an appropriate course of care for most patients.

CORRESPONDENCE
C.W. Ferguson, DO, Navy Medicine Readiness and Training Command, Camp Lejeune Family Medicine Residency, 100 Brewster Boulevard, Camp Lejeune, NC 28547; cwfergus@gmail.com

THE CASE

A 26-year-old woman presented to the emergency department (ED) with a history of nausea and vomiting for more than 24 hours. The vomiting began when she awoke to breastfeed her 3-month-old infant. She had been unable to eat or drink anything for about 16 hours.

She’d seen her primary care provider earlier in the day. Antiemetics were prescribed, but they did not provide relief. So 10 hours later, when her symptoms worsened, she presented to the ED.

Her medical history was notable for a body mass index of 26. The patient also reported positional back pain, but the review of systems was otherwise negative. The patient indicated that she’d been on a ketogenic diet for about 1 month, but she denied use of supplements.

Upon presentation to the ED, the patient was found to have a metabolic acidosis with a pH of 7.02 and an anion gap of 25. Her glucose level was 132 mg/dL, and she had a positive serum acetone and a beta-hydroxybutyrate level of 75 mg/dL (reference range, 0-2.8 mg/dL). Her salicylate testing was negative, and her lactate level was 1.4 mmol/L (reference range, 0.4-2.0 mmol/L).

THE DIAGNOSIS

This patient, with severe acidosis and an elevated anion gap, received a diagnosis of starvation ketoacidosis—specifically, lactation ketoacidosis. Other causes of elevated anion gap metabolic acidosis were ruled out, including salicylate overdose, lactic acidosis, diabetic ketoacidosis, and other ingestions. The elevated acetone and beta-hydroxybutyrate levels confirmed the diagnosis. The patient was treated with a bolus of 1 L normal saline with 5% dextrose (D5NS) in the ED and admitted.

DISCUSSION

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets. The treatment approach has differed in previous reports in regard to insulin and bicarbonate use.^1-9

The use of bicarbonate is controversial in diabetic ketoacidosis and unlikely to be helpful in lactation ketoacidosis, but it is something to consider when the patient’s pH is < 6.9. Insulin use is likely unnecessary for lactation ketoacidosis, as metabolic derangements have been corrected without intervention.

Continue to: With an increasing prevalence of cases...

With an increasing prevalence of cases, we suggest a conservative approach for treatment based on this case presentation and review of other presentations. Our patient responded rapidly to conservative treatment with intravenous (IV) fluids (D5NS), a liberalized diet, and electrolyte repletion (described in detail later).

Suggested management

Once other causes of a patient’s signs and symptoms are excluded and the diagnosis of lactation ketoacidosis is made, you’ll want to follow the initial set of lab work with the following: a venous blood gas, basic metabolic panel, and testing of magnesium and phosphorous levels every 8 hours after initial presentation, with repletion as indicated. Some patients may require more frequent monitoring based on repletion of electrolytes.

The patient will initially require IV fluid resuscitation; the initial fluid of choice would be D5NS. Patients will likely need no more than 2 L, but this will depend on the degree of hypovolemia.

Lactation ketoacidosis is a relatively uncommon condition, but reports have increased with the growing popularity of low-carbohydrate diets.

Diet should be advanced as tolerated and include no restriction of carbohydrates.

Previous reports have varied regarding continuation of breastfeeding and pumping. In this case, the patient continued to breastfeed without any adverse effects. Continuation of breastfeeding is unlikely to cause harm in these circumstances, but severity of symptoms (pain, nausea, vomiting) or unresolved acidosis may require discontinuation.

Continue to: Discharge should be determined...

Discharge should be determined by resolution of symptoms and correction of metabolic derangements. In previous reports, discharge time varied from 48 hours up to 144 hours, with most patients discharged on Day 2 or 3. Pending clinical factors, discharge is likely appropriate between 36 to 72 hours from time of admission.

Our patient received an additional 1 L of D5NS for continued signs of dehydration during admission. Her pH and electrolyte levels were monitored every 8 hours, with repletion of electrolytes as needed. Her acidosis, nausea, vomiting, and pain resolved within 36 hours. The patient continued to breastfeed her infant throughout her stay. With resolution of symptoms and metabolic derangements, the patient was discharged about 36 hours after admission. She was advised to follow up with her primary care provider within 1 week after discharge.

THE TAKEAWAY

As the popularity of low-carbohydrate diets increases, patients should be educated about the warning signs of clinically significant ketoacidosis. This information is especially important for those who are lactating, as this metabolic state increases predilection to ketoacidosis. When cases do present, conservative management with IV fluids and a liberalized diet is likely to be an appropriate course of care for most patients.

CORRESPONDENCE
C.W. Ferguson, DO, Navy Medicine Readiness and Training Command, Camp Lejeune Family Medicine Residency, 100 Brewster Boulevard, Camp Lejeune, NC 28547; cwfergus@gmail.com

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

SAN DIEGO – In a review and meta-analysis of six small, head-to-head studies of bariatric surgery versus subcutaneous injection with a glucagon-like peptide-1 (GLP-1) agonist, weight loss was greater after the surgery, but glycemic control was similar after either treatment.

However, researchers have yet to directly compare bariatric surgery with new dual and even triple agonists that are in development.

The review by Shohinee Sarma, MD, MPH, and Patricia Palcu, MD, from the University of Toronto, was published  in Obesity. Dr. Sarma also presented the findings virtually at the Obesity journal symposium at ObesityWeek® 2022.

Eric Ravussin, PhD, outgoing editor-in-chief of Obesity, explained to in an interview that this is one of five articles the editors chose from about 20 papers submitted for consideration for the symposium, and it was selected because it is a first review and meta-analysis of this direct comparison.

It showed that in “a straight head-to-head comparison, weight loss is larger by about 20 kg (44 lb) with bariatric surgery versus a GLP-1 agonist, but the improvement in glycemia (carbohydrate metabolism) was similar,” said Dr. Ravussin, from Pennington Biomedical Research Center, Louisiana State University, Baton Rouge.

Study limitations, which the authors also acknowledge, include that this was a small review of small studies: There were only six studies and 322 patients.

Moreover, the data are from 2007 to 2017, and newer weight-loss drugs are more potent.

Most studies in the review compared bariatric surgery with liraglutide, Dr. Ravussin noted, whereas, “we have now better GLP-1 agonists like semaglutide,” as well as drugs that are combinations of a GLP-1 agonist with another agonist or agonists.

“Tirzepatide, for example, which is a combination of a GLP-1 agonist and a [glucose-dependent insulinotropic polypeptide (GIP) agonist], is showing results that are very close to weight loss with bariatric surgery,” he observed.

There are quite a few other drugs in development, too, he continued, which are going to approach the weight loss obtained with bariatric surgery.

Novo Nordisk is coming out with a combination of an amylin analog (cagrilintide) and a GLP-1 agonist (semaglutide), he noted. “There are others coming in with GLP-1 and glucagon [dual agonists], and there is even a ... combo called triple G, which is a glucagon, GLP-1, and GIP [agonist].”

We now need a head-to-head comparison between bariatric surgery versus a combination drug like tirzepatide in a large population, he said.

“This is an exciting period,” Dr. Ravussin summarized, “because, 10 years ago, nobody thought that [results with] pharmacotherapy can approach bariatric surgery. Now we have other drugs that are still in development that are going to approach really close bariatric surgery.”

In an email to this news organization, Dr. Sarma noted that “due to the potent weight loss and glycemic benefits of GLP-1 agonists, patients who wish to avoid the risks of bariatric surgery may wish to discuss the option of medical therapy with their health professionals.”

“For next steps,” she said, “we need long-term studies comparing the weight-lowering, glycemic, and cardiovascular benefits of GLP-1 agonists in comparison to bariatric surgery for better counseling in obesity treatment.”

Three RCTs, three observational studies

The researchers searched the literature for randomized controlled trials (RCTs) and observational studies up to April 21, 2021, which directly compared absolute weight loss with a GLP-1 agonist – liraglutide, dulaglutide, semaglutide, exenatide, lixisenatide, and albiglutide (which are approved by the U.S. Food and Drug Administration or Health Canada) – versus any type of bariatric surgery including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, gastric banding, and biliopancreatic diversion.

The studies included patients aged 18 and older with a body mass index (BMI) greater than 25 kg/m².   

Secondary outcomes included change in BMI, and for patients with type 2 diabetes, change in A1c. 

The researchers identified three RCTs and three observational studies, with diverse drugs and diverse types of bariatric surgery, which enrolled 13 to 134 patients, with follow-up from 6 months to 10 years.

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

SAN DIEGO – In a review and meta-analysis of six small, head-to-head studies of bariatric surgery versus subcutaneous injection with a glucagon-like peptide-1 (GLP-1) agonist, weight loss was greater after the surgery, but glycemic control was similar after either treatment.

However, researchers have yet to directly compare bariatric surgery with new dual and even triple agonists that are in development.

The review by Shohinee Sarma, MD, MPH, and Patricia Palcu, MD, from the University of Toronto, was published  in Obesity. Dr. Sarma also presented the findings virtually at the Obesity journal symposium at ObesityWeek® 2022.

Eric Ravussin, PhD, outgoing editor-in-chief of Obesity, explained to in an interview that this is one of five articles the editors chose from about 20 papers submitted for consideration for the symposium, and it was selected because it is a first review and meta-analysis of this direct comparison.

It showed that in “a straight head-to-head comparison, weight loss is larger by about 20 kg (44 lb) with bariatric surgery versus a GLP-1 agonist, but the improvement in glycemia (carbohydrate metabolism) was similar,” said Dr. Ravussin, from Pennington Biomedical Research Center, Louisiana State University, Baton Rouge.

Study limitations, which the authors also acknowledge, include that this was a small review of small studies: There were only six studies and 322 patients.

Moreover, the data are from 2007 to 2017, and newer weight-loss drugs are more potent.

Most studies in the review compared bariatric surgery with liraglutide, Dr. Ravussin noted, whereas, “we have now better GLP-1 agonists like semaglutide,” as well as drugs that are combinations of a GLP-1 agonist with another agonist or agonists.

“Tirzepatide, for example, which is a combination of a GLP-1 agonist and a [glucose-dependent insulinotropic polypeptide (GIP) agonist], is showing results that are very close to weight loss with bariatric surgery,” he observed.

There are quite a few other drugs in development, too, he continued, which are going to approach the weight loss obtained with bariatric surgery.

Novo Nordisk is coming out with a combination of an amylin analog (cagrilintide) and a GLP-1 agonist (semaglutide), he noted. “There are others coming in with GLP-1 and glucagon [dual agonists], and there is even a ... combo called triple G, which is a glucagon, GLP-1, and GIP [agonist].”

We now need a head-to-head comparison between bariatric surgery versus a combination drug like tirzepatide in a large population, he said.

“This is an exciting period,” Dr. Ravussin summarized, “because, 10 years ago, nobody thought that [results with] pharmacotherapy can approach bariatric surgery. Now we have other drugs that are still in development that are going to approach really close bariatric surgery.”

In an email to this news organization, Dr. Sarma noted that “due to the potent weight loss and glycemic benefits of GLP-1 agonists, patients who wish to avoid the risks of bariatric surgery may wish to discuss the option of medical therapy with their health professionals.”

“For next steps,” she said, “we need long-term studies comparing the weight-lowering, glycemic, and cardiovascular benefits of GLP-1 agonists in comparison to bariatric surgery for better counseling in obesity treatment.”

Three RCTs, three observational studies

The researchers searched the literature for randomized controlled trials (RCTs) and observational studies up to April 21, 2021, which directly compared absolute weight loss with a GLP-1 agonist – liraglutide, dulaglutide, semaglutide, exenatide, lixisenatide, and albiglutide (which are approved by the U.S. Food and Drug Administration or Health Canada) – versus any type of bariatric surgery including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, gastric banding, and biliopancreatic diversion.

The studies included patients aged 18 and older with a body mass index (BMI) greater than 25 kg/m².   

Secondary outcomes included change in BMI, and for patients with type 2 diabetes, change in A1c. 

The researchers identified three RCTs and three observational studies, with diverse drugs and diverse types of bariatric surgery, which enrolled 13 to 134 patients, with follow-up from 6 months to 10 years.

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

SAN DIEGO – In a review and meta-analysis of six small, head-to-head studies of bariatric surgery versus subcutaneous injection with a glucagon-like peptide-1 (GLP-1) agonist, weight loss was greater after the surgery, but glycemic control was similar after either treatment.

However, researchers have yet to directly compare bariatric surgery with new dual and even triple agonists that are in development.

The review by Shohinee Sarma, MD, MPH, and Patricia Palcu, MD, from the University of Toronto, was published  in Obesity. Dr. Sarma also presented the findings virtually at the Obesity journal symposium at ObesityWeek® 2022.

Eric Ravussin, PhD, outgoing editor-in-chief of Obesity, explained to in an interview that this is one of five articles the editors chose from about 20 papers submitted for consideration for the symposium, and it was selected because it is a first review and meta-analysis of this direct comparison.

It showed that in “a straight head-to-head comparison, weight loss is larger by about 20 kg (44 lb) with bariatric surgery versus a GLP-1 agonist, but the improvement in glycemia (carbohydrate metabolism) was similar,” said Dr. Ravussin, from Pennington Biomedical Research Center, Louisiana State University, Baton Rouge.

Study limitations, which the authors also acknowledge, include that this was a small review of small studies: There were only six studies and 322 patients.

Moreover, the data are from 2007 to 2017, and newer weight-loss drugs are more potent.

Most studies in the review compared bariatric surgery with liraglutide, Dr. Ravussin noted, whereas, “we have now better GLP-1 agonists like semaglutide,” as well as drugs that are combinations of a GLP-1 agonist with another agonist or agonists.

“Tirzepatide, for example, which is a combination of a GLP-1 agonist and a [glucose-dependent insulinotropic polypeptide (GIP) agonist], is showing results that are very close to weight loss with bariatric surgery,” he observed.

There are quite a few other drugs in development, too, he continued, which are going to approach the weight loss obtained with bariatric surgery.

Novo Nordisk is coming out with a combination of an amylin analog (cagrilintide) and a GLP-1 agonist (semaglutide), he noted. “There are others coming in with GLP-1 and glucagon [dual agonists], and there is even a ... combo called triple G, which is a glucagon, GLP-1, and GIP [agonist].”

We now need a head-to-head comparison between bariatric surgery versus a combination drug like tirzepatide in a large population, he said.

“This is an exciting period,” Dr. Ravussin summarized, “because, 10 years ago, nobody thought that [results with] pharmacotherapy can approach bariatric surgery. Now we have other drugs that are still in development that are going to approach really close bariatric surgery.”

In an email to this news organization, Dr. Sarma noted that “due to the potent weight loss and glycemic benefits of GLP-1 agonists, patients who wish to avoid the risks of bariatric surgery may wish to discuss the option of medical therapy with their health professionals.”

“For next steps,” she said, “we need long-term studies comparing the weight-lowering, glycemic, and cardiovascular benefits of GLP-1 agonists in comparison to bariatric surgery for better counseling in obesity treatment.”

Three RCTs, three observational studies

The researchers searched the literature for randomized controlled trials (RCTs) and observational studies up to April 21, 2021, which directly compared absolute weight loss with a GLP-1 agonist – liraglutide, dulaglutide, semaglutide, exenatide, lixisenatide, and albiglutide (which are approved by the U.S. Food and Drug Administration or Health Canada) – versus any type of bariatric surgery including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy, gastric banding, and biliopancreatic diversion.

The studies included patients aged 18 and older with a body mass index (BMI) greater than 25 kg/m².   

Secondary outcomes included change in BMI, and for patients with type 2 diabetes, change in A1c. 

The researchers identified three RCTs and three observational studies, with diverse drugs and diverse types of bariatric surgery, which enrolled 13 to 134 patients, with follow-up from 6 months to 10 years.

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

Five pounds of weight gain during the holidays is a disproven myth that pops up annually like holiday lights. But before you do a happy dance and pile that extra whipped cream on your pie, you should know two things. One, people do gain weight during the holidays. Two, the extra pounds tend to stick around because most people never lose their holiday weight. Over time, these extra pounds can lead to obesity and weight-related conditions such as diabetes and hypertension.

Let’s be clear. Your weight is one of many markers of your wellness and metabolic health. However, weight changes can indicate that your health is off balance. Holiday weight gain often comes from indulging in increased rich foods, less physical activity, higher stress levels, and sleep disruption.

Courtesy Jason Weil Photography

Optimizing lifestyle factors and trying to lose weight is challenging any time of the year. However, the holiday bustle makes losing weight during this time even more challenging for most people. But maintaining your weight and overall wellness is manageable with three simple shifts in mindset, mindful eating, and meal strategy. Let’s discuss each.
 

Mindset 

From personal and professional experience, I see two primary attitudes regarding holiday eating. They are either “I’ll wait till January to go on a diet” or “I’m on a diet, so I can’t eat anything I like during the holidays.” Both attitude extremes prevent enjoyable and healthy eating during the holidays because they place the focus on food. With both mindsets, food is in control, which leaves you feeling out of control. Rather than having an “all or none” mindset during the holidays, I encourage you to ask yourself:

• “What matters most to me during the holidays?” In a recent survey, 72% of Americans said they look forward to  during the holidays. Although food often accompanies family celebrations, it’s the time with family that matters most. Choose to savor sweet time spent with loved ones instead of stuffing yourself with excess sugary sweets.
• “How can I enjoy myself without food or alcoholic beverages?” So often, we eat or drink certain foods out of habit. Shift your mindset from “we always do this” to “what could we do instead?” Asking this question may be the doorway to creating new, non–food-centered traditions.
• “How can I have the foods I love during the holidays and still meet my weight and wellness goals?” This question helps you create opportunities instead of depriving yourself. Rather than depriving yourself, you could cut back on snacking or reduce your sugar intake elsewhere. Or add an extra workout session or stress reduction practice during the holidays.

Mindful eating 

The purpose of mindful eating isn’t weight loss. Some studies suggest it may help maintain weight. More importantly, mindfulness can improve your relationship with food and promote wellness. Traditional tips for mindful eating include doing the following as you eat: Being present in the moment, not judging your food, slowing down, and savoring the taste of your food. During the holidays, asking additional questions may enhance mindful eating. For instance:

• “Am I eating to avoid uncomfortable emotions?” The holidays can trigger emotions such as grief, sadness, and anxiety. Also, preexisting can worsen. Decadent foods become a quick fix leading to more emotional eating during this season. Addressing these emotions can help you avoid overeating during the holidays. For mental health resources, visit the 
• “What food or drink do I most enjoy during the holidays?” Trying to resist your favorite holiday treats can be an exhausting test of “willpower.” Eventually,  and psychological reasons, and you “cheat” on your plan to not eat holiday treats. To prevent this painful battle of treat versus cheat, plan to eat your “indulgence food” in moderation. Savor the foods you enjoy. Then cut out the rest of the food you don’t like or feel you must eat because “Aunty Sarah will feel bad.”

Meal strategy

Many holiday treats and parties are unavoidable unless you plan to hide in a cave for the next few weeks. Rather than torturing yourself nibbling on celery and sipping on sparkling water during your holiday event, create a strategy. For 8 years, I’ve been on my weight loss and wellness journey. I have a holiday strategy that helps my patients, clients, and me maintain our weight and wellness during the holidays. One critical part of the strategy is to anticipate indulgence events. Specifically, look at all the planned holiday events and choose three indulgence events. The rest of the time, do your best to stay on your plan. Knowing your indulgence events to look forward to gives you a sense of control over when you indulge. On non-indulgent days, think, “I can eat it but choose not to” instead of the limiting thought, “I can’t eat that.” Choice is a powerful tool. Once at an indulgence event, I focus on mindful eating and enjoying people around me, which cuts down on overeating just because “I can.”

This holiday season is a reunion time for many people, after enduring long separations from family and friends due to the pandemic. Relishing time with loved ones should be your focus during the holidays – not eating yourself into worse health or worrying about dieting. Even if you choose not to make all the shifts in mindset, mindful eating, and meal strategy mentioned, choosing even one change to focus on can help you both enjoy the holidays and have increased control over your weight and wellness. Whatever you do, may you and your loved ones have a safe, healthy, and enjoyable holiday season.

Sylvia Gonsahn-Bollie, MD, DipABOM, is an integrative obesity specialist who specializes in individualized solutions for emotional and biological overeating. She is CEO and lead physician at Embrace You Weight and Wellness, Telehealth & Virtual Counseling. She has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.

Five pounds of weight gain during the holidays is a disproven myth that pops up annually like holiday lights. But before you do a happy dance and pile that extra whipped cream on your pie, you should know two things. One, people do gain weight during the holidays. Two, the extra pounds tend to stick around because most people never lose their holiday weight. Over time, these extra pounds can lead to obesity and weight-related conditions such as diabetes and hypertension.

Let’s be clear. Your weight is one of many markers of your wellness and metabolic health. However, weight changes can indicate that your health is off balance. Holiday weight gain often comes from indulging in increased rich foods, less physical activity, higher stress levels, and sleep disruption.

Courtesy Jason Weil Photography

Optimizing lifestyle factors and trying to lose weight is challenging any time of the year. However, the holiday bustle makes losing weight during this time even more challenging for most people. But maintaining your weight and overall wellness is manageable with three simple shifts in mindset, mindful eating, and meal strategy. Let’s discuss each.
 

Mindset 

From personal and professional experience, I see two primary attitudes regarding holiday eating. They are either “I’ll wait till January to go on a diet” or “I’m on a diet, so I can’t eat anything I like during the holidays.” Both attitude extremes prevent enjoyable and healthy eating during the holidays because they place the focus on food. With both mindsets, food is in control, which leaves you feeling out of control. Rather than having an “all or none” mindset during the holidays, I encourage you to ask yourself:

• “What matters most to me during the holidays?” In a recent survey, 72% of Americans said they look forward to  during the holidays. Although food often accompanies family celebrations, it’s the time with family that matters most. Choose to savor sweet time spent with loved ones instead of stuffing yourself with excess sugary sweets.
• “How can I enjoy myself without food or alcoholic beverages?” So often, we eat or drink certain foods out of habit. Shift your mindset from “we always do this” to “what could we do instead?” Asking this question may be the doorway to creating new, non–food-centered traditions.
• “How can I have the foods I love during the holidays and still meet my weight and wellness goals?” This question helps you create opportunities instead of depriving yourself. Rather than depriving yourself, you could cut back on snacking or reduce your sugar intake elsewhere. Or add an extra workout session or stress reduction practice during the holidays.

Mindful eating 

The purpose of mindful eating isn’t weight loss. Some studies suggest it may help maintain weight. More importantly, mindfulness can improve your relationship with food and promote wellness. Traditional tips for mindful eating include doing the following as you eat: Being present in the moment, not judging your food, slowing down, and savoring the taste of your food. During the holidays, asking additional questions may enhance mindful eating. For instance:

• “Am I eating to avoid uncomfortable emotions?” The holidays can trigger emotions such as grief, sadness, and anxiety. Also, preexisting can worsen. Decadent foods become a quick fix leading to more emotional eating during this season. Addressing these emotions can help you avoid overeating during the holidays. For mental health resources, visit the 
• “What food or drink do I most enjoy during the holidays?” Trying to resist your favorite holiday treats can be an exhausting test of “willpower.” Eventually,  and psychological reasons, and you “cheat” on your plan to not eat holiday treats. To prevent this painful battle of treat versus cheat, plan to eat your “indulgence food” in moderation. Savor the foods you enjoy. Then cut out the rest of the food you don’t like or feel you must eat because “Aunty Sarah will feel bad.”

Meal strategy

Many holiday treats and parties are unavoidable unless you plan to hide in a cave for the next few weeks. Rather than torturing yourself nibbling on celery and sipping on sparkling water during your holiday event, create a strategy. For 8 years, I’ve been on my weight loss and wellness journey. I have a holiday strategy that helps my patients, clients, and me maintain our weight and wellness during the holidays. One critical part of the strategy is to anticipate indulgence events. Specifically, look at all the planned holiday events and choose three indulgence events. The rest of the time, do your best to stay on your plan. Knowing your indulgence events to look forward to gives you a sense of control over when you indulge. On non-indulgent days, think, “I can eat it but choose not to” instead of the limiting thought, “I can’t eat that.” Choice is a powerful tool. Once at an indulgence event, I focus on mindful eating and enjoying people around me, which cuts down on overeating just because “I can.”

This holiday season is a reunion time for many people, after enduring long separations from family and friends due to the pandemic. Relishing time with loved ones should be your focus during the holidays – not eating yourself into worse health or worrying about dieting. Even if you choose not to make all the shifts in mindset, mindful eating, and meal strategy mentioned, choosing even one change to focus on can help you both enjoy the holidays and have increased control over your weight and wellness. Whatever you do, may you and your loved ones have a safe, healthy, and enjoyable holiday season.

Sylvia Gonsahn-Bollie, MD, DipABOM, is an integrative obesity specialist who specializes in individualized solutions for emotional and biological overeating. She is CEO and lead physician at Embrace You Weight and Wellness, Telehealth & Virtual Counseling. She has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.

Five pounds of weight gain during the holidays is a disproven myth that pops up annually like holiday lights. But before you do a happy dance and pile that extra whipped cream on your pie, you should know two things. One, people do gain weight during the holidays. Two, the extra pounds tend to stick around because most people never lose their holiday weight. Over time, these extra pounds can lead to obesity and weight-related conditions such as diabetes and hypertension.

Let’s be clear. Your weight is one of many markers of your wellness and metabolic health. However, weight changes can indicate that your health is off balance. Holiday weight gain often comes from indulging in increased rich foods, less physical activity, higher stress levels, and sleep disruption.

Courtesy Jason Weil Photography

Optimizing lifestyle factors and trying to lose weight is challenging any time of the year. However, the holiday bustle makes losing weight during this time even more challenging for most people. But maintaining your weight and overall wellness is manageable with three simple shifts in mindset, mindful eating, and meal strategy. Let’s discuss each.
 

Mindset 

From personal and professional experience, I see two primary attitudes regarding holiday eating. They are either “I’ll wait till January to go on a diet” or “I’m on a diet, so I can’t eat anything I like during the holidays.” Both attitude extremes prevent enjoyable and healthy eating during the holidays because they place the focus on food. With both mindsets, food is in control, which leaves you feeling out of control. Rather than having an “all or none” mindset during the holidays, I encourage you to ask yourself:

• “What matters most to me during the holidays?” In a recent survey, 72% of Americans said they look forward to  during the holidays. Although food often accompanies family celebrations, it’s the time with family that matters most. Choose to savor sweet time spent with loved ones instead of stuffing yourself with excess sugary sweets.
• “How can I enjoy myself without food or alcoholic beverages?” So often, we eat or drink certain foods out of habit. Shift your mindset from “we always do this” to “what could we do instead?” Asking this question may be the doorway to creating new, non–food-centered traditions.
• “How can I have the foods I love during the holidays and still meet my weight and wellness goals?” This question helps you create opportunities instead of depriving yourself. Rather than depriving yourself, you could cut back on snacking or reduce your sugar intake elsewhere. Or add an extra workout session or stress reduction practice during the holidays.

Mindful eating 

The purpose of mindful eating isn’t weight loss. Some studies suggest it may help maintain weight. More importantly, mindfulness can improve your relationship with food and promote wellness. Traditional tips for mindful eating include doing the following as you eat: Being present in the moment, not judging your food, slowing down, and savoring the taste of your food. During the holidays, asking additional questions may enhance mindful eating. For instance:

• “Am I eating to avoid uncomfortable emotions?” The holidays can trigger emotions such as grief, sadness, and anxiety. Also, preexisting can worsen. Decadent foods become a quick fix leading to more emotional eating during this season. Addressing these emotions can help you avoid overeating during the holidays. For mental health resources, visit the 
• “What food or drink do I most enjoy during the holidays?” Trying to resist your favorite holiday treats can be an exhausting test of “willpower.” Eventually,  and psychological reasons, and you “cheat” on your plan to not eat holiday treats. To prevent this painful battle of treat versus cheat, plan to eat your “indulgence food” in moderation. Savor the foods you enjoy. Then cut out the rest of the food you don’t like or feel you must eat because “Aunty Sarah will feel bad.”

Meal strategy

Many holiday treats and parties are unavoidable unless you plan to hide in a cave for the next few weeks. Rather than torturing yourself nibbling on celery and sipping on sparkling water during your holiday event, create a strategy. For 8 years, I’ve been on my weight loss and wellness journey. I have a holiday strategy that helps my patients, clients, and me maintain our weight and wellness during the holidays. One critical part of the strategy is to anticipate indulgence events. Specifically, look at all the planned holiday events and choose three indulgence events. The rest of the time, do your best to stay on your plan. Knowing your indulgence events to look forward to gives you a sense of control over when you indulge. On non-indulgent days, think, “I can eat it but choose not to” instead of the limiting thought, “I can’t eat that.” Choice is a powerful tool. Once at an indulgence event, I focus on mindful eating and enjoying people around me, which cuts down on overeating just because “I can.”

This holiday season is a reunion time for many people, after enduring long separations from family and friends due to the pandemic. Relishing time with loved ones should be your focus during the holidays – not eating yourself into worse health or worrying about dieting. Even if you choose not to make all the shifts in mindset, mindful eating, and meal strategy mentioned, choosing even one change to focus on can help you both enjoy the holidays and have increased control over your weight and wellness. Whatever you do, may you and your loved ones have a safe, healthy, and enjoyable holiday season.

Sylvia Gonsahn-Bollie, MD, DipABOM, is an integrative obesity specialist who specializes in individualized solutions for emotional and biological overeating. She is CEO and lead physician at Embrace You Weight and Wellness, Telehealth & Virtual Counseling. She has disclosed having no relevant financial relationships. A version of this article first appeared on Medscape.com.