Clinical Endocrinology News

TOPLINE:

The inclusion of sugar-substitute sweeteners and sweetness enhancers in a sugar-reduced maintenance diet following weight loss improves weight maintenance as well as well-being in adults, with no increases in type 2 diabetes or cardiovascular disease risk compared with a diet excluding the sweeteners, a randomized trial showed.

The study also showed that among overweight or obese children, greater reductions in uncontrolled eating were observed among those receiving the sweeteners.

The findings counter previous reports that raised concerns about the non-sugar sweeteners, including recent research from the World Health Organization suggesting no benefits in weight control and a possible increase in the risk for type 2 diabetes or cardiovascular disease with the sweeteners.

METHODOLOGY:

• The findings are from an exploratory analysis of the multicenter, randomized SWEET trial.
• The trial involved 341 adults with overweight or obesity (aged 18-65 years, 71% women, body mass index [BMI] ≥ 25) and 38 children with overweight (aged 6-12 years, 60% girls, BMI-for-age > 85th percentile), recruited in Denmark, Spain, Greece, and the Netherlands through webpages, social media, newspapers, and registries.
• For the first 2 months of the trial, adults were instructed to follow a low-energy diet (the Cambridge Weight Plan) with the goal of achieving at least 5% weight loss, while children received dietary advice to maintain body weight.
• In the subsequent 10 months, adults as well as children were randomized to healthy diets that either consisted of less than 10% of calories from added sugar but permitted foods and drinks with sweeteners and sweetness enhancers, or the same diet but not allowing the use of the sweeteners or sweetness enhancers.
• Participants had weight, BMI, anthropometry, and risk markers for type 2 diabetes and cardiovascular disease monitored at the trial’s baseline, as well as at 2, 6, and 12 months.
• In addition, participants completed food frequency questionnaires and provided urine samples to assess biomarkers of the sweeteners, fructose and sucrose, in order to measure compliance with the dietary instructions.

TAKEAWAY:

• While the sweetener and non-sweetener groups both had decreases in consumption of products high in sugar, the reduction was significantly higher in the group that allowed use of the sweeteners (P = .002).
• In the intention-to-treat analyses, adults (n = 277) permitted sweeteners showed a small but significantly greater weight loss maintenance after 1 year than the non-sweetener group (average weight loss, 7.2 kg vs 5.6 kg; P = .029).
• Among 203 participants who completed the trial, there were no differences between the groups in terms of markers for type 2 diabetes and cardiovascular disease.
• There were also no differences between the groups in terms of subjective appetite sensations and appetite hormones in a subgroup of 104 patients.
• In an analysis of 22 children who completed the study, there were no differences in BMI-for-age z scores between sweetener and non-sweetener groups.
• In terms of effects on eating behavior, adults in the sweetener group reported greater diet satisfaction when eating out (P = .03), increased positive mood (P = .013), and reduced craving for sweet food (P = .034) at 6 months than in the non-sweetener group.
• Conversely, those receiving no sweeteners had a greater liking bias for sweet vs savory foods at 6 months (P = .023) and 12 months (P = .005).
• There were no differences between the groups in reported physical activity or quality of life.
• However, among children with higher uncontrolled eating scores at baseline, the uncontrolled eating scores at 12 months were significantly lower among children who were allowed the sugar-substitute sweeteners vs the non-sweetener children (P = .021).

IN PRACTICE:

“Our findings suggest that the inclusion of low/no energy-sweetened products may benefit children who show high levels of uncontrolled eating,” said the study’s co-lead author, Clarissa Dakin, of the Appetite Control and Energy Balance Research Group at the University of Leeds, Leeds, England, in a press statement.

“Together, these findings provide important insights for the ongoing reevaluation of food additive sweeteners by the European Food Safety Authority and other health agencies worldwide,” she said.

Coauthor Jason Halford, head of the School of Psychology at the University of Leeds, added in the press statement that “the use of low-calorie sweeteners in weight management has been questioned, in part because of the link between their use and apparent weight gain in observational studies.”

“However, increasingly, it is becoming apparent that is not the case in long-term studies,” said a study co-author in a press statement.”

SOURCE:

The findings from the two abstracts will be presented in May at the European Association for the Study of Obesity. The study abstracts were issued in advance.

LIMITATIONS:

Some of the results, particularly in children’s subgroups, were limited by the relatively low number of children, underscoring the need for future studies on the issue, the authors noted.

DISCLOSURES:

Dr. Halford has received research funding from the American Beverage Association.

A version of this article appeared on Medscape.com.

TOPLINE:

The inclusion of sugar-substitute sweeteners and sweetness enhancers in a sugar-reduced maintenance diet following weight loss improves weight maintenance as well as well-being in adults, with no increases in type 2 diabetes or cardiovascular disease risk compared with a diet excluding the sweeteners, a randomized trial showed.

The study also showed that among overweight or obese children, greater reductions in uncontrolled eating were observed among those receiving the sweeteners.

The findings counter previous reports that raised concerns about the non-sugar sweeteners, including recent research from the World Health Organization suggesting no benefits in weight control and a possible increase in the risk for type 2 diabetes or cardiovascular disease with the sweeteners.

METHODOLOGY:

• The findings are from an exploratory analysis of the multicenter, randomized SWEET trial.
• The trial involved 341 adults with overweight or obesity (aged 18-65 years, 71% women, body mass index [BMI] ≥ 25) and 38 children with overweight (aged 6-12 years, 60% girls, BMI-for-age > 85th percentile), recruited in Denmark, Spain, Greece, and the Netherlands through webpages, social media, newspapers, and registries.
• For the first 2 months of the trial, adults were instructed to follow a low-energy diet (the Cambridge Weight Plan) with the goal of achieving at least 5% weight loss, while children received dietary advice to maintain body weight.
• In the subsequent 10 months, adults as well as children were randomized to healthy diets that either consisted of less than 10% of calories from added sugar but permitted foods and drinks with sweeteners and sweetness enhancers, or the same diet but not allowing the use of the sweeteners or sweetness enhancers.
• Participants had weight, BMI, anthropometry, and risk markers for type 2 diabetes and cardiovascular disease monitored at the trial’s baseline, as well as at 2, 6, and 12 months.
• In addition, participants completed food frequency questionnaires and provided urine samples to assess biomarkers of the sweeteners, fructose and sucrose, in order to measure compliance with the dietary instructions.

TAKEAWAY:

• While the sweetener and non-sweetener groups both had decreases in consumption of products high in sugar, the reduction was significantly higher in the group that allowed use of the sweeteners (P = .002).
• In the intention-to-treat analyses, adults (n = 277) permitted sweeteners showed a small but significantly greater weight loss maintenance after 1 year than the non-sweetener group (average weight loss, 7.2 kg vs 5.6 kg; P = .029).
• Among 203 participants who completed the trial, there were no differences between the groups in terms of markers for type 2 diabetes and cardiovascular disease.
• There were also no differences between the groups in terms of subjective appetite sensations and appetite hormones in a subgroup of 104 patients.
• In an analysis of 22 children who completed the study, there were no differences in BMI-for-age z scores between sweetener and non-sweetener groups.
• In terms of effects on eating behavior, adults in the sweetener group reported greater diet satisfaction when eating out (P = .03), increased positive mood (P = .013), and reduced craving for sweet food (P = .034) at 6 months than in the non-sweetener group.
• Conversely, those receiving no sweeteners had a greater liking bias for sweet vs savory foods at 6 months (P = .023) and 12 months (P = .005).
• There were no differences between the groups in reported physical activity or quality of life.
• However, among children with higher uncontrolled eating scores at baseline, the uncontrolled eating scores at 12 months were significantly lower among children who were allowed the sugar-substitute sweeteners vs the non-sweetener children (P = .021).

IN PRACTICE:

“Our findings suggest that the inclusion of low/no energy-sweetened products may benefit children who show high levels of uncontrolled eating,” said the study’s co-lead author, Clarissa Dakin, of the Appetite Control and Energy Balance Research Group at the University of Leeds, Leeds, England, in a press statement.

“Together, these findings provide important insights for the ongoing reevaluation of food additive sweeteners by the European Food Safety Authority and other health agencies worldwide,” she said.

Coauthor Jason Halford, head of the School of Psychology at the University of Leeds, added in the press statement that “the use of low-calorie sweeteners in weight management has been questioned, in part because of the link between their use and apparent weight gain in observational studies.”

“However, increasingly, it is becoming apparent that is not the case in long-term studies,” said a study co-author in a press statement.”

SOURCE:

The findings from the two abstracts will be presented in May at the European Association for the Study of Obesity. The study abstracts were issued in advance.

LIMITATIONS:

Some of the results, particularly in children’s subgroups, were limited by the relatively low number of children, underscoring the need for future studies on the issue, the authors noted.

DISCLOSURES:

Dr. Halford has received research funding from the American Beverage Association.

A version of this article appeared on Medscape.com.

TOPLINE:

The inclusion of sugar-substitute sweeteners and sweetness enhancers in a sugar-reduced maintenance diet following weight loss improves weight maintenance as well as well-being in adults, with no increases in type 2 diabetes or cardiovascular disease risk compared with a diet excluding the sweeteners, a randomized trial showed.

The study also showed that among overweight or obese children, greater reductions in uncontrolled eating were observed among those receiving the sweeteners.

The findings counter previous reports that raised concerns about the non-sugar sweeteners, including recent research from the World Health Organization suggesting no benefits in weight control and a possible increase in the risk for type 2 diabetes or cardiovascular disease with the sweeteners.

METHODOLOGY:

• The findings are from an exploratory analysis of the multicenter, randomized SWEET trial.
• The trial involved 341 adults with overweight or obesity (aged 18-65 years, 71% women, body mass index [BMI] ≥ 25) and 38 children with overweight (aged 6-12 years, 60% girls, BMI-for-age > 85th percentile), recruited in Denmark, Spain, Greece, and the Netherlands through webpages, social media, newspapers, and registries.
• For the first 2 months of the trial, adults were instructed to follow a low-energy diet (the Cambridge Weight Plan) with the goal of achieving at least 5% weight loss, while children received dietary advice to maintain body weight.
• In the subsequent 10 months, adults as well as children were randomized to healthy diets that either consisted of less than 10% of calories from added sugar but permitted foods and drinks with sweeteners and sweetness enhancers, or the same diet but not allowing the use of the sweeteners or sweetness enhancers.
• Participants had weight, BMI, anthropometry, and risk markers for type 2 diabetes and cardiovascular disease monitored at the trial’s baseline, as well as at 2, 6, and 12 months.
• In addition, participants completed food frequency questionnaires and provided urine samples to assess biomarkers of the sweeteners, fructose and sucrose, in order to measure compliance with the dietary instructions.

TAKEAWAY:

• While the sweetener and non-sweetener groups both had decreases in consumption of products high in sugar, the reduction was significantly higher in the group that allowed use of the sweeteners (P = .002).
• In the intention-to-treat analyses, adults (n = 277) permitted sweeteners showed a small but significantly greater weight loss maintenance after 1 year than the non-sweetener group (average weight loss, 7.2 kg vs 5.6 kg; P = .029).
• Among 203 participants who completed the trial, there were no differences between the groups in terms of markers for type 2 diabetes and cardiovascular disease.
• There were also no differences between the groups in terms of subjective appetite sensations and appetite hormones in a subgroup of 104 patients.
• In an analysis of 22 children who completed the study, there were no differences in BMI-for-age z scores between sweetener and non-sweetener groups.
• In terms of effects on eating behavior, adults in the sweetener group reported greater diet satisfaction when eating out (P = .03), increased positive mood (P = .013), and reduced craving for sweet food (P = .034) at 6 months than in the non-sweetener group.
• Conversely, those receiving no sweeteners had a greater liking bias for sweet vs savory foods at 6 months (P = .023) and 12 months (P = .005).
• There were no differences between the groups in reported physical activity or quality of life.
• However, among children with higher uncontrolled eating scores at baseline, the uncontrolled eating scores at 12 months were significantly lower among children who were allowed the sugar-substitute sweeteners vs the non-sweetener children (P = .021).

IN PRACTICE:

“Our findings suggest that the inclusion of low/no energy-sweetened products may benefit children who show high levels of uncontrolled eating,” said the study’s co-lead author, Clarissa Dakin, of the Appetite Control and Energy Balance Research Group at the University of Leeds, Leeds, England, in a press statement.

“Together, these findings provide important insights for the ongoing reevaluation of food additive sweeteners by the European Food Safety Authority and other health agencies worldwide,” she said.

Coauthor Jason Halford, head of the School of Psychology at the University of Leeds, added in the press statement that “the use of low-calorie sweeteners in weight management has been questioned, in part because of the link between their use and apparent weight gain in observational studies.”

“However, increasingly, it is becoming apparent that is not the case in long-term studies,” said a study co-author in a press statement.”

SOURCE:

The findings from the two abstracts will be presented in May at the European Association for the Study of Obesity. The study abstracts were issued in advance.

LIMITATIONS:

Some of the results, particularly in children’s subgroups, were limited by the relatively low number of children, underscoring the need for future studies on the issue, the authors noted.

DISCLOSURES:

Dr. Halford has received research funding from the American Beverage Association.

A version of this article appeared on Medscape.com.

As a cardiologist specializing in obesity medicine, I often encounter patients who would greatly benefit from the new generation of weight loss drugs that work as glucagon-like peptide 1 (GLP-1) agonists. In the recently published SELECT trial results, for example, semaglutide (marketed by Novo Nordisk as Wegovy for weight loss and Ozempic for type 2 diabetes) demonstrated a 20% risk reduction of heart attacks and strokes in overweight and obese individuals without diabetes and with cardiovascular disease, establishing it as a cardiovascular disease–modifying medication in people without type 2 diabetes.

Unfortunately, the high demand for these new weight loss medications has resulted in a frustrating, long-lasting shortage. The manufacturers of the two FDA-approved drugs, Novo Nordisk and Eli Lilly (tirzepatide, marketed as Zepbound for weight loss and Mounjaro for type 2 diabetes), are struggling to meet the overwhelming need.

To ensure continuation of patient care, federal law allows compounding pharmacies to make “essentially a copy” of the medications that are listed as “currently in shortage” on the US Food and Drug Administration (FDA) drug shortage list. Both semaglutide and tirzepatide are on that list. For Americans who suffer from obesity and other weight-related diseases, these drugs could be a lifeline.

Despite this, the medical community has broadly criticized the utilization of compounded GLP-1 agonists, even those obtained from reputable and legitimate compounding pharmacies.

Yes, high demand has led to the emergence of unregulated companies and scammers producing substandard or counterfeit versions of these medications.

The FDA has found fraudulent products (masquerading as the weight loss drugs) and has issued warning letters to stop the distribution of illegally marketed semaglutide. “These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients,” it cautions. Some products use a similar-sounding semaglutide sodium salt, which has uncertain safety and efficacy, and had generated warnings from the FDA and state boards of pharmacy.

Many of these products are marketed directly to consumers online through websites and social media, with little to no medical oversight. This practice is a significant concern, as it may affect patient safety, and should be discouraged.

However, according to a statement from the Alliance for Pharmacy Compounding (APC), legitimate compounding pharmacies aren’t the ones selling these dubious products on the black market, particularly online. This illegal practice has garnered media attention and is sometimes incorrectly associated with legitimate pharmacy compounding.

In contrast, legal and certified versions of GLP-1 agonist medications can be obtained from well-regulated and reputable compounding pharmacies. These pharmacies must adhere to all federal and state regulations and dispense medications only with a valid prescription from a licensed physician.

Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products.

There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs.

In the face of this Wild West climate, where compounded drugs may vary in their source, formulation, potency, and purity, The Obesity Society, the Obesity Medical Association, and the Obesity Action Coalition published a joint statement that advised against the use of compounded GLP-1 agonists, citing safety concerns and lack of regulatory oversight.

This stance, while aimed at ensuring patient safety, inadvertently raises a critical issue.

By completely dismissing compounded medications, experts may unintentionally bolster the black market and overlook the needs of patients who could benefit from these medications, contrary to the intentions of the exemption provided in federal law for compounding during a drug shortage. In fact, the presence of unreliable suppliers highlights the need to direct the public toward trustworthy sources, rather than imposing a total ban on medically appropriate alternatives.

The joint statement calls compounded GLP-1 agonists “counterfeit.” This inaccurate overgeneralization probably stems from a misunderstanding of the compounding process and its regulations. Legitimate and regulated pharmacies compound base GLP-1 agonists, which are “essentially a copy” of FDA-approved medications, not counterfeits. Recognizing this is crucial for maintaining trust in both compounding pharmacies and regulatory bodies.

It is correct that “the only FDA-approved manufacturers of these medications are the companies that created the active pharmaceutical ingredients — Novo Nordisk and Eli Lilly,” but the joint statement fails to mention the exemptions provided by law that allow compounding copies of the branded medications if they are on the shortage list.

Compounding pharmacies must obtain active pharmaceutical ingredients (APIs) from FDA-registered facilities, which are required to adhere to Current Good Manufacturing Practices (cGMP). This ensures the APIs’ quality, potency, and purity, crucial for the safety and efficacy of compounded medications.

Compounded drugs are not FDA approved, but they aren’t inherently unsafe. Compounded medications include critical drugs such as resuscitation medications and antibiotics, and are often used in healthcare settings, especially when there’s a shortage. This raises the question of why compounded GLP-1 agonists would be treated any differently in such scenarios.

And in the case of alternative drugs for individuals with obesity who have a higher risk for cardiovascular disease, the brand-name FDA-approved alternative may be of more concern than the compounded GLP-1 agonist. The obesity societies advise: “If you cannot find or get access to a GLP-1-based treatment now, there are other treatments available,” echoing experts. While the statement doesn’t specify the names of the alternatives, experts have advised using alternatives such as Qsymia and Contrave, despite their potential cardiovascular concerns. This recommendation to the public may not represent a responsible risk-benefit analysis.

Courtesy Dr. Einav

Possible Solutions

When prescribing GLP-1 agonists for obesity treatment, doctors should consider all of the following steps to ensure patient safety and effective treatment:

Preference for FDA-approved brands: FDA-approved branded GLP-1 agonist medications should be the primary choice because of their established safety and efficacy.

Risk-benefit analysis for non–FDA-approved products: In cases where FDA-approved options are not available, doctors may consider prescribing a non–FDA-approved copy of the branded medication. Prior to this, conduct a thorough risk-benefit analysis with the patient, ensuring that they are fully informed about the potential risks and benefits of using a non–FDA-approved product.

Choosing semaglutide copies for specific cases: In patients with obesity and cardiovascular disease, the benefits of using a compounded copy of semaglutide, with its cardiovascular disease–modifying properties, may outweigh the risks compared with other FDA-approved antiobesity drugs that might pose cardiovascular risks or compared with no antiobesity treatment at all.

Informed consent and monitoring: When prescribing a non–FDA-approved version of a GLP-1 agonist, obtaining informed consent from the patient is advised. They should be made aware of the differences between the FDA-approved and nonapproved versions.

Choosing between 503A and 503B pharmacies: Prescriptions for non–FDA-approved GLP-1 agonists can be directed to either 503A or 503B compounding pharmacies. However, it’s advisable to check whether the product can be compounded by a 503B pharmacy, which is subject to an additional layer of FDA regulation, offering greater quality assurance.

Clear prescription specifications: Ensure that the prescription explicitly states that the compounded GLP-1 agonist should be the base compound without additives.

Requesting a Certificate of Analysis: To further ensure safety, request a Certificate of Analysis from the compounding pharmacy. This provides detailed quality and composition information about the product.

Ongoing monitoring: Continuously monitor the patient’s response to the medication and adjust the treatment plan as necessary, maintaining regular follow-ups.

By adhering to these guidelines, doctors can navigate the complexities of prescribing GLP-1 agonists in a way that prioritizes patient well-being, particularly in scenarios where conventional treatment options are limited.
 

Dr. Einav is a board-certified cardiologist and a Diplomate of the American Board of Obesity Medicine. He is a fellow of the American College of Cardiology and a member of the Obesity Medicine Association. He serves as the medical director of cardiometabolic health in Guthrie Lourdes in Binghamton, New York, and is the founder of myW8/Cardiometabolic Health located in Beverly Hills, California. This article solely reflects the personal views of Dr. Einav and should not be considered as representing the official stance of Guthrie Lourdes. Dr. Einav served as a promotional speaker for Novo Nordisk in 2022. As of now, he has not prescribed any compounded GLP-1 agonist medications in his medical practice.

A version of this article appeared on Medscape.com.

As a cardiologist specializing in obesity medicine, I often encounter patients who would greatly benefit from the new generation of weight loss drugs that work as glucagon-like peptide 1 (GLP-1) agonists. In the recently published SELECT trial results, for example, semaglutide (marketed by Novo Nordisk as Wegovy for weight loss and Ozempic for type 2 diabetes) demonstrated a 20% risk reduction of heart attacks and strokes in overweight and obese individuals without diabetes and with cardiovascular disease, establishing it as a cardiovascular disease–modifying medication in people without type 2 diabetes.

Unfortunately, the high demand for these new weight loss medications has resulted in a frustrating, long-lasting shortage. The manufacturers of the two FDA-approved drugs, Novo Nordisk and Eli Lilly (tirzepatide, marketed as Zepbound for weight loss and Mounjaro for type 2 diabetes), are struggling to meet the overwhelming need.

To ensure continuation of patient care, federal law allows compounding pharmacies to make “essentially a copy” of the medications that are listed as “currently in shortage” on the US Food and Drug Administration (FDA) drug shortage list. Both semaglutide and tirzepatide are on that list. For Americans who suffer from obesity and other weight-related diseases, these drugs could be a lifeline.

Despite this, the medical community has broadly criticized the utilization of compounded GLP-1 agonists, even those obtained from reputable and legitimate compounding pharmacies.

Yes, high demand has led to the emergence of unregulated companies and scammers producing substandard or counterfeit versions of these medications.

The FDA has found fraudulent products (masquerading as the weight loss drugs) and has issued warning letters to stop the distribution of illegally marketed semaglutide. “These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients,” it cautions. Some products use a similar-sounding semaglutide sodium salt, which has uncertain safety and efficacy, and had generated warnings from the FDA and state boards of pharmacy.

Many of these products are marketed directly to consumers online through websites and social media, with little to no medical oversight. This practice is a significant concern, as it may affect patient safety, and should be discouraged.

However, according to a statement from the Alliance for Pharmacy Compounding (APC), legitimate compounding pharmacies aren’t the ones selling these dubious products on the black market, particularly online. This illegal practice has garnered media attention and is sometimes incorrectly associated with legitimate pharmacy compounding.

In contrast, legal and certified versions of GLP-1 agonist medications can be obtained from well-regulated and reputable compounding pharmacies. These pharmacies must adhere to all federal and state regulations and dispense medications only with a valid prescription from a licensed physician.

Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products.

There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs.

In the face of this Wild West climate, where compounded drugs may vary in their source, formulation, potency, and purity, The Obesity Society, the Obesity Medical Association, and the Obesity Action Coalition published a joint statement that advised against the use of compounded GLP-1 agonists, citing safety concerns and lack of regulatory oversight.

This stance, while aimed at ensuring patient safety, inadvertently raises a critical issue.

By completely dismissing compounded medications, experts may unintentionally bolster the black market and overlook the needs of patients who could benefit from these medications, contrary to the intentions of the exemption provided in federal law for compounding during a drug shortage. In fact, the presence of unreliable suppliers highlights the need to direct the public toward trustworthy sources, rather than imposing a total ban on medically appropriate alternatives.

The joint statement calls compounded GLP-1 agonists “counterfeit.” This inaccurate overgeneralization probably stems from a misunderstanding of the compounding process and its regulations. Legitimate and regulated pharmacies compound base GLP-1 agonists, which are “essentially a copy” of FDA-approved medications, not counterfeits. Recognizing this is crucial for maintaining trust in both compounding pharmacies and regulatory bodies.

It is correct that “the only FDA-approved manufacturers of these medications are the companies that created the active pharmaceutical ingredients — Novo Nordisk and Eli Lilly,” but the joint statement fails to mention the exemptions provided by law that allow compounding copies of the branded medications if they are on the shortage list.

Compounding pharmacies must obtain active pharmaceutical ingredients (APIs) from FDA-registered facilities, which are required to adhere to Current Good Manufacturing Practices (cGMP). This ensures the APIs’ quality, potency, and purity, crucial for the safety and efficacy of compounded medications.

Compounded drugs are not FDA approved, but they aren’t inherently unsafe. Compounded medications include critical drugs such as resuscitation medications and antibiotics, and are often used in healthcare settings, especially when there’s a shortage. This raises the question of why compounded GLP-1 agonists would be treated any differently in such scenarios.

And in the case of alternative drugs for individuals with obesity who have a higher risk for cardiovascular disease, the brand-name FDA-approved alternative may be of more concern than the compounded GLP-1 agonist. The obesity societies advise: “If you cannot find or get access to a GLP-1-based treatment now, there are other treatments available,” echoing experts. While the statement doesn’t specify the names of the alternatives, experts have advised using alternatives such as Qsymia and Contrave, despite their potential cardiovascular concerns. This recommendation to the public may not represent a responsible risk-benefit analysis.

Courtesy Dr. Einav

Possible Solutions

When prescribing GLP-1 agonists for obesity treatment, doctors should consider all of the following steps to ensure patient safety and effective treatment:

Preference for FDA-approved brands: FDA-approved branded GLP-1 agonist medications should be the primary choice because of their established safety and efficacy.

Risk-benefit analysis for non–FDA-approved products: In cases where FDA-approved options are not available, doctors may consider prescribing a non–FDA-approved copy of the branded medication. Prior to this, conduct a thorough risk-benefit analysis with the patient, ensuring that they are fully informed about the potential risks and benefits of using a non–FDA-approved product.

Choosing semaglutide copies for specific cases: In patients with obesity and cardiovascular disease, the benefits of using a compounded copy of semaglutide, with its cardiovascular disease–modifying properties, may outweigh the risks compared with other FDA-approved antiobesity drugs that might pose cardiovascular risks or compared with no antiobesity treatment at all.

Informed consent and monitoring: When prescribing a non–FDA-approved version of a GLP-1 agonist, obtaining informed consent from the patient is advised. They should be made aware of the differences between the FDA-approved and nonapproved versions.

Choosing between 503A and 503B pharmacies: Prescriptions for non–FDA-approved GLP-1 agonists can be directed to either 503A or 503B compounding pharmacies. However, it’s advisable to check whether the product can be compounded by a 503B pharmacy, which is subject to an additional layer of FDA regulation, offering greater quality assurance.

Clear prescription specifications: Ensure that the prescription explicitly states that the compounded GLP-1 agonist should be the base compound without additives.

Requesting a Certificate of Analysis: To further ensure safety, request a Certificate of Analysis from the compounding pharmacy. This provides detailed quality and composition information about the product.

Ongoing monitoring: Continuously monitor the patient’s response to the medication and adjust the treatment plan as necessary, maintaining regular follow-ups.

By adhering to these guidelines, doctors can navigate the complexities of prescribing GLP-1 agonists in a way that prioritizes patient well-being, particularly in scenarios where conventional treatment options are limited.
 

Dr. Einav is a board-certified cardiologist and a Diplomate of the American Board of Obesity Medicine. He is a fellow of the American College of Cardiology and a member of the Obesity Medicine Association. He serves as the medical director of cardiometabolic health in Guthrie Lourdes in Binghamton, New York, and is the founder of myW8/Cardiometabolic Health located in Beverly Hills, California. This article solely reflects the personal views of Dr. Einav and should not be considered as representing the official stance of Guthrie Lourdes. Dr. Einav served as a promotional speaker for Novo Nordisk in 2022. As of now, he has not prescribed any compounded GLP-1 agonist medications in his medical practice.

A version of this article appeared on Medscape.com.

As a cardiologist specializing in obesity medicine, I often encounter patients who would greatly benefit from the new generation of weight loss drugs that work as glucagon-like peptide 1 (GLP-1) agonists. In the recently published SELECT trial results, for example, semaglutide (marketed by Novo Nordisk as Wegovy for weight loss and Ozempic for type 2 diabetes) demonstrated a 20% risk reduction of heart attacks and strokes in overweight and obese individuals without diabetes and with cardiovascular disease, establishing it as a cardiovascular disease–modifying medication in people without type 2 diabetes.

Unfortunately, the high demand for these new weight loss medications has resulted in a frustrating, long-lasting shortage. The manufacturers of the two FDA-approved drugs, Novo Nordisk and Eli Lilly (tirzepatide, marketed as Zepbound for weight loss and Mounjaro for type 2 diabetes), are struggling to meet the overwhelming need.

To ensure continuation of patient care, federal law allows compounding pharmacies to make “essentially a copy” of the medications that are listed as “currently in shortage” on the US Food and Drug Administration (FDA) drug shortage list. Both semaglutide and tirzepatide are on that list. For Americans who suffer from obesity and other weight-related diseases, these drugs could be a lifeline.

Despite this, the medical community has broadly criticized the utilization of compounded GLP-1 agonists, even those obtained from reputable and legitimate compounding pharmacies.

Yes, high demand has led to the emergence of unregulated companies and scammers producing substandard or counterfeit versions of these medications.

The FDA has found fraudulent products (masquerading as the weight loss drugs) and has issued warning letters to stop the distribution of illegally marketed semaglutide. “These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients,” it cautions. Some products use a similar-sounding semaglutide sodium salt, which has uncertain safety and efficacy, and had generated warnings from the FDA and state boards of pharmacy.

Many of these products are marketed directly to consumers online through websites and social media, with little to no medical oversight. This practice is a significant concern, as it may affect patient safety, and should be discouraged.

However, according to a statement from the Alliance for Pharmacy Compounding (APC), legitimate compounding pharmacies aren’t the ones selling these dubious products on the black market, particularly online. This illegal practice has garnered media attention and is sometimes incorrectly associated with legitimate pharmacy compounding.

In contrast, legal and certified versions of GLP-1 agonist medications can be obtained from well-regulated and reputable compounding pharmacies. These pharmacies must adhere to all federal and state regulations and dispense medications only with a valid prescription from a licensed physician.

Meanwhile, the APC statement notes, Novo Nordisk and Eli Lilly have sued compounding companies in several states, questioning, among other things, the purity and potency of some compounded products.

There are different designations for compounding pharmacies: 503A and 503B. 503As are state-licensed pharmacies and physicians, and 503B pharmacies are federally regulated outsourcing facilities that are strictly regulated by the FDA. This regulation, established following a 2012 fungal meningitis outbreak linked to a compounding pharmacy, ensures higher-quality control and oversight, especially for medications intended for intravenous or epidural use. These standards exceed those required for subcutaneous injections like GLP-1 analogs.

In the face of this Wild West climate, where compounded drugs may vary in their source, formulation, potency, and purity, The Obesity Society, the Obesity Medical Association, and the Obesity Action Coalition published a joint statement that advised against the use of compounded GLP-1 agonists, citing safety concerns and lack of regulatory oversight.

This stance, while aimed at ensuring patient safety, inadvertently raises a critical issue.

By completely dismissing compounded medications, experts may unintentionally bolster the black market and overlook the needs of patients who could benefit from these medications, contrary to the intentions of the exemption provided in federal law for compounding during a drug shortage. In fact, the presence of unreliable suppliers highlights the need to direct the public toward trustworthy sources, rather than imposing a total ban on medically appropriate alternatives.

The joint statement calls compounded GLP-1 agonists “counterfeit.” This inaccurate overgeneralization probably stems from a misunderstanding of the compounding process and its regulations. Legitimate and regulated pharmacies compound base GLP-1 agonists, which are “essentially a copy” of FDA-approved medications, not counterfeits. Recognizing this is crucial for maintaining trust in both compounding pharmacies and regulatory bodies.

It is correct that “the only FDA-approved manufacturers of these medications are the companies that created the active pharmaceutical ingredients — Novo Nordisk and Eli Lilly,” but the joint statement fails to mention the exemptions provided by law that allow compounding copies of the branded medications if they are on the shortage list.

Compounding pharmacies must obtain active pharmaceutical ingredients (APIs) from FDA-registered facilities, which are required to adhere to Current Good Manufacturing Practices (cGMP). This ensures the APIs’ quality, potency, and purity, crucial for the safety and efficacy of compounded medications.

Compounded drugs are not FDA approved, but they aren’t inherently unsafe. Compounded medications include critical drugs such as resuscitation medications and antibiotics, and are often used in healthcare settings, especially when there’s a shortage. This raises the question of why compounded GLP-1 agonists would be treated any differently in such scenarios.

And in the case of alternative drugs for individuals with obesity who have a higher risk for cardiovascular disease, the brand-name FDA-approved alternative may be of more concern than the compounded GLP-1 agonist. The obesity societies advise: “If you cannot find or get access to a GLP-1-based treatment now, there are other treatments available,” echoing experts. While the statement doesn’t specify the names of the alternatives, experts have advised using alternatives such as Qsymia and Contrave, despite their potential cardiovascular concerns. This recommendation to the public may not represent a responsible risk-benefit analysis.

Courtesy Dr. Einav

Possible Solutions

When prescribing GLP-1 agonists for obesity treatment, doctors should consider all of the following steps to ensure patient safety and effective treatment:

Preference for FDA-approved brands: FDA-approved branded GLP-1 agonist medications should be the primary choice because of their established safety and efficacy.

Risk-benefit analysis for non–FDA-approved products: In cases where FDA-approved options are not available, doctors may consider prescribing a non–FDA-approved copy of the branded medication. Prior to this, conduct a thorough risk-benefit analysis with the patient, ensuring that they are fully informed about the potential risks and benefits of using a non–FDA-approved product.

Choosing semaglutide copies for specific cases: In patients with obesity and cardiovascular disease, the benefits of using a compounded copy of semaglutide, with its cardiovascular disease–modifying properties, may outweigh the risks compared with other FDA-approved antiobesity drugs that might pose cardiovascular risks or compared with no antiobesity treatment at all.

Informed consent and monitoring: When prescribing a non–FDA-approved version of a GLP-1 agonist, obtaining informed consent from the patient is advised. They should be made aware of the differences between the FDA-approved and nonapproved versions.

Choosing between 503A and 503B pharmacies: Prescriptions for non–FDA-approved GLP-1 agonists can be directed to either 503A or 503B compounding pharmacies. However, it’s advisable to check whether the product can be compounded by a 503B pharmacy, which is subject to an additional layer of FDA regulation, offering greater quality assurance.

Clear prescription specifications: Ensure that the prescription explicitly states that the compounded GLP-1 agonist should be the base compound without additives.

Requesting a Certificate of Analysis: To further ensure safety, request a Certificate of Analysis from the compounding pharmacy. This provides detailed quality and composition information about the product.

Ongoing monitoring: Continuously monitor the patient’s response to the medication and adjust the treatment plan as necessary, maintaining regular follow-ups.

By adhering to these guidelines, doctors can navigate the complexities of prescribing GLP-1 agonists in a way that prioritizes patient well-being, particularly in scenarios where conventional treatment options are limited.
 

Dr. Einav is a board-certified cardiologist and a Diplomate of the American Board of Obesity Medicine. He is a fellow of the American College of Cardiology and a member of the Obesity Medicine Association. He serves as the medical director of cardiometabolic health in Guthrie Lourdes in Binghamton, New York, and is the founder of myW8/Cardiometabolic Health located in Beverly Hills, California. This article solely reflects the personal views of Dr. Einav and should not be considered as representing the official stance of Guthrie Lourdes. Dr. Einav served as a promotional speaker for Novo Nordisk in 2022. As of now, he has not prescribed any compounded GLP-1 agonist medications in his medical practice.

A version of this article appeared on Medscape.com.

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Higher urinary magnesium loss, as indicated by an elevated magnesium depletion score (MDS), may be an independent risk factor for metabolic syndrome in US adults.

METHODOLOGY:

• Increasing evidence suggests that chronic hypomagnesemia may play a role in the pathogenesis of metabolic disorders, including overweight and obesity, insulin resistance, type 2 diabetes, hypertension, and dyslipidemia.
• Researchers examined the relationship between magnesium status and metabolic syndrome in 15,565 US adults (mean age, 47 years; half women) participating in the National Health and Nutrition Examination Survey (2003-2018), of whom 5438 had metabolic syndrome (mean age, 55 years).
• Magnesium deficiency was predicted by MDS, a four-factor score that aggregates diuretic use (one point), proton pump inhibitor (one point), kidney function (estimated glomerular filtration rate; one or two points), and heavy  (one point).
• MDS was categorized into six levels (by scores 0-5), with a higher MDS indicating a more severe magnesium deficiency.
• Metabolic syndrome was defined according to the National Cholesterol Education Program’s Adult Treatment Panel III report.

TAKEAWAY:

• The proportion of patients with MDS ≥ 2 was higher in the group with vs without metabolic syndrome (P < .05).
• Even after adjusting for potential confounding factors, each 1-unit increase in the MDS increased the odds of metabolic syndrome by about 30% (adjusted odds ratio, 1.31; 95% CI, 1.17-1.45).
• A dose-response relationship was observed between MDS and metabolic syndrome, with MDS level 1 being associated with 1.28-fold higher odds of metabolic syndrome (95% CI, 1.06-1.55) than MDS level 0; further escalation in the odds was noted for MDS levels 2, 3, and 4.
• The association between metabolic syndrome and MDS remained consistent across all population subgroups defined by age, gender, race (except Mexican American), body mass index, drinking status, or smoking status.

IN PRACTICE:

“It is possible to prevent and reduce MetS [metabolic syndrome] by supplementing with magnesium supplements or encouraging higher magnesium intake diet because the diet is a factor that can be changed,” the authors wrote.

SOURCE:

The study was led by Xiaohao Wang, Department of Geriatrics, the First Affiliated Hospital, School of Medicine, Southern University of Science and Technology (Shenzhen People’s Hospital), Shenzhen, China. It was published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study found no significant link between MDS level 5 and metabolic syndrome, likely due to the small sample size at this level. The study could not draw any causal relationship between metabolic syndrome and MDS owing to its cross-sectional nature. It also could not determine whether MDS was a better marker of magnesium deficiency than serum magnesium levels. MDS is a categorical, not continuous, variable.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Shenzhen City, China. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher urinary magnesium loss, as indicated by an elevated magnesium depletion score (MDS), may be an independent risk factor for metabolic syndrome in US adults.

METHODOLOGY:

• Increasing evidence suggests that chronic hypomagnesemia may play a role in the pathogenesis of metabolic disorders, including overweight and obesity, insulin resistance, type 2 diabetes, hypertension, and dyslipidemia.
• Researchers examined the relationship between magnesium status and metabolic syndrome in 15,565 US adults (mean age, 47 years; half women) participating in the National Health and Nutrition Examination Survey (2003-2018), of whom 5438 had metabolic syndrome (mean age, 55 years).
• Magnesium deficiency was predicted by MDS, a four-factor score that aggregates diuretic use (one point), proton pump inhibitor (one point), kidney function (estimated glomerular filtration rate; one or two points), and heavy  (one point).
• MDS was categorized into six levels (by scores 0-5), with a higher MDS indicating a more severe magnesium deficiency.
• Metabolic syndrome was defined according to the National Cholesterol Education Program’s Adult Treatment Panel III report.

TAKEAWAY:

• The proportion of patients with MDS ≥ 2 was higher in the group with vs without metabolic syndrome (P < .05).
• Even after adjusting for potential confounding factors, each 1-unit increase in the MDS increased the odds of metabolic syndrome by about 30% (adjusted odds ratio, 1.31; 95% CI, 1.17-1.45).
• A dose-response relationship was observed between MDS and metabolic syndrome, with MDS level 1 being associated with 1.28-fold higher odds of metabolic syndrome (95% CI, 1.06-1.55) than MDS level 0; further escalation in the odds was noted for MDS levels 2, 3, and 4.
• The association between metabolic syndrome and MDS remained consistent across all population subgroups defined by age, gender, race (except Mexican American), body mass index, drinking status, or smoking status.

IN PRACTICE:

“It is possible to prevent and reduce MetS [metabolic syndrome] by supplementing with magnesium supplements or encouraging higher magnesium intake diet because the diet is a factor that can be changed,” the authors wrote.

SOURCE:

The study was led by Xiaohao Wang, Department of Geriatrics, the First Affiliated Hospital, School of Medicine, Southern University of Science and Technology (Shenzhen People’s Hospital), Shenzhen, China. It was published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study found no significant link between MDS level 5 and metabolic syndrome, likely due to the small sample size at this level. The study could not draw any causal relationship between metabolic syndrome and MDS owing to its cross-sectional nature. It also could not determine whether MDS was a better marker of magnesium deficiency than serum magnesium levels. MDS is a categorical, not continuous, variable.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Shenzhen City, China. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher urinary magnesium loss, as indicated by an elevated magnesium depletion score (MDS), may be an independent risk factor for metabolic syndrome in US adults.

METHODOLOGY:

• Increasing evidence suggests that chronic hypomagnesemia may play a role in the pathogenesis of metabolic disorders, including overweight and obesity, insulin resistance, type 2 diabetes, hypertension, and dyslipidemia.
• Researchers examined the relationship between magnesium status and metabolic syndrome in 15,565 US adults (mean age, 47 years; half women) participating in the National Health and Nutrition Examination Survey (2003-2018), of whom 5438 had metabolic syndrome (mean age, 55 years).
• Magnesium deficiency was predicted by MDS, a four-factor score that aggregates diuretic use (one point), proton pump inhibitor (one point), kidney function (estimated glomerular filtration rate; one or two points), and heavy  (one point).
• MDS was categorized into six levels (by scores 0-5), with a higher MDS indicating a more severe magnesium deficiency.
• Metabolic syndrome was defined according to the National Cholesterol Education Program’s Adult Treatment Panel III report.

TAKEAWAY:

• The proportion of patients with MDS ≥ 2 was higher in the group with vs without metabolic syndrome (P < .05).
• Even after adjusting for potential confounding factors, each 1-unit increase in the MDS increased the odds of metabolic syndrome by about 30% (adjusted odds ratio, 1.31; 95% CI, 1.17-1.45).
• A dose-response relationship was observed between MDS and metabolic syndrome, with MDS level 1 being associated with 1.28-fold higher odds of metabolic syndrome (95% CI, 1.06-1.55) than MDS level 0; further escalation in the odds was noted for MDS levels 2, 3, and 4.
• The association between metabolic syndrome and MDS remained consistent across all population subgroups defined by age, gender, race (except Mexican American), body mass index, drinking status, or smoking status.

IN PRACTICE:

“It is possible to prevent and reduce MetS [metabolic syndrome] by supplementing with magnesium supplements or encouraging higher magnesium intake diet because the diet is a factor that can be changed,” the authors wrote.

SOURCE:

The study was led by Xiaohao Wang, Department of Geriatrics, the First Affiliated Hospital, School of Medicine, Southern University of Science and Technology (Shenzhen People’s Hospital), Shenzhen, China. It was published online in the Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study found no significant link between MDS level 5 and metabolic syndrome, likely due to the small sample size at this level. The study could not draw any causal relationship between metabolic syndrome and MDS owing to its cross-sectional nature. It also could not determine whether MDS was a better marker of magnesium deficiency than serum magnesium levels. MDS is a categorical, not continuous, variable.

DISCLOSURES:

This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Shenzhen City, China. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Amid rising concern about the potential long-term costs of using glucagon-like peptide 1 (GLP-1) agonists to treat obesity, some insurers are making access to bariatric surgery easier.

While the relationship may not be entirely causal, data do suggest that at least for now, these new agents for treating obesity including semaglutide (Wegovy) and tirzepatide (Zepbound) are not cost-effective, whereas the surgery is.

According to GoodRx, Wegovy (semaglutide) has a list price of about $1350 for a 28-day supply. And the American Society for Metabolic and Bariatric Surgery (ASMBS) said that the average cost of bariatric surgery ranges between $17,000 and $26,000. But ASMBS added that third-party payers will recover those costs within 2-4 years due to reduction or elimination of obesity-related conditions and associated treatment costs, with an approximate 29% healthcare cost reduction at 5 years.

Recently, for example, Geisinger Health of Pennsylvania and Blue Cross/Blue Shield of Massachusetts expanded body mass index (BMI) eligibility for bariatric surgery procedures, while Blue Cross Blue Shield of Michigan dropped prior authorization requirements for several services, including bariatric surgery.

While most major health insurers cover Wegovy for obesity treatment, they typically require prior authorization and/or trials of other therapies first. Recently, some employers have denied coverage for the medications for treating obesity. Medicare does not cover these drugs. Coverage varies across state Medicaid plans.

“For years, insurers…have played games with the surgery, making people jump through hoops, hoping that they would just give up and go away. And now that health plans are getting concerned about [the cost of] drugs for obesity, and they’re getting so much attention, they’re thinking oh, maybe we shouldn’t be playing these games anymore,” obesity policy expert Ted Kyle, RPh, founder of ConscienHealth, told this news organization.

However, Christopher Doubet Still, DO, director of Nutrition and Weight Management at Geisinger Medical Center, Danville, Pennsylvania, told this news organization that Geisinger Health Plan’s change in May 2023 to lower the BMI surgery eligibility cutoff from 35 kg/m2 to 30 kg/m2 for people with comorbidities was not related to the cost of GLP-1 drugs.

“To date, bariatric surgery remains the most effective, enduring treatment of obesity, and most importantly, its comorbid medical problems. So that was really the reasoning. The weight loss is secondary to the profound medical benefits of bariatric surgery. I think that was the impetus of that change, not having really anything to do at the time with GLP-1s,” Dr. Still said.

The Geisinger Health Plan does not currently cover antiobesity medications, although Geisinger Health Plan Family, a state Medicaid plan, does because Pennsylvania is now one of a handful of states that cover the medications through Medicaid.
 

The Equation Keeps Changing

Health economist James Chambers, PhD, of Tufts University, Boston, Massachusetts, told this news organizations, “when you think about the value of a treatment, you don’t look at it in isolation. You’re looking at the difference in cost and benefits. So now that you have these expensive drugs, it’s not that surgeries become less expensive, but it does make you interpret the cost differently. When diet and exercise and counseling were the only real options, surgeries seemed like a much more expensive intervention. But with the advent of the GLP-1s, then, maybe plans consider the costs of surgery a little bit differently.”

And that equation is likely to change further, Dr. Still noted.

“I just think we’re dealing with a short-term financial problem because there’s basically only two main medications so the prices are high, but as more medications come on the market, the prices will come down,” he said.

Cristy Ms. Gallagher, MPAff, research project director of the STOP Obesity Alliance at the Milken Institute School of Public Health at George Washington University, Washington, DC, agreed.

“We have a lot of data on obesity treatment coverage from before 2023. But then this [GLP-1] explosion happened in 2023…The health payers are out there trying to figure out coverage, and they’re trying to figure out what this is going to look like for them,” Ms. Gallagher said.

However, she pointed out, “there is no treatment that fits everyone. The GLP-1s won’t work for every person because of the different stages of obesity, the side effects, and then because of the coverage. I think that you will not see a decrease in bariatric surgery in the near term, by any means.”

Ms. Gallagher also noted that although the data now suggest people will have to keep taking the drugs for life, there may be other future approaches.

“Once a person hits their goal weight, maybe then they could be transferred to a different pill form that might be cheaper, something that’s sort of more of a maintenance drug. I think that is a huge unknown right now,” she said.

And Mr. Kyle said that while bariatric surgery does provide the most durable benefit, “weight regain after surgery is a fact of life. People are still healthier 5 years later, but they do have some weight regain. And in those cases, you might want to follow-up with medicines…It’s not necessarily an either/or proposition any more than surgical treatment of cancer, surgical oncology is an either/or with medical oncology.”
 

A New View of Obesity

According to Mr. Kyle, all this attention on the new medications “is prompting people to rethink or think differently about obesity and consider it more carefully as a chronic medical condition and not a condition of appearance and behavior. And that’s all good, whether you’re thinking about it from the standpoint of bariatric surgery or from the standpoint of medical treatment of obesity because then people start considering options more rationally.”

This shifting view of obesity has meant that bariatric surgeons and medical obesity specialists are starting to work more collaboratively, he said.

“There is a trend that I detect toward more integrated approaches to obesity,” Mr. Kyle said.

He added, “We now have more tools. And we’re in the messy middle of figuring out how, as a practical matter, to use them.”

And as far as insurance coverage, “people are going to make mistakes. They are making mistakes. But I have been the eternal optimist, and I have faith that people are also figuring it out. It would be hard to do worse.”

For now, any initiatives to increase bariatric surgery rates in the GLP-1 era haven’t yet had an impact, American Society for Metabolic and Bariatric Surgery President Marina S. Kurian, MD, told this news organization in a statement.

“While we have heard of some insurers possibly changing their requirements for bariatric surgery, we have not seen a significant rise in procedures related to changes in insurance coverage for either antiobesity medications or metabolic and bariatric surgery,” Dr. Kurian said.

Mr. Kyle had accepted speaking or professional fees from Novo Nordisk, Behringer Ingelheim, Nutrisystem, Roman Health, and Emerald Lake Safety. Dr. Still was on the speaker’s bureau and did clinical trials for Eli Lilly and Novo Nordisk. Dr. Chambers and Gallagher had no disclosures.

A version of this article appeared on Medscape.com.

Amid rising concern about the potential long-term costs of using glucagon-like peptide 1 (GLP-1) agonists to treat obesity, some insurers are making access to bariatric surgery easier.

While the relationship may not be entirely causal, data do suggest that at least for now, these new agents for treating obesity including semaglutide (Wegovy) and tirzepatide (Zepbound) are not cost-effective, whereas the surgery is.

According to GoodRx, Wegovy (semaglutide) has a list price of about $1350 for a 28-day supply. And the American Society for Metabolic and Bariatric Surgery (ASMBS) said that the average cost of bariatric surgery ranges between $17,000 and $26,000. But ASMBS added that third-party payers will recover those costs within 2-4 years due to reduction or elimination of obesity-related conditions and associated treatment costs, with an approximate 29% healthcare cost reduction at 5 years.

Recently, for example, Geisinger Health of Pennsylvania and Blue Cross/Blue Shield of Massachusetts expanded body mass index (BMI) eligibility for bariatric surgery procedures, while Blue Cross Blue Shield of Michigan dropped prior authorization requirements for several services, including bariatric surgery.

While most major health insurers cover Wegovy for obesity treatment, they typically require prior authorization and/or trials of other therapies first. Recently, some employers have denied coverage for the medications for treating obesity. Medicare does not cover these drugs. Coverage varies across state Medicaid plans.

“For years, insurers…have played games with the surgery, making people jump through hoops, hoping that they would just give up and go away. And now that health plans are getting concerned about [the cost of] drugs for obesity, and they’re getting so much attention, they’re thinking oh, maybe we shouldn’t be playing these games anymore,” obesity policy expert Ted Kyle, RPh, founder of ConscienHealth, told this news organization.

However, Christopher Doubet Still, DO, director of Nutrition and Weight Management at Geisinger Medical Center, Danville, Pennsylvania, told this news organization that Geisinger Health Plan’s change in May 2023 to lower the BMI surgery eligibility cutoff from 35 kg/m2 to 30 kg/m2 for people with comorbidities was not related to the cost of GLP-1 drugs.

“To date, bariatric surgery remains the most effective, enduring treatment of obesity, and most importantly, its comorbid medical problems. So that was really the reasoning. The weight loss is secondary to the profound medical benefits of bariatric surgery. I think that was the impetus of that change, not having really anything to do at the time with GLP-1s,” Dr. Still said.

The Geisinger Health Plan does not currently cover antiobesity medications, although Geisinger Health Plan Family, a state Medicaid plan, does because Pennsylvania is now one of a handful of states that cover the medications through Medicaid.
 

The Equation Keeps Changing

Health economist James Chambers, PhD, of Tufts University, Boston, Massachusetts, told this news organizations, “when you think about the value of a treatment, you don’t look at it in isolation. You’re looking at the difference in cost and benefits. So now that you have these expensive drugs, it’s not that surgeries become less expensive, but it does make you interpret the cost differently. When diet and exercise and counseling were the only real options, surgeries seemed like a much more expensive intervention. But with the advent of the GLP-1s, then, maybe plans consider the costs of surgery a little bit differently.”

And that equation is likely to change further, Dr. Still noted.

“I just think we’re dealing with a short-term financial problem because there’s basically only two main medications so the prices are high, but as more medications come on the market, the prices will come down,” he said.

Cristy Ms. Gallagher, MPAff, research project director of the STOP Obesity Alliance at the Milken Institute School of Public Health at George Washington University, Washington, DC, agreed.

“We have a lot of data on obesity treatment coverage from before 2023. But then this [GLP-1] explosion happened in 2023…The health payers are out there trying to figure out coverage, and they’re trying to figure out what this is going to look like for them,” Ms. Gallagher said.

However, she pointed out, “there is no treatment that fits everyone. The GLP-1s won’t work for every person because of the different stages of obesity, the side effects, and then because of the coverage. I think that you will not see a decrease in bariatric surgery in the near term, by any means.”

Ms. Gallagher also noted that although the data now suggest people will have to keep taking the drugs for life, there may be other future approaches.

“Once a person hits their goal weight, maybe then they could be transferred to a different pill form that might be cheaper, something that’s sort of more of a maintenance drug. I think that is a huge unknown right now,” she said.

And Mr. Kyle said that while bariatric surgery does provide the most durable benefit, “weight regain after surgery is a fact of life. People are still healthier 5 years later, but they do have some weight regain. And in those cases, you might want to follow-up with medicines…It’s not necessarily an either/or proposition any more than surgical treatment of cancer, surgical oncology is an either/or with medical oncology.”
 

A New View of Obesity

According to Mr. Kyle, all this attention on the new medications “is prompting people to rethink or think differently about obesity and consider it more carefully as a chronic medical condition and not a condition of appearance and behavior. And that’s all good, whether you’re thinking about it from the standpoint of bariatric surgery or from the standpoint of medical treatment of obesity because then people start considering options more rationally.”

This shifting view of obesity has meant that bariatric surgeons and medical obesity specialists are starting to work more collaboratively, he said.

“There is a trend that I detect toward more integrated approaches to obesity,” Mr. Kyle said.

He added, “We now have more tools. And we’re in the messy middle of figuring out how, as a practical matter, to use them.”

And as far as insurance coverage, “people are going to make mistakes. They are making mistakes. But I have been the eternal optimist, and I have faith that people are also figuring it out. It would be hard to do worse.”

For now, any initiatives to increase bariatric surgery rates in the GLP-1 era haven’t yet had an impact, American Society for Metabolic and Bariatric Surgery President Marina S. Kurian, MD, told this news organization in a statement.

“While we have heard of some insurers possibly changing their requirements for bariatric surgery, we have not seen a significant rise in procedures related to changes in insurance coverage for either antiobesity medications or metabolic and bariatric surgery,” Dr. Kurian said.

Mr. Kyle had accepted speaking or professional fees from Novo Nordisk, Behringer Ingelheim, Nutrisystem, Roman Health, and Emerald Lake Safety. Dr. Still was on the speaker’s bureau and did clinical trials for Eli Lilly and Novo Nordisk. Dr. Chambers and Gallagher had no disclosures.

A version of this article appeared on Medscape.com.

Amid rising concern about the potential long-term costs of using glucagon-like peptide 1 (GLP-1) agonists to treat obesity, some insurers are making access to bariatric surgery easier.

While the relationship may not be entirely causal, data do suggest that at least for now, these new agents for treating obesity including semaglutide (Wegovy) and tirzepatide (Zepbound) are not cost-effective, whereas the surgery is.

According to GoodRx, Wegovy (semaglutide) has a list price of about $1350 for a 28-day supply. And the American Society for Metabolic and Bariatric Surgery (ASMBS) said that the average cost of bariatric surgery ranges between $17,000 and $26,000. But ASMBS added that third-party payers will recover those costs within 2-4 years due to reduction or elimination of obesity-related conditions and associated treatment costs, with an approximate 29% healthcare cost reduction at 5 years.

Recently, for example, Geisinger Health of Pennsylvania and Blue Cross/Blue Shield of Massachusetts expanded body mass index (BMI) eligibility for bariatric surgery procedures, while Blue Cross Blue Shield of Michigan dropped prior authorization requirements for several services, including bariatric surgery.

While most major health insurers cover Wegovy for obesity treatment, they typically require prior authorization and/or trials of other therapies first. Recently, some employers have denied coverage for the medications for treating obesity. Medicare does not cover these drugs. Coverage varies across state Medicaid plans.

“For years, insurers…have played games with the surgery, making people jump through hoops, hoping that they would just give up and go away. And now that health plans are getting concerned about [the cost of] drugs for obesity, and they’re getting so much attention, they’re thinking oh, maybe we shouldn’t be playing these games anymore,” obesity policy expert Ted Kyle, RPh, founder of ConscienHealth, told this news organization.

However, Christopher Doubet Still, DO, director of Nutrition and Weight Management at Geisinger Medical Center, Danville, Pennsylvania, told this news organization that Geisinger Health Plan’s change in May 2023 to lower the BMI surgery eligibility cutoff from 35 kg/m2 to 30 kg/m2 for people with comorbidities was not related to the cost of GLP-1 drugs.

“To date, bariatric surgery remains the most effective, enduring treatment of obesity, and most importantly, its comorbid medical problems. So that was really the reasoning. The weight loss is secondary to the profound medical benefits of bariatric surgery. I think that was the impetus of that change, not having really anything to do at the time with GLP-1s,” Dr. Still said.

The Geisinger Health Plan does not currently cover antiobesity medications, although Geisinger Health Plan Family, a state Medicaid plan, does because Pennsylvania is now one of a handful of states that cover the medications through Medicaid.
 

The Equation Keeps Changing

Health economist James Chambers, PhD, of Tufts University, Boston, Massachusetts, told this news organizations, “when you think about the value of a treatment, you don’t look at it in isolation. You’re looking at the difference in cost and benefits. So now that you have these expensive drugs, it’s not that surgeries become less expensive, but it does make you interpret the cost differently. When diet and exercise and counseling were the only real options, surgeries seemed like a much more expensive intervention. But with the advent of the GLP-1s, then, maybe plans consider the costs of surgery a little bit differently.”

And that equation is likely to change further, Dr. Still noted.

“I just think we’re dealing with a short-term financial problem because there’s basically only two main medications so the prices are high, but as more medications come on the market, the prices will come down,” he said.

Cristy Ms. Gallagher, MPAff, research project director of the STOP Obesity Alliance at the Milken Institute School of Public Health at George Washington University, Washington, DC, agreed.

“We have a lot of data on obesity treatment coverage from before 2023. But then this [GLP-1] explosion happened in 2023…The health payers are out there trying to figure out coverage, and they’re trying to figure out what this is going to look like for them,” Ms. Gallagher said.

However, she pointed out, “there is no treatment that fits everyone. The GLP-1s won’t work for every person because of the different stages of obesity, the side effects, and then because of the coverage. I think that you will not see a decrease in bariatric surgery in the near term, by any means.”

Ms. Gallagher also noted that although the data now suggest people will have to keep taking the drugs for life, there may be other future approaches.

“Once a person hits their goal weight, maybe then they could be transferred to a different pill form that might be cheaper, something that’s sort of more of a maintenance drug. I think that is a huge unknown right now,” she said.

And Mr. Kyle said that while bariatric surgery does provide the most durable benefit, “weight regain after surgery is a fact of life. People are still healthier 5 years later, but they do have some weight regain. And in those cases, you might want to follow-up with medicines…It’s not necessarily an either/or proposition any more than surgical treatment of cancer, surgical oncology is an either/or with medical oncology.”
 

A New View of Obesity

According to Mr. Kyle, all this attention on the new medications “is prompting people to rethink or think differently about obesity and consider it more carefully as a chronic medical condition and not a condition of appearance and behavior. And that’s all good, whether you’re thinking about it from the standpoint of bariatric surgery or from the standpoint of medical treatment of obesity because then people start considering options more rationally.”

This shifting view of obesity has meant that bariatric surgeons and medical obesity specialists are starting to work more collaboratively, he said.

“There is a trend that I detect toward more integrated approaches to obesity,” Mr. Kyle said.

He added, “We now have more tools. And we’re in the messy middle of figuring out how, as a practical matter, to use them.”

And as far as insurance coverage, “people are going to make mistakes. They are making mistakes. But I have been the eternal optimist, and I have faith that people are also figuring it out. It would be hard to do worse.”

For now, any initiatives to increase bariatric surgery rates in the GLP-1 era haven’t yet had an impact, American Society for Metabolic and Bariatric Surgery President Marina S. Kurian, MD, told this news organization in a statement.

“While we have heard of some insurers possibly changing their requirements for bariatric surgery, we have not seen a significant rise in procedures related to changes in insurance coverage for either antiobesity medications or metabolic and bariatric surgery,” Dr. Kurian said.

Mr. Kyle had accepted speaking or professional fees from Novo Nordisk, Behringer Ingelheim, Nutrisystem, Roman Health, and Emerald Lake Safety. Dr. Still was on the speaker’s bureau and did clinical trials for Eli Lilly and Novo Nordisk. Dr. Chambers and Gallagher had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Anti-osteoporosis medications reduce fracture risk similarly, regardless of whether patients are younger or older than 70 years.

METHODOLOGY:

• Investigators conducted the study as part of a  to assess bone mineral density as a surrogate marker for fracture risk.
• Analyses used individual patient data from 23 randomized placebo-controlled trials of anti-osteoporosis medications (11 of bisphosphonates, four of selective estrogen receptor modulators, three of anabolic medications, two of hormone replacement therapy, and one each of odanacatib, denosumab, and romosozumab).
• Overall, 43% of the included 123,164 patients were aged 70 years or older.
• The main outcomes were fractures and bone mineral density.

TAKEAWAY:

• There was a similar benefit regardless of age when it came to the reduction in risks for hip fracture (odds ratio, 0.65 vs 0.72; P for interaction = .50) and any fracture (odds ratio, 0.72 vs 0.70; P for interaction = .20).
• Findings were comparable in analyses restricted to bisphosphonate trials, except that the reduction in hip fracture risk was greater among the younger group (hazard ratio, 0.44 vs 0.79; P for interaction = .02).
• The benefit of anti-osteoporosis medication in increasing hip and spine bone mineral density at 24 months was significantly greater among the older patients.

IN PRACTICE:

Taken together, the study results “strongly support treatment in those over age 70,” the authors wrote. “These are important findings with potential impact in patient treatment since it goes against a common misconception that medications are less effective in older people,” they added.

SOURCE:

The study was led by Marian Schini, MD, PhD, FHEA, University of Sheffield, England, and was published online in the Journal of Bone and Mineral Research.

LIMITATIONS:

Limitations included a preponderance of female patients (99%), possible residual confounding, a lack of analysis of adverse effects, and potentially different findings using alternate age cutoffs.

DISCLOSURES:

The study was funded by the American Society for Bone Mineral Research. Some authors disclosed affiliations with companies that manufacture anti-osteoporosis drugs.

A version of this article appeared on Medscape.com.

TOPLINE:

Anti-osteoporosis medications reduce fracture risk similarly, regardless of whether patients are younger or older than 70 years.

METHODOLOGY:

• Investigators conducted the study as part of a  to assess bone mineral density as a surrogate marker for fracture risk.
• Analyses used individual patient data from 23 randomized placebo-controlled trials of anti-osteoporosis medications (11 of bisphosphonates, four of selective estrogen receptor modulators, three of anabolic medications, two of hormone replacement therapy, and one each of odanacatib, denosumab, and romosozumab).
• Overall, 43% of the included 123,164 patients were aged 70 years or older.
• The main outcomes were fractures and bone mineral density.

TAKEAWAY:

• There was a similar benefit regardless of age when it came to the reduction in risks for hip fracture (odds ratio, 0.65 vs 0.72; P for interaction = .50) and any fracture (odds ratio, 0.72 vs 0.70; P for interaction = .20).
• Findings were comparable in analyses restricted to bisphosphonate trials, except that the reduction in hip fracture risk was greater among the younger group (hazard ratio, 0.44 vs 0.79; P for interaction = .02).
• The benefit of anti-osteoporosis medication in increasing hip and spine bone mineral density at 24 months was significantly greater among the older patients.

IN PRACTICE:

Taken together, the study results “strongly support treatment in those over age 70,” the authors wrote. “These are important findings with potential impact in patient treatment since it goes against a common misconception that medications are less effective in older people,” they added.

SOURCE:

The study was led by Marian Schini, MD, PhD, FHEA, University of Sheffield, England, and was published online in the Journal of Bone and Mineral Research.

LIMITATIONS:

Limitations included a preponderance of female patients (99%), possible residual confounding, a lack of analysis of adverse effects, and potentially different findings using alternate age cutoffs.

DISCLOSURES:

The study was funded by the American Society for Bone Mineral Research. Some authors disclosed affiliations with companies that manufacture anti-osteoporosis drugs.

A version of this article appeared on Medscape.com.

TOPLINE:

Anti-osteoporosis medications reduce fracture risk similarly, regardless of whether patients are younger or older than 70 years.

METHODOLOGY:

• Investigators conducted the study as part of a  to assess bone mineral density as a surrogate marker for fracture risk.
• Analyses used individual patient data from 23 randomized placebo-controlled trials of anti-osteoporosis medications (11 of bisphosphonates, four of selective estrogen receptor modulators, three of anabolic medications, two of hormone replacement therapy, and one each of odanacatib, denosumab, and romosozumab).
• Overall, 43% of the included 123,164 patients were aged 70 years or older.
• The main outcomes were fractures and bone mineral density.

TAKEAWAY:

• There was a similar benefit regardless of age when it came to the reduction in risks for hip fracture (odds ratio, 0.65 vs 0.72; P for interaction = .50) and any fracture (odds ratio, 0.72 vs 0.70; P for interaction = .20).
• Findings were comparable in analyses restricted to bisphosphonate trials, except that the reduction in hip fracture risk was greater among the younger group (hazard ratio, 0.44 vs 0.79; P for interaction = .02).
• The benefit of anti-osteoporosis medication in increasing hip and spine bone mineral density at 24 months was significantly greater among the older patients.

IN PRACTICE:

Taken together, the study results “strongly support treatment in those over age 70,” the authors wrote. “These are important findings with potential impact in patient treatment since it goes against a common misconception that medications are less effective in older people,” they added.

SOURCE:

The study was led by Marian Schini, MD, PhD, FHEA, University of Sheffield, England, and was published online in the Journal of Bone and Mineral Research.

LIMITATIONS:

Limitations included a preponderance of female patients (99%), possible residual confounding, a lack of analysis of adverse effects, and potentially different findings using alternate age cutoffs.

DISCLOSURES:

The study was funded by the American Society for Bone Mineral Research. Some authors disclosed affiliations with companies that manufacture anti-osteoporosis drugs.

A version of this article appeared on Medscape.com.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are often not prescribed or accessible to people who could benefit from them, a trio of new studies suggested.

First approved for the treatment of type 2 diabetes, the indications for SGLT2 inhibitors and GLP-1 RA medications have now been extended to people with obesity, heart failure, and chronic kidney disease.

The papers were presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

The new data show there is “work to be done in terms of access and equity to these treatments,” Robert H. Eckel, MD, who was not involved in the research, said in a conference statement.

“There is no question that the cost of these medications is high, yet when issues go beyond coverage and include sociodemographic and racial differences that influence treatment, these major issues need to be evaluated and addressed,” said Dr. Eckel, professor emeritus of medicine, Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Denver, and a past president of the AHA.
 

Low Prescription Rates

In one study, researchers analyzed health records for 18,164 adults with obesity (mean age, 51 years; 64% women; mean body mass index [BMI], 36 kg/m2) who had health insurance covering semaglutide and liraglutide (GLP-1 RAs) and tirzepatide (GLP-1/glucose-dependent insulinotropic polypeptide RA). The cohort was 54% White, 35% Black, and 5% Asian.

Only about 3% of eligible adults were prescribed one of these medications, reported Meron Haile, BS, a second-year medical student at Johns Hopkins University School of Medicine in Baltimore, and colleagues.

The likelihood of prescription was lower among Black patients (odds ratio [OR], 0.76) and men (OR, 0.54) and higher in people with higher BMI (OR, 1.06 per 1-unit higher BMI).

Living in a neighborhood with a higher area deprivation index or lower income was not independently associated with the likelihood of prescription.

Individuals with diabetes or hypertension were more likely to be prescribed one of these medications (OR, 3.52 and 1.36, respectively).

“While prescription rates for new obesity therapies are low among the overall population, we saw pronounced lower accessibility among Black adults, who exhibit a higher burden of severe obesity, hypertension, and type 2 diabetes,” Haile said in a conference statement.

“There is a crucial need for understanding prescription practices for obesity medications and to facilitate similar access among people in all races and ethnic groups,” Haile added.

Similar findings emerged in a separate study, in which researchers analyzed the health records of 687,165 adults with type 2 diabetes treated at six large health systems from 2014 to 2022.

The rate of annual pharmacy dispensing of SGLT2 inhibitors and GLP-1 RA medications rose during the study period, but there were clear racial and ethnic differences in prescribing.

In fully adjusted models, SGLT2 inhibitors dispensing was lower for American Indian/Alaska Native (AI/AN; OR, 0.80), Black (OR, 0.89), and Hispanic (OR, 0.87) individuals than for White patients.

Likewise, GLP-1 RA dispensing was also lower for AI/AN (OR, 0.78), Asian (OR, 0.50), Black (OR, 0.86), Hawaiian/Pacific Islander (OR, 0.52), and Hispanic (OR, 0.69) patients than for White patients.

“It’s possible that not all patients have equal access to information about these medications or that not all patients are equally comfortable asking their doctors about them,” lead author Luis A. Rodriguez, PhD, research scientist at Kaiser Permanente’s Northern California Division of Research, Oakland, told this news organization.

“We also don’t know if the cost of the new medications contributed to what we found or if some patients prefer to keep taking a pill rather than switch to some of the GLP-1 receptor agonists that are self-injectable medications. We need to learn more about why this is happening,” Dr. Rodriguez said.
 

‘Concerning’ Data Raise Key Questions

The third study explored how often prescribing recommendations for SGLT2 inhibitors are followed.

“Our study revealed a significant gap between the recommendations for prescribing SGLT2 inhibitors and the actual prescription rates among patients who could benefit from them,” Jung-Im Shin, MD, PhD, with the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, told this news organization.

“This could have important implications for patient care and outcomes, as SGLT2 inhibitors have been shown to be effective for heart and kidney protection in people with high-risk type 2 diabetes, chronic kidney disease, or heart failure,” Dr. Shin said.

Dr. Shin and colleagues analyzed the health records for more than 700,000 adults with type 2 diabetes and 2.5 million people without type 2 diabetes, who received care in 28 US health systems from 2022 to 2023.

Among people with type 2 diabetes recommended for first-line SGLT2 inhibitors treatment, only 12% received a prescription for a SGLT2 inhibitor, and there was no significant difference in prescription between people who met the criteria for first-line SGLT2 inhibitors treatment vs people who did not meet the criteria.

Among people without type 2 diabetes, SGLT2 inhibitor prescription was substantially lower, with only about 3% of people with conditions that are guideline-recommended for SGLT2 inhibitors receiving a prescription.

SGLT2 inhibitor prescription rates varied across health systems; however, less than 30% of people who met guideline criteria received a SGLT2 inhibitors prescription across all health systems in the study.

“Barriers to SGLT2 inhibitor prescription include limited insurance coverage, prohibitive out-of-pocket costs, formulary restrictions, and lack of physicians’ awareness or familiarity regarding benefits and appropriate indications for SGLT2 inhibitors,” Dr. Shin said.

“Efforts to improve access and affordability of SGLT2 inhibitors along with strategies to educate both patients and providers on the updated guidelines for SGLT2 inhibitors use may increase adoption,” Dr. Shin added.

In a conference recording, Dr. Eckel said he found it “particularly concerning” that among patients with insurance to help pay for these medications, “there were still discrepancies” between prescriptions to Asian and Black vs White patients, “who are being prescribed these important medications.”

“Why these medications are not being offered more regularly by healthcare providers” needs to be addressed, Dr. Eckel said. “I think part of it is ignorance and inadequate education as to their new indications for treatment of diseases that go beyond type 2 diabetes,” he noted.

None of the studies had commercial funding. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are often not prescribed or accessible to people who could benefit from them, a trio of new studies suggested.

First approved for the treatment of type 2 diabetes, the indications for SGLT2 inhibitors and GLP-1 RA medications have now been extended to people with obesity, heart failure, and chronic kidney disease.

The papers were presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

The new data show there is “work to be done in terms of access and equity to these treatments,” Robert H. Eckel, MD, who was not involved in the research, said in a conference statement.

“There is no question that the cost of these medications is high, yet when issues go beyond coverage and include sociodemographic and racial differences that influence treatment, these major issues need to be evaluated and addressed,” said Dr. Eckel, professor emeritus of medicine, Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Denver, and a past president of the AHA.
 

Low Prescription Rates

In one study, researchers analyzed health records for 18,164 adults with obesity (mean age, 51 years; 64% women; mean body mass index [BMI], 36 kg/m2) who had health insurance covering semaglutide and liraglutide (GLP-1 RAs) and tirzepatide (GLP-1/glucose-dependent insulinotropic polypeptide RA). The cohort was 54% White, 35% Black, and 5% Asian.

Only about 3% of eligible adults were prescribed one of these medications, reported Meron Haile, BS, a second-year medical student at Johns Hopkins University School of Medicine in Baltimore, and colleagues.

The likelihood of prescription was lower among Black patients (odds ratio [OR], 0.76) and men (OR, 0.54) and higher in people with higher BMI (OR, 1.06 per 1-unit higher BMI).

Living in a neighborhood with a higher area deprivation index or lower income was not independently associated with the likelihood of prescription.

Individuals with diabetes or hypertension were more likely to be prescribed one of these medications (OR, 3.52 and 1.36, respectively).

“While prescription rates for new obesity therapies are low among the overall population, we saw pronounced lower accessibility among Black adults, who exhibit a higher burden of severe obesity, hypertension, and type 2 diabetes,” Haile said in a conference statement.

“There is a crucial need for understanding prescription practices for obesity medications and to facilitate similar access among people in all races and ethnic groups,” Haile added.

Similar findings emerged in a separate study, in which researchers analyzed the health records of 687,165 adults with type 2 diabetes treated at six large health systems from 2014 to 2022.

The rate of annual pharmacy dispensing of SGLT2 inhibitors and GLP-1 RA medications rose during the study period, but there were clear racial and ethnic differences in prescribing.

In fully adjusted models, SGLT2 inhibitors dispensing was lower for American Indian/Alaska Native (AI/AN; OR, 0.80), Black (OR, 0.89), and Hispanic (OR, 0.87) individuals than for White patients.

Likewise, GLP-1 RA dispensing was also lower for AI/AN (OR, 0.78), Asian (OR, 0.50), Black (OR, 0.86), Hawaiian/Pacific Islander (OR, 0.52), and Hispanic (OR, 0.69) patients than for White patients.

“It’s possible that not all patients have equal access to information about these medications or that not all patients are equally comfortable asking their doctors about them,” lead author Luis A. Rodriguez, PhD, research scientist at Kaiser Permanente’s Northern California Division of Research, Oakland, told this news organization.

“We also don’t know if the cost of the new medications contributed to what we found or if some patients prefer to keep taking a pill rather than switch to some of the GLP-1 receptor agonists that are self-injectable medications. We need to learn more about why this is happening,” Dr. Rodriguez said.
 

‘Concerning’ Data Raise Key Questions

The third study explored how often prescribing recommendations for SGLT2 inhibitors are followed.

“Our study revealed a significant gap between the recommendations for prescribing SGLT2 inhibitors and the actual prescription rates among patients who could benefit from them,” Jung-Im Shin, MD, PhD, with the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, told this news organization.

“This could have important implications for patient care and outcomes, as SGLT2 inhibitors have been shown to be effective for heart and kidney protection in people with high-risk type 2 diabetes, chronic kidney disease, or heart failure,” Dr. Shin said.

Dr. Shin and colleagues analyzed the health records for more than 700,000 adults with type 2 diabetes and 2.5 million people without type 2 diabetes, who received care in 28 US health systems from 2022 to 2023.

Among people with type 2 diabetes recommended for first-line SGLT2 inhibitors treatment, only 12% received a prescription for a SGLT2 inhibitor, and there was no significant difference in prescription between people who met the criteria for first-line SGLT2 inhibitors treatment vs people who did not meet the criteria.

Among people without type 2 diabetes, SGLT2 inhibitor prescription was substantially lower, with only about 3% of people with conditions that are guideline-recommended for SGLT2 inhibitors receiving a prescription.

SGLT2 inhibitor prescription rates varied across health systems; however, less than 30% of people who met guideline criteria received a SGLT2 inhibitors prescription across all health systems in the study.

“Barriers to SGLT2 inhibitor prescription include limited insurance coverage, prohibitive out-of-pocket costs, formulary restrictions, and lack of physicians’ awareness or familiarity regarding benefits and appropriate indications for SGLT2 inhibitors,” Dr. Shin said.

“Efforts to improve access and affordability of SGLT2 inhibitors along with strategies to educate both patients and providers on the updated guidelines for SGLT2 inhibitors use may increase adoption,” Dr. Shin added.

In a conference recording, Dr. Eckel said he found it “particularly concerning” that among patients with insurance to help pay for these medications, “there were still discrepancies” between prescriptions to Asian and Black vs White patients, “who are being prescribed these important medications.”

“Why these medications are not being offered more regularly by healthcare providers” needs to be addressed, Dr. Eckel said. “I think part of it is ignorance and inadequate education as to their new indications for treatment of diseases that go beyond type 2 diabetes,” he noted.

None of the studies had commercial funding. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are often not prescribed or accessible to people who could benefit from them, a trio of new studies suggested.

First approved for the treatment of type 2 diabetes, the indications for SGLT2 inhibitors and GLP-1 RA medications have now been extended to people with obesity, heart failure, and chronic kidney disease.

The papers were presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

The new data show there is “work to be done in terms of access and equity to these treatments,” Robert H. Eckel, MD, who was not involved in the research, said in a conference statement.

“There is no question that the cost of these medications is high, yet when issues go beyond coverage and include sociodemographic and racial differences that influence treatment, these major issues need to be evaluated and addressed,” said Dr. Eckel, professor emeritus of medicine, Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Denver, and a past president of the AHA.
 

Low Prescription Rates

In one study, researchers analyzed health records for 18,164 adults with obesity (mean age, 51 years; 64% women; mean body mass index [BMI], 36 kg/m2) who had health insurance covering semaglutide and liraglutide (GLP-1 RAs) and tirzepatide (GLP-1/glucose-dependent insulinotropic polypeptide RA). The cohort was 54% White, 35% Black, and 5% Asian.

Only about 3% of eligible adults were prescribed one of these medications, reported Meron Haile, BS, a second-year medical student at Johns Hopkins University School of Medicine in Baltimore, and colleagues.

The likelihood of prescription was lower among Black patients (odds ratio [OR], 0.76) and men (OR, 0.54) and higher in people with higher BMI (OR, 1.06 per 1-unit higher BMI).

Living in a neighborhood with a higher area deprivation index or lower income was not independently associated with the likelihood of prescription.

Individuals with diabetes or hypertension were more likely to be prescribed one of these medications (OR, 3.52 and 1.36, respectively).

“While prescription rates for new obesity therapies are low among the overall population, we saw pronounced lower accessibility among Black adults, who exhibit a higher burden of severe obesity, hypertension, and type 2 diabetes,” Haile said in a conference statement.

“There is a crucial need for understanding prescription practices for obesity medications and to facilitate similar access among people in all races and ethnic groups,” Haile added.

Similar findings emerged in a separate study, in which researchers analyzed the health records of 687,165 adults with type 2 diabetes treated at six large health systems from 2014 to 2022.

The rate of annual pharmacy dispensing of SGLT2 inhibitors and GLP-1 RA medications rose during the study period, but there were clear racial and ethnic differences in prescribing.

In fully adjusted models, SGLT2 inhibitors dispensing was lower for American Indian/Alaska Native (AI/AN; OR, 0.80), Black (OR, 0.89), and Hispanic (OR, 0.87) individuals than for White patients.

Likewise, GLP-1 RA dispensing was also lower for AI/AN (OR, 0.78), Asian (OR, 0.50), Black (OR, 0.86), Hawaiian/Pacific Islander (OR, 0.52), and Hispanic (OR, 0.69) patients than for White patients.

“It’s possible that not all patients have equal access to information about these medications or that not all patients are equally comfortable asking their doctors about them,” lead author Luis A. Rodriguez, PhD, research scientist at Kaiser Permanente’s Northern California Division of Research, Oakland, told this news organization.

“We also don’t know if the cost of the new medications contributed to what we found or if some patients prefer to keep taking a pill rather than switch to some of the GLP-1 receptor agonists that are self-injectable medications. We need to learn more about why this is happening,” Dr. Rodriguez said.
 

‘Concerning’ Data Raise Key Questions

The third study explored how often prescribing recommendations for SGLT2 inhibitors are followed.

“Our study revealed a significant gap between the recommendations for prescribing SGLT2 inhibitors and the actual prescription rates among patients who could benefit from them,” Jung-Im Shin, MD, PhD, with the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, told this news organization.

“This could have important implications for patient care and outcomes, as SGLT2 inhibitors have been shown to be effective for heart and kidney protection in people with high-risk type 2 diabetes, chronic kidney disease, or heart failure,” Dr. Shin said.

Dr. Shin and colleagues analyzed the health records for more than 700,000 adults with type 2 diabetes and 2.5 million people without type 2 diabetes, who received care in 28 US health systems from 2022 to 2023.

Among people with type 2 diabetes recommended for first-line SGLT2 inhibitors treatment, only 12% received a prescription for a SGLT2 inhibitor, and there was no significant difference in prescription between people who met the criteria for first-line SGLT2 inhibitors treatment vs people who did not meet the criteria.

Among people without type 2 diabetes, SGLT2 inhibitor prescription was substantially lower, with only about 3% of people with conditions that are guideline-recommended for SGLT2 inhibitors receiving a prescription.

SGLT2 inhibitor prescription rates varied across health systems; however, less than 30% of people who met guideline criteria received a SGLT2 inhibitors prescription across all health systems in the study.

“Barriers to SGLT2 inhibitor prescription include limited insurance coverage, prohibitive out-of-pocket costs, formulary restrictions, and lack of physicians’ awareness or familiarity regarding benefits and appropriate indications for SGLT2 inhibitors,” Dr. Shin said.

“Efforts to improve access and affordability of SGLT2 inhibitors along with strategies to educate both patients and providers on the updated guidelines for SGLT2 inhibitors use may increase adoption,” Dr. Shin added.

In a conference recording, Dr. Eckel said he found it “particularly concerning” that among patients with insurance to help pay for these medications, “there were still discrepancies” between prescriptions to Asian and Black vs White patients, “who are being prescribed these important medications.”

“Why these medications are not being offered more regularly by healthcare providers” needs to be addressed, Dr. Eckel said. “I think part of it is ignorance and inadequate education as to their new indications for treatment of diseases that go beyond type 2 diabetes,” he noted.

None of the studies had commercial funding. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

The addition of supervised exercise to obesity pharmacotherapy has shown greater potential for maintaining weight loss and improving body composition after treatment termination than pharmacotherapy alone.

METHODOLOGY:

• Despite significant weight loss achieved with incretin-based obesity pharmacotherapies, their high costs and gastrointestinal adverse events lead to high discontinuation rates with subsequent regaining of weight and body fat.
• Researchers investigated if a strategy involving both exercise and , a -like peptide-1 receptor agonist, was better than either intervention alone in terms of maintaining weight loss and body composition after treatment termination.
• They conducted a 1-year posttreatment analysis of the S-LiTE study, including 109 adults with obesity (age, 18-65 years; body mass index, 32-43) who completed an 8-week low-calorie diet resulting in ≥ 5% weight loss.
• Participants were then randomly allocated to a 52-week weight loss maintenance intervention with either liraglutide or placebo alone or liraglutide or placebo plus supervised exercise.
• The primary outcome was the change in body weight (kg) from randomization to 1 year after the termination of weight maintenance intervention (0-104 weeks), and the secondary outcome was the change in body-fat percentage from 0 to 104 weeks.

TAKEAWAY:

• From week 0 to week 104, supervised exercise plus liraglutide led to 5.1 kg lower weight gain (P = .040) and a 2.3%-point greater decrease in body-fat percentage (P = .026) than liraglutide alone.
• During the 1 year after treatment termination (52-104 weeks), those in the liraglutide group regained 6 kg (95% CI, 2.1-10.0) more than those who were in the supervised exercise plus placebo group, and 2.5 kg (95% CI, -1.5 to 6.5) more than those who received supervised exercise plus liraglutide.
• After 1 year of treatment termination (week 104), the supervised exercise plus liraglutide group had significantly higher odds of maintaining a weight loss of ≥ 10% of initial body weight than the liraglutide (odds ratio [OR], 4.2; 95% CI, 1.6-10.8) or placebo (OR, 7.2; 95% CI, 2.4-21.3) groups.
• The combination of exercise and liraglutide also improved physical functioning along with energy and fatigue scores.

IN PRACTICE:

“Future lifestyle-based treatments during obesity pharmacotherapy may further improve body weight and composition outcomes, with an additional focus on strategies and tools to maintain healthy physical activity habits after termination of pharmacotherapy,” the researchers wrote.

SOURCE:

This study, with lead author Simon Birk Kjær Jensen, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark, was published online in eClinicalMedicine.

LIMITATIONS:

Fewer participants from the placebo group took part in this posttreatment study. Across all treatment groups, participants who attended the posttreatment study had a better mean treatment response during the active treatment than those who did not attend.

DISCLOSURES:

The study was funded by the Novo Nordisk Foundation and Helsefonden. Some authors declared participating in advisory boards and receiving research grants and lecture fees from various sources including Novo Nordisk.

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

TOPLINE:

The addition of supervised exercise to obesity pharmacotherapy has shown greater potential for maintaining weight loss and improving body composition after treatment termination than pharmacotherapy alone.

METHODOLOGY:

• Despite significant weight loss achieved with incretin-based obesity pharmacotherapies, their high costs and gastrointestinal adverse events lead to high discontinuation rates with subsequent regaining of weight and body fat.
• Researchers investigated if a strategy involving both exercise and , a -like peptide-1 receptor agonist, was better than either intervention alone in terms of maintaining weight loss and body composition after treatment termination.
• They conducted a 1-year posttreatment analysis of the S-LiTE study, including 109 adults with obesity (age, 18-65 years; body mass index, 32-43) who completed an 8-week low-calorie diet resulting in ≥ 5% weight loss.
• Participants were then randomly allocated to a 52-week weight loss maintenance intervention with either liraglutide or placebo alone or liraglutide or placebo plus supervised exercise.
• The primary outcome was the change in body weight (kg) from randomization to 1 year after the termination of weight maintenance intervention (0-104 weeks), and the secondary outcome was the change in body-fat percentage from 0 to 104 weeks.

TAKEAWAY:

• From week 0 to week 104, supervised exercise plus liraglutide led to 5.1 kg lower weight gain (P = .040) and a 2.3%-point greater decrease in body-fat percentage (P = .026) than liraglutide alone.
• During the 1 year after treatment termination (52-104 weeks), those in the liraglutide group regained 6 kg (95% CI, 2.1-10.0) more than those who were in the supervised exercise plus placebo group, and 2.5 kg (95% CI, -1.5 to 6.5) more than those who received supervised exercise plus liraglutide.
• After 1 year of treatment termination (week 104), the supervised exercise plus liraglutide group had significantly higher odds of maintaining a weight loss of ≥ 10% of initial body weight than the liraglutide (odds ratio [OR], 4.2; 95% CI, 1.6-10.8) or placebo (OR, 7.2; 95% CI, 2.4-21.3) groups.
• The combination of exercise and liraglutide also improved physical functioning along with energy and fatigue scores.

IN PRACTICE:

“Future lifestyle-based treatments during obesity pharmacotherapy may further improve body weight and composition outcomes, with an additional focus on strategies and tools to maintain healthy physical activity habits after termination of pharmacotherapy,” the researchers wrote.

SOURCE:

This study, with lead author Simon Birk Kjær Jensen, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark, was published online in eClinicalMedicine.

LIMITATIONS:

Fewer participants from the placebo group took part in this posttreatment study. Across all treatment groups, participants who attended the posttreatment study had a better mean treatment response during the active treatment than those who did not attend.

DISCLOSURES:

The study was funded by the Novo Nordisk Foundation and Helsefonden. Some authors declared participating in advisory boards and receiving research grants and lecture fees from various sources including Novo Nordisk.

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

TOPLINE:

The addition of supervised exercise to obesity pharmacotherapy has shown greater potential for maintaining weight loss and improving body composition after treatment termination than pharmacotherapy alone.

METHODOLOGY:

• Despite significant weight loss achieved with incretin-based obesity pharmacotherapies, their high costs and gastrointestinal adverse events lead to high discontinuation rates with subsequent regaining of weight and body fat.
• Researchers investigated if a strategy involving both exercise and , a -like peptide-1 receptor agonist, was better than either intervention alone in terms of maintaining weight loss and body composition after treatment termination.
• They conducted a 1-year posttreatment analysis of the S-LiTE study, including 109 adults with obesity (age, 18-65 years; body mass index, 32-43) who completed an 8-week low-calorie diet resulting in ≥ 5% weight loss.
• Participants were then randomly allocated to a 52-week weight loss maintenance intervention with either liraglutide or placebo alone or liraglutide or placebo plus supervised exercise.
• The primary outcome was the change in body weight (kg) from randomization to 1 year after the termination of weight maintenance intervention (0-104 weeks), and the secondary outcome was the change in body-fat percentage from 0 to 104 weeks.

TAKEAWAY:

• From week 0 to week 104, supervised exercise plus liraglutide led to 5.1 kg lower weight gain (P = .040) and a 2.3%-point greater decrease in body-fat percentage (P = .026) than liraglutide alone.
• During the 1 year after treatment termination (52-104 weeks), those in the liraglutide group regained 6 kg (95% CI, 2.1-10.0) more than those who were in the supervised exercise plus placebo group, and 2.5 kg (95% CI, -1.5 to 6.5) more than those who received supervised exercise plus liraglutide.
• After 1 year of treatment termination (week 104), the supervised exercise plus liraglutide group had significantly higher odds of maintaining a weight loss of ≥ 10% of initial body weight than the liraglutide (odds ratio [OR], 4.2; 95% CI, 1.6-10.8) or placebo (OR, 7.2; 95% CI, 2.4-21.3) groups.
• The combination of exercise and liraglutide also improved physical functioning along with energy and fatigue scores.

IN PRACTICE:

“Future lifestyle-based treatments during obesity pharmacotherapy may further improve body weight and composition outcomes, with an additional focus on strategies and tools to maintain healthy physical activity habits after termination of pharmacotherapy,” the researchers wrote.

SOURCE:

This study, with lead author Simon Birk Kjær Jensen, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark, was published online in eClinicalMedicine.

LIMITATIONS:

Fewer participants from the placebo group took part in this posttreatment study. Across all treatment groups, participants who attended the posttreatment study had a better mean treatment response during the active treatment than those who did not attend.

DISCLOSURES:

The study was funded by the Novo Nordisk Foundation and Helsefonden. Some authors declared participating in advisory boards and receiving research grants and lecture fees from various sources including Novo Nordisk.

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