Obesity drugs overpriced, change needed to tackle issue

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The lowest available national prices of drugs to treat obesity are up to 20 times higher than the estimated cost of profitable generic versions of the same agents, according to a new analysis.
 

The findings by Jacob Levi, MBBS, and colleagues were published in Obesity.

“Our study highlights the inequality in pricing that exists for effective antiobesity medications, which are largely unaffordable in most countries,” Dr. Levi, from Royal Free Hospital NHS Trust, London, said in a press release.

“We show that these drugs can actually be produced and sold profitably for low prices,” he summarized. “A public health approach that prioritizes improving access to medications should be adopted, instead of allowing companies to maximize profits,” Dr. Levi urged.

Dr. Levi and colleagues studied the oral agents orlistat, naltrexone/bupropion, topiramate/phentermine, and semaglutide, and subcutaneous liraglutide, semaglutide, and tirzepatide (all approved by the U.S. Food and Drug Administration to treat obesity, except for oral semaglutide and subcutaneous tirzepatide, which are not yet approved to treat obesity in the absence of type 2 diabetes).

“Worldwide, more people are dying from diabetes and clinical obesity than HIV, tuberculosis, and malaria combined now,” senior author Andrew Hill, MD, department of pharmacology and therapeutics, University of Liverpool, England, pointed out.
 

We need to repeat the low-cost success story with obesity drugs

“Millions of lives have been saved by treating infectious diseases at low cost in poor countries,” Dr. Hill continued. “Now we need to repeat this medical success story, with mass treatment of diabetes and clinical obesity at low prices.”

However, in an accompanying editorial, Eric A. Finkelstein, MD, and Junxing Chay, PhD, Duke-NUS Medical School, Singapore, maintain that “It would be great if everyone had affordable access to all medicines that might improve their health. Yet that is simply not possible, nor will it ever be.”

“What is truly needed is a better way to ration the health care dollars currently available in efforts to maximize population health. That is the challenge ahead not just for [antiobesity medications] but for all treatments,” they say.

“Greater use of cost-effectiveness analysis and direct negotiations, while maintaining the patent system, represents an appropriate approach for allocating scarce health care resources in the United States and beyond,” they continue.
 

Lowest current patented drug prices vs. estimated generic drug prices

New medications for obesity were highly effective in recent clinical trials, but high prices limit the ability of patients to get these medications, Dr. Levi and colleagues write.

They analyzed prices for obesity drugs in 16 low-, middle-, and high-income countries: Australia, Bangladesh, China, France, Germany, India, Kenya, Morocco, Norway, Peru, Pakistan, South Africa, Turkey, the United Kingdom, the United States, and Vietnam.

The researchers assessed the price of a 30-day supply of each of the studied branded drugs based on the lowest available price (in 2021 U.S. dollars) from multiple online national price databases.

Then they calculated the estimated minimum price of a 30-day supply of a potential generic version of these drugs, which included the cost of the active medicinal ingredients, the excipients (nonactive ingredients), the prefilled injectable device plus needles (for subcutaneous drugs), transportation, 10% profit, and 27% tax on profit.

The national prices of the branded medications for obesity were significantly higher than the estimated minimum prices of potential generic drugs (see Table).



The highest national price for a branded oral drug for obesity vs. the estimated minimum price for a potential generic version was $100 vs. $7 for orlistat, $199 vs. $5 for phentermine/topiramate, and $326 vs. $54 for naltrexone/bupropion, for a 30-day supply.

There was an even greater difference between highest national branded drug price vs. estimated minimum generic drug price for the newer subcutaneously injectable drugs for obesity.

For example, the price of a 30-day course of subcutaneous semaglutide ranged from $804 (United States) to $95 (Turkey), while the estimated minimum potential generic drug price was $40 (which is 20 times lower).

The study was funded by grants from the Make Medicines Affordable/International Treatment Preparedness Coalition and from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Coauthor Francois Venter has reported receiving support from the Bill and Melinda Gates Foundation, U.S. Agency for International Development, Unitaid, SA Medical Research Council, Foundation for Innovative New Diagnostics, the Children’s Investment Fund Foundation, Gilead, ViiV, Mylan, Merck, Adcock Ingram, Aspen, Abbott, Roche, Johnson & Johnson, Sanofi, Virology Education, SA HIV Clinicians Society, and Dira Sengwe. The other authors and Dr. Chay have reported no relevant financial relationships. Dr. Finkelstein has reported receiving support for serving on the WW scientific advisory board and an educational grant unrelated to the present work from Novo Nordisk.

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

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The lowest available national prices of drugs to treat obesity are up to 20 times higher than the estimated cost of profitable generic versions of the same agents, according to a new analysis.
 

The findings by Jacob Levi, MBBS, and colleagues were published in Obesity.

“Our study highlights the inequality in pricing that exists for effective antiobesity medications, which are largely unaffordable in most countries,” Dr. Levi, from Royal Free Hospital NHS Trust, London, said in a press release.

“We show that these drugs can actually be produced and sold profitably for low prices,” he summarized. “A public health approach that prioritizes improving access to medications should be adopted, instead of allowing companies to maximize profits,” Dr. Levi urged.

Dr. Levi and colleagues studied the oral agents orlistat, naltrexone/bupropion, topiramate/phentermine, and semaglutide, and subcutaneous liraglutide, semaglutide, and tirzepatide (all approved by the U.S. Food and Drug Administration to treat obesity, except for oral semaglutide and subcutaneous tirzepatide, which are not yet approved to treat obesity in the absence of type 2 diabetes).

“Worldwide, more people are dying from diabetes and clinical obesity than HIV, tuberculosis, and malaria combined now,” senior author Andrew Hill, MD, department of pharmacology and therapeutics, University of Liverpool, England, pointed out.
 

We need to repeat the low-cost success story with obesity drugs

“Millions of lives have been saved by treating infectious diseases at low cost in poor countries,” Dr. Hill continued. “Now we need to repeat this medical success story, with mass treatment of diabetes and clinical obesity at low prices.”

However, in an accompanying editorial, Eric A. Finkelstein, MD, and Junxing Chay, PhD, Duke-NUS Medical School, Singapore, maintain that “It would be great if everyone had affordable access to all medicines that might improve their health. Yet that is simply not possible, nor will it ever be.”

“What is truly needed is a better way to ration the health care dollars currently available in efforts to maximize population health. That is the challenge ahead not just for [antiobesity medications] but for all treatments,” they say.

“Greater use of cost-effectiveness analysis and direct negotiations, while maintaining the patent system, represents an appropriate approach for allocating scarce health care resources in the United States and beyond,” they continue.
 

Lowest current patented drug prices vs. estimated generic drug prices

New medications for obesity were highly effective in recent clinical trials, but high prices limit the ability of patients to get these medications, Dr. Levi and colleagues write.

They analyzed prices for obesity drugs in 16 low-, middle-, and high-income countries: Australia, Bangladesh, China, France, Germany, India, Kenya, Morocco, Norway, Peru, Pakistan, South Africa, Turkey, the United Kingdom, the United States, and Vietnam.

The researchers assessed the price of a 30-day supply of each of the studied branded drugs based on the lowest available price (in 2021 U.S. dollars) from multiple online national price databases.

Then they calculated the estimated minimum price of a 30-day supply of a potential generic version of these drugs, which included the cost of the active medicinal ingredients, the excipients (nonactive ingredients), the prefilled injectable device plus needles (for subcutaneous drugs), transportation, 10% profit, and 27% tax on profit.

The national prices of the branded medications for obesity were significantly higher than the estimated minimum prices of potential generic drugs (see Table).



The highest national price for a branded oral drug for obesity vs. the estimated minimum price for a potential generic version was $100 vs. $7 for orlistat, $199 vs. $5 for phentermine/topiramate, and $326 vs. $54 for naltrexone/bupropion, for a 30-day supply.

There was an even greater difference between highest national branded drug price vs. estimated minimum generic drug price for the newer subcutaneously injectable drugs for obesity.

For example, the price of a 30-day course of subcutaneous semaglutide ranged from $804 (United States) to $95 (Turkey), while the estimated minimum potential generic drug price was $40 (which is 20 times lower).

The study was funded by grants from the Make Medicines Affordable/International Treatment Preparedness Coalition and from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Coauthor Francois Venter has reported receiving support from the Bill and Melinda Gates Foundation, U.S. Agency for International Development, Unitaid, SA Medical Research Council, Foundation for Innovative New Diagnostics, the Children’s Investment Fund Foundation, Gilead, ViiV, Mylan, Merck, Adcock Ingram, Aspen, Abbott, Roche, Johnson & Johnson, Sanofi, Virology Education, SA HIV Clinicians Society, and Dira Sengwe. The other authors and Dr. Chay have reported no relevant financial relationships. Dr. Finkelstein has reported receiving support for serving on the WW scientific advisory board and an educational grant unrelated to the present work from Novo Nordisk.

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

 

The lowest available national prices of drugs to treat obesity are up to 20 times higher than the estimated cost of profitable generic versions of the same agents, according to a new analysis.
 

The findings by Jacob Levi, MBBS, and colleagues were published in Obesity.

“Our study highlights the inequality in pricing that exists for effective antiobesity medications, which are largely unaffordable in most countries,” Dr. Levi, from Royal Free Hospital NHS Trust, London, said in a press release.

“We show that these drugs can actually be produced and sold profitably for low prices,” he summarized. “A public health approach that prioritizes improving access to medications should be adopted, instead of allowing companies to maximize profits,” Dr. Levi urged.

Dr. Levi and colleagues studied the oral agents orlistat, naltrexone/bupropion, topiramate/phentermine, and semaglutide, and subcutaneous liraglutide, semaglutide, and tirzepatide (all approved by the U.S. Food and Drug Administration to treat obesity, except for oral semaglutide and subcutaneous tirzepatide, which are not yet approved to treat obesity in the absence of type 2 diabetes).

“Worldwide, more people are dying from diabetes and clinical obesity than HIV, tuberculosis, and malaria combined now,” senior author Andrew Hill, MD, department of pharmacology and therapeutics, University of Liverpool, England, pointed out.
 

We need to repeat the low-cost success story with obesity drugs

“Millions of lives have been saved by treating infectious diseases at low cost in poor countries,” Dr. Hill continued. “Now we need to repeat this medical success story, with mass treatment of diabetes and clinical obesity at low prices.”

However, in an accompanying editorial, Eric A. Finkelstein, MD, and Junxing Chay, PhD, Duke-NUS Medical School, Singapore, maintain that “It would be great if everyone had affordable access to all medicines that might improve their health. Yet that is simply not possible, nor will it ever be.”

“What is truly needed is a better way to ration the health care dollars currently available in efforts to maximize population health. That is the challenge ahead not just for [antiobesity medications] but for all treatments,” they say.

“Greater use of cost-effectiveness analysis and direct negotiations, while maintaining the patent system, represents an appropriate approach for allocating scarce health care resources in the United States and beyond,” they continue.
 

Lowest current patented drug prices vs. estimated generic drug prices

New medications for obesity were highly effective in recent clinical trials, but high prices limit the ability of patients to get these medications, Dr. Levi and colleagues write.

They analyzed prices for obesity drugs in 16 low-, middle-, and high-income countries: Australia, Bangladesh, China, France, Germany, India, Kenya, Morocco, Norway, Peru, Pakistan, South Africa, Turkey, the United Kingdom, the United States, and Vietnam.

The researchers assessed the price of a 30-day supply of each of the studied branded drugs based on the lowest available price (in 2021 U.S. dollars) from multiple online national price databases.

Then they calculated the estimated minimum price of a 30-day supply of a potential generic version of these drugs, which included the cost of the active medicinal ingredients, the excipients (nonactive ingredients), the prefilled injectable device plus needles (for subcutaneous drugs), transportation, 10% profit, and 27% tax on profit.

The national prices of the branded medications for obesity were significantly higher than the estimated minimum prices of potential generic drugs (see Table).



The highest national price for a branded oral drug for obesity vs. the estimated minimum price for a potential generic version was $100 vs. $7 for orlistat, $199 vs. $5 for phentermine/topiramate, and $326 vs. $54 for naltrexone/bupropion, for a 30-day supply.

There was an even greater difference between highest national branded drug price vs. estimated minimum generic drug price for the newer subcutaneously injectable drugs for obesity.

For example, the price of a 30-day course of subcutaneous semaglutide ranged from $804 (United States) to $95 (Turkey), while the estimated minimum potential generic drug price was $40 (which is 20 times lower).

The study was funded by grants from the Make Medicines Affordable/International Treatment Preparedness Coalition and from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Coauthor Francois Venter has reported receiving support from the Bill and Melinda Gates Foundation, U.S. Agency for International Development, Unitaid, SA Medical Research Council, Foundation for Innovative New Diagnostics, the Children’s Investment Fund Foundation, Gilead, ViiV, Mylan, Merck, Adcock Ingram, Aspen, Abbott, Roche, Johnson & Johnson, Sanofi, Virology Education, SA HIV Clinicians Society, and Dira Sengwe. The other authors and Dr. Chay have reported no relevant financial relationships. Dr. Finkelstein has reported receiving support for serving on the WW scientific advisory board and an educational grant unrelated to the present work from Novo Nordisk.

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

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Tirzepatide scores win in second obesity trial, SURMOUNT-2

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The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.

The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.

Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.

Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.

These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
 

SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1

SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.

The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.

For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.

For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.

In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.

So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.

Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.

Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.

SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
 

 

 

More SURMOUNT-2 results at ADA in June

Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.

Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.

Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.

SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.

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

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The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.

The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.

Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.

Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.

These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
 

SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1

SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.

The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.

For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.

For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.

In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.

So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.

Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.

Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.

SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
 

 

 

More SURMOUNT-2 results at ADA in June

Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.

Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.

Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.

SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.

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

The “twincretin” tirzepatide (Mounjaro) has proven successful in SURMOUNT-2, the second pivotal trial for the drug as an antiobesity agent, according to top-line results reported April 27 by tirzepatide’s manufacturer, Lilly, in a press release. The company reveals that tirzepatide achieved both of its primary endpoints in the trial, as well as all its key secondary endpoints.

The findings pave the way for tirzepatide to likely receive Food and Drug Administration approval as a treatment for obesity, perhaps before the end of 2023.

Tirzepatide received FDA approval in May 2022 for the treatment of type 2 diabetes in adults, under the brand name Mounjaro, and some people have already been using it off-label to treat obesity.

Tirzepatide is a dual glucagonlike peptide–1 (GLP-1) agonist and glucose-dependent insulinotropic polypeptide agonist. Several GLP-1 receptor agonists are already approved in the United States, including semaglutide, a once-weekly injection, which is approved as Wegovy for patients with obesity and as Ozempic for treatment of type 2 diabetes.

These agents have been incredibly popular among celebrity influencers, and with use of the #Ozempic hashtag and others on social media, this has led to unprecedented use of these products for weight loss, often among those who do not even have obesity or type 2 diabetes. Subsequently, patients with type 2 diabetes and obesity who need them have often struggled to obtain them, owing to shortages following this phenomenon.
 

SURMOUNT-2: Weight loss around 15%, less than seen in SURMOUNT-1

SURMOUNT-2 enrolled 938 adults with overweight or obesity and type 2 diabetes and had dual primary endpoints that both focused on weight loss, compared with placebo.

The first completed pivotal trial of tirzepatide for weight loss, SURMOUNT-1, enrolled people with overweight or obesity but no diabetes and had its main results reported in 2022. At the time, the weight loss achieved with tirzepatide, was described as “unprecedented,” with those given the highest dose in that trial (15 mg subcutaneously per week) losing an average of 20%-22% of body weight over 72 weeks, depending on the specific statistical analysis used.

For SURMOUNT-2’s first primary endpoint, 72 weeks of weekly subcutaneous injections with tirzepatide at dosages of 10 mg or 15 mg led to an average weight loss from baseline of 13.4% and 15.7%, respectively, compared with an average loss of 3.3% from baseline in the placebo-treated control arm.

For the second primary endpoint, 81.6% of people on the 10-mg dose and 86.4% on the 15-mg dose achieved at least 5% weight loss from baseline, compared with 30.5% of controls who had at least 5% weight loss from baseline.

In one key secondary endpoint, tirzepatide at dosages of 10 mg or 15 mg weekly produced at least a 15% cut in weight from baseline in 41.4% and 51.8% of participants, respectively, compared with a 2.6% rate of this endpoint in the placebo controls.

So the extent of weight loss seen in in SURMOUNT-2 was somewhat less than was reported in SURMOUNT-1, a finding consistent with many prior studies of incretin-based weight-loss agents, which seem to pack a more potent weight-loss punch in people without type 2 diabetes.

Lilly did not specifically report the treatment effect of tirzepatide on hemoglobin A1c in SURMOUNT-2, only saying that the effect was similar to what had been seen in the series of five SURPASS trials that led to the approval of tirzepatide for type 2 diabetes.

Lilly also reported that the safety profile of tirzepatide in SURMOUNT-2 generally matched what was seen in SURMOUNT-1 as well as in the SURPASS trials. The most common adverse events in SURMOUNT-2 involved gastrointestinal symptoms, such as nausea, diarrhea, and vomiting; these were generally mild to moderate in severity and clustered during the dose-escalation phase at the start of treatment. Treatment discontinuations caused by adverse effects were 3.8% on the 10-mg dosage, 7.4% on the 15-mg dosage, and 3.8% on placebo.

SURMOUNT-2 enrolled patients in the United States, Puerto Rico, and five other countries. All participants also received interventions designed to reduce their calorie intake and increase their physical activity.
 

 

 

More SURMOUNT-2 results at ADA in June

Lilly also announced that researchers would report more complete results from SURMOUNT-2 at the 2023 scientific sessions of the American Diabetes Association, being held in San Diego in late June, and publish the findings in a major medical journal.

Results from two additional phase 3 trials of tirzepatide in people with overweight or obesity, SURMOUNT-3 and SURMOUNT-4, are expected later in 2023.

Lilly started an application to the FDA for an indication for weight loss in October 2022 under a fast track designation by the agency, and the data collected in SURMOUNT-2 are expected to complete this application, which would then be subject to an FDA decision within about 6 months. Lilly said in its April 27 press release that it anticipates an FDA decision on this application may occur before the end of 2023.

SURMOUNT-2 and all of the other tirzepatide trials were sponsored by Lilly.

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

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BMI is a flawed measure of obesity. What are alternatives?

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“BMI is trash. Full stop.” This controversial tweet, which received thousands of likes and retweets, was cited in a recent article by one doctor on when physicians might stop using body mass index (BMI) to diagnose obesity.

BMI has for years been the consensus default method for assessing whether a person is overweight or has obesity, and is still widely used as the gatekeeper metric for treatment eligibility for certain weight-loss agents and bariatric surgery.

But growing appreciation of the limitations of BMI is causing many clinicians to consider alternative measures of obesity that can better assess both the amount of adiposity as well as its body location, an important determinant of the cardiometabolic consequences of fat.

Alternative metrics include waist circumference and/or waist-to-height ratio (WHtR); imaging methods such as CT, MRI, and dual-energy x-ray absorptiometry (DXA); and bioelectrical impedance to assess fat volume and location. All have made some inroads on the tight grip BMI has had on obesity assessment.

Chances are, however, that BMI will not fade away anytime soon given how entrenched it has become in clinical practice and for insurance coverage, as well as its relative simplicity and precision.

“BMI is embedded in a wide range of guidelines on the use of medications and surgery. It’s embedded in Food and Drug Administration regulations and for billing and insurance coverage. It would take extremely strong data and years of work to undo the infrastructure built around BMI and replace it with something else. I don’t see that happening [anytime soon],” commented Daniel H. Bessesen, MD, a professor at the University of Colorado at Denver, Aurora, and chief of endocrinology for Denver Health.

“It would be almost impossible to replace all the studies that have used BMI with investigations using some other measure,” he said.
 

BMI Is ‘imperfect’

The entrenched position of BMI as the go-to metric doesn’t keep detractors from weighing in. As noted in a commentary on current clinical challenges surrounding obesity recently published in Annals of Internal Medicine, the journal’s editor-in-chief, Christine Laine, MD, and senior deputy editor Christina C. Wee, MD, listed six top issues clinicians must deal with, one of which, they say, is the need for a better measure of obesity than BMI.

“Unfortunately, BMI is an imperfect measure of body composition that differs with ethnicity, sex, body frame, and muscle mass,” noted Dr. Laine and Dr. Wee.

BMI is based on a person’s weight in kilograms divided by the square of their height in meters. A “healthy” BMI is between 18.5 and 24.9 kg/m2, overweight is 25-29.9, and 30 or greater is considered to represent obesity. However, certain ethnic groups have lower cutoffs for overweight or obesity because of evidence that such individuals can be at higher risk of obesity-related comorbidities at lower BMIs.

“BMI was chosen as the initial screening tool [for obesity] not because anyone thought it was perfect or the best measure but because of its simplicity. All you need is height, weight, and a calculator,” Dr. Wee said in an interview.

Numerous online calculators are available, including one from the Centers for Disease Control and Prevention where height in feet and inches and weight in pounds can be entered to generate the BMI.

BMI is also inherently limited by being “a proxy for adiposity” and not a direct measure, added Dr. Wee, who is also director of the Obesity Research Program of Beth Israel Deaconess Medical Center, Boston.

As such, BMI can’t distinguish between fat and muscle because it relies on weight only to gauge adiposity, noted Tiffany Powell-Wiley, MD, an obesity researcher at the National Heart, Lung, and Blood Institute in Bethesda, Md. Another shortcoming of BMI is that it “is good for distinguishing population-level risk for cardiovascular disease and other chronic diseases, but it does not help as much for distinguishing risk at an individual level,” she said in an interview.

These and other drawbacks have prompted researchers to look for other useful metrics. WHtR, for example, has recently made headway as a potential BMI alternative or complement.
 

 

 

The case for WHtR

Concern about overreliance on BMI despite its limitations is not new. In 2015, an American Heart Association scientific statement from the group’s Obesity Committee concluded that “BMI alone, even with lower thresholds, is a useful but not an ideal tool for identification of obesity or assessment of cardiovascular risk,” especially for people from Asian, Black, Hispanic, and Pacific Islander populations.

The writing panel also recommended that clinicians measure waist circumference annually and use that information along with BMI “to better gauge cardiovascular risk in diverse populations.”

Momentum for moving beyond BMI alone has continued to build following the AHA statement.

In September 2022, the National Institute for Health and Care Excellence, which sets policies for the United Kingdom’s National Health Service, revised its guidancefor assessment and management of people with obesity. The updated guidance recommends that when clinicians assess “adults with BMI below 35 kg/m2, measure and use their WHtR, as well as their BMI, as a practical estimate of central adiposity and use these measurements to help to assess and predict health risks.”

NICE released an extensive literature review with the revision, and based on the evidence, said that “using waist-to-height ratio as well as BMI would help give a practical estimate of central adiposity in adults with BMI under 35 kg/m2. This would in turn help professionals assess and predict health risks.”

However, the review added that, “because people with a BMI over 35 kg/m2 are always likely to have a high WHtR, the committee recognized that it may not be a useful addition for predicting health risks in this group.” The 2022 NICE review also said that it is “important to estimate central adiposity when assessing future health risks, including for people whose BMI is in the healthy-weight category.”

This new emphasis by NICE on measuring and using WHtR as part of obesity assessment “represents an important change in population health policy,” commented Dr. Powell-Wiley. “I expect more professional organizations will endorse use of waist circumference or waist-to-height ratio now that NICE has taken this step,” she predicted.

Waist circumference and WHtR may become standard measures of adiposity in clinical practice over the next 5-10 years.

The recent move by NICE to highlight a complementary role for WHtR “is another acknowledgment that BMI is an imperfect tool for stratifying cardiometabolic risk in a diverse population, especially in people with lower BMIs” because of its variability, commented Jamie Almandoz, MD, medical director of the weight wellness program at UT Southwestern Medical Center, Dallas.
 

WHtR vs. BMI

Another recent step forward for WHtR came with the publication of a post hoc analysis of data collected in the PARADIGM-HF trial, a study that had the primary purpose of comparing two medications for improving outcomes in more than 8,000 patients with heart failure with reduced ejection fraction.

The new analysis showed that “two indices that incorporate waist circumference and height, but not weight, showed a clearer association between greater adiposity and a higher risk of heart failure hospitalization,” compared with BMI.

WHtR was one of the two indices identified as being a better correlate for the adverse effect of excess adiposity compared with BMI.

The authors of the post hoc analysis did not design their analysis to compare WHtR with BMI. Instead, their goal was to better understand what’s known as the “obesity paradox” in people with heart failure with reduced ejection fraction: The recurring observation that, when these patients with heart failure have lower BMIs they fare worse, with higher rates of mortality and adverse cardiovascular outcomes, compared with patients with higher BMIs.

The new analysis showed that this paradox disappeared when WHtR was substituted for BMI as the obesity metric.

This “provides meaningful data about the superiority of WHtR, compared with BMI, for predicting heart failure outcomes,” said Dr. Powell-Wiley, although she cautioned that the analysis was limited by scant data in diverse populations and did not look at other important cardiovascular disease outcomes. While Dr. Powell-Wiley does not think that WHtR needs assessment in a prospective, controlled trial, she called for analysis of pooled prospective studies with more diverse populations to better document the advantages of WHtR over BMI.

The PARADIGM-HF post hoc analysis shows again how flawed BMI is for health assessment and the relative importance of an individualized understanding of a person’s body composition, Dr. Almandoz said in an interview. “As we collect more data, there is increasing awareness of how imperfect BMI is.”
 

 

 

Measuring waist circumference is tricky

Although WHtR looks promising as a substitute for or add-on to BMI, it has its own limitations, particularly the challenge of accurately measuring waist circumference.

Measuring waist circumference “not only takes more time but requires the assessor to be well trained about where to put the tape measure and making sure it’s measured at the same place each time,” even when different people take serial measurements from individual patients, noted Dr. Wee. Determining waist circumference can also be technically difficult when done on larger people, she added, and collectively these challenges make waist circumference “less reproducible from measurement to measurement.”

“It’s relatively clear how to standardize measurement of weight and height, but there is a huge amount of variability when the waist is measured,” agreed Dr. Almandoz. “And waist circumference also differs by ethnicity, race, sex, and body frame. There are significant differences in waist circumference levels that associate with increased health risks” between, for example, White and South Asian people.

Another limitation of waist circumference and WHtR is that they “cannot differentiate between visceral and abdominal subcutaneous adipose tissue, which are vastly different regarding cardiometabolic risk, commented Ian Neeland, MD, director of cardiovascular prevention at the University Hospitals Harrington Heart & Vascular Institute, Cleveland.
 

The imaging option

“Waist-to-height ratio is not the ultimate answer,” Dr. Neeland said in an interview. He instead endorsed “advanced imaging for body fat distribution,” such as CT or MRI scans, as his pick for what should be the standard obesity metric, “given that it is much more specific and actionable for both risk assessment and response to therapy. I expect slow but steady advancements that move away from BMI cutoffs, for example for bariatric surgery, given that BMI is an imprecise and crude tool.”

But although imaging with methods like CT and MRI may provide the best accuracy and precision for tracking the volume of a person’s cardiometabolically dangerous fat, they are also hampered by relatively high cost and, for CT and DXA, the issue of radiation exposure.

“CT, MRI, and DXA scans give more in-depth assessment of body composition, but should we expose people to the radiation and the cost?” Dr. Almandoz wondered.

“Height, weight, and waist circumference cost nothing to obtain,” creating a big relative disadvantage for imaging, said Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow.

“Data would need to show that imaging gives clinicians substantially more information about future risk” to justify its price, Dr. Sattar emphasized.
 

BMI’s limits mean adding on

Regardless of whichever alternatives to BMI end up getting used most, experts generally agree that BMI alone is looking increasingly inadequate.

“Over the next 5 years, BMI will come to be seen as a screening tool that categorizes people into general risk groups” that also needs “other metrics and variables, such as age, race, ethnicity, family history, blood glucose, and blood pressure to better describe health risk in an individual,” predicted Dr. Bessesen.

The endorsement of WHtR by NICE “will lead to more research into how to incorporate WHtR into routine practice. We need more evidence to translate what NICE said into practice,” said Dr. Sattar. “I don’t think we’ll see a shift away from BMI, but we’ll add alternative measures that are particularly useful in certain patients.”

“Because we live in diverse societies, we need to individualize risk assessment and couple that with technology that makes analysis of body composition more accessible,” agreed Dr. Almandoz. He noted that the UT Southwestern weight wellness program where he practices has, for about the past decade, routinely collected waist circumference and bioelectrical impedance data as well as BMI on all people seen in the practice for obesity concerns. Making these additional measurements on a routine basis also helps strengthen patient engagement.

“We get into trouble when we make rigid health policy and clinical decisions based on BMI alone without looking at the patient holistically,” said Dr. Wee. “Patients are more than arbitrary numbers, and clinicians should make clinical decisions based on the totality of evidence for each individual patient.”

Dr. Bessesen, Dr. Wee, Dr. Powell-Wiley, and Dr. Almandoz reported no relevant financial relationships. Dr. Neeland has reported being a consultant for Merck. Dr. Sattar has reported being a consultant or speaker for Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, and Sanofi.

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

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“BMI is trash. Full stop.” This controversial tweet, which received thousands of likes and retweets, was cited in a recent article by one doctor on when physicians might stop using body mass index (BMI) to diagnose obesity.

BMI has for years been the consensus default method for assessing whether a person is overweight or has obesity, and is still widely used as the gatekeeper metric for treatment eligibility for certain weight-loss agents and bariatric surgery.

But growing appreciation of the limitations of BMI is causing many clinicians to consider alternative measures of obesity that can better assess both the amount of adiposity as well as its body location, an important determinant of the cardiometabolic consequences of fat.

Alternative metrics include waist circumference and/or waist-to-height ratio (WHtR); imaging methods such as CT, MRI, and dual-energy x-ray absorptiometry (DXA); and bioelectrical impedance to assess fat volume and location. All have made some inroads on the tight grip BMI has had on obesity assessment.

Chances are, however, that BMI will not fade away anytime soon given how entrenched it has become in clinical practice and for insurance coverage, as well as its relative simplicity and precision.

“BMI is embedded in a wide range of guidelines on the use of medications and surgery. It’s embedded in Food and Drug Administration regulations and for billing and insurance coverage. It would take extremely strong data and years of work to undo the infrastructure built around BMI and replace it with something else. I don’t see that happening [anytime soon],” commented Daniel H. Bessesen, MD, a professor at the University of Colorado at Denver, Aurora, and chief of endocrinology for Denver Health.

“It would be almost impossible to replace all the studies that have used BMI with investigations using some other measure,” he said.
 

BMI Is ‘imperfect’

The entrenched position of BMI as the go-to metric doesn’t keep detractors from weighing in. As noted in a commentary on current clinical challenges surrounding obesity recently published in Annals of Internal Medicine, the journal’s editor-in-chief, Christine Laine, MD, and senior deputy editor Christina C. Wee, MD, listed six top issues clinicians must deal with, one of which, they say, is the need for a better measure of obesity than BMI.

“Unfortunately, BMI is an imperfect measure of body composition that differs with ethnicity, sex, body frame, and muscle mass,” noted Dr. Laine and Dr. Wee.

BMI is based on a person’s weight in kilograms divided by the square of their height in meters. A “healthy” BMI is between 18.5 and 24.9 kg/m2, overweight is 25-29.9, and 30 or greater is considered to represent obesity. However, certain ethnic groups have lower cutoffs for overweight or obesity because of evidence that such individuals can be at higher risk of obesity-related comorbidities at lower BMIs.

“BMI was chosen as the initial screening tool [for obesity] not because anyone thought it was perfect or the best measure but because of its simplicity. All you need is height, weight, and a calculator,” Dr. Wee said in an interview.

Numerous online calculators are available, including one from the Centers for Disease Control and Prevention where height in feet and inches and weight in pounds can be entered to generate the BMI.

BMI is also inherently limited by being “a proxy for adiposity” and not a direct measure, added Dr. Wee, who is also director of the Obesity Research Program of Beth Israel Deaconess Medical Center, Boston.

As such, BMI can’t distinguish between fat and muscle because it relies on weight only to gauge adiposity, noted Tiffany Powell-Wiley, MD, an obesity researcher at the National Heart, Lung, and Blood Institute in Bethesda, Md. Another shortcoming of BMI is that it “is good for distinguishing population-level risk for cardiovascular disease and other chronic diseases, but it does not help as much for distinguishing risk at an individual level,” she said in an interview.

These and other drawbacks have prompted researchers to look for other useful metrics. WHtR, for example, has recently made headway as a potential BMI alternative or complement.
 

 

 

The case for WHtR

Concern about overreliance on BMI despite its limitations is not new. In 2015, an American Heart Association scientific statement from the group’s Obesity Committee concluded that “BMI alone, even with lower thresholds, is a useful but not an ideal tool for identification of obesity or assessment of cardiovascular risk,” especially for people from Asian, Black, Hispanic, and Pacific Islander populations.

The writing panel also recommended that clinicians measure waist circumference annually and use that information along with BMI “to better gauge cardiovascular risk in diverse populations.”

Momentum for moving beyond BMI alone has continued to build following the AHA statement.

In September 2022, the National Institute for Health and Care Excellence, which sets policies for the United Kingdom’s National Health Service, revised its guidancefor assessment and management of people with obesity. The updated guidance recommends that when clinicians assess “adults with BMI below 35 kg/m2, measure and use their WHtR, as well as their BMI, as a practical estimate of central adiposity and use these measurements to help to assess and predict health risks.”

NICE released an extensive literature review with the revision, and based on the evidence, said that “using waist-to-height ratio as well as BMI would help give a practical estimate of central adiposity in adults with BMI under 35 kg/m2. This would in turn help professionals assess and predict health risks.”

However, the review added that, “because people with a BMI over 35 kg/m2 are always likely to have a high WHtR, the committee recognized that it may not be a useful addition for predicting health risks in this group.” The 2022 NICE review also said that it is “important to estimate central adiposity when assessing future health risks, including for people whose BMI is in the healthy-weight category.”

This new emphasis by NICE on measuring and using WHtR as part of obesity assessment “represents an important change in population health policy,” commented Dr. Powell-Wiley. “I expect more professional organizations will endorse use of waist circumference or waist-to-height ratio now that NICE has taken this step,” she predicted.

Waist circumference and WHtR may become standard measures of adiposity in clinical practice over the next 5-10 years.

The recent move by NICE to highlight a complementary role for WHtR “is another acknowledgment that BMI is an imperfect tool for stratifying cardiometabolic risk in a diverse population, especially in people with lower BMIs” because of its variability, commented Jamie Almandoz, MD, medical director of the weight wellness program at UT Southwestern Medical Center, Dallas.
 

WHtR vs. BMI

Another recent step forward for WHtR came with the publication of a post hoc analysis of data collected in the PARADIGM-HF trial, a study that had the primary purpose of comparing two medications for improving outcomes in more than 8,000 patients with heart failure with reduced ejection fraction.

The new analysis showed that “two indices that incorporate waist circumference and height, but not weight, showed a clearer association between greater adiposity and a higher risk of heart failure hospitalization,” compared with BMI.

WHtR was one of the two indices identified as being a better correlate for the adverse effect of excess adiposity compared with BMI.

The authors of the post hoc analysis did not design their analysis to compare WHtR with BMI. Instead, their goal was to better understand what’s known as the “obesity paradox” in people with heart failure with reduced ejection fraction: The recurring observation that, when these patients with heart failure have lower BMIs they fare worse, with higher rates of mortality and adverse cardiovascular outcomes, compared with patients with higher BMIs.

The new analysis showed that this paradox disappeared when WHtR was substituted for BMI as the obesity metric.

This “provides meaningful data about the superiority of WHtR, compared with BMI, for predicting heart failure outcomes,” said Dr. Powell-Wiley, although she cautioned that the analysis was limited by scant data in diverse populations and did not look at other important cardiovascular disease outcomes. While Dr. Powell-Wiley does not think that WHtR needs assessment in a prospective, controlled trial, she called for analysis of pooled prospective studies with more diverse populations to better document the advantages of WHtR over BMI.

The PARADIGM-HF post hoc analysis shows again how flawed BMI is for health assessment and the relative importance of an individualized understanding of a person’s body composition, Dr. Almandoz said in an interview. “As we collect more data, there is increasing awareness of how imperfect BMI is.”
 

 

 

Measuring waist circumference is tricky

Although WHtR looks promising as a substitute for or add-on to BMI, it has its own limitations, particularly the challenge of accurately measuring waist circumference.

Measuring waist circumference “not only takes more time but requires the assessor to be well trained about where to put the tape measure and making sure it’s measured at the same place each time,” even when different people take serial measurements from individual patients, noted Dr. Wee. Determining waist circumference can also be technically difficult when done on larger people, she added, and collectively these challenges make waist circumference “less reproducible from measurement to measurement.”

“It’s relatively clear how to standardize measurement of weight and height, but there is a huge amount of variability when the waist is measured,” agreed Dr. Almandoz. “And waist circumference also differs by ethnicity, race, sex, and body frame. There are significant differences in waist circumference levels that associate with increased health risks” between, for example, White and South Asian people.

Another limitation of waist circumference and WHtR is that they “cannot differentiate between visceral and abdominal subcutaneous adipose tissue, which are vastly different regarding cardiometabolic risk, commented Ian Neeland, MD, director of cardiovascular prevention at the University Hospitals Harrington Heart & Vascular Institute, Cleveland.
 

The imaging option

“Waist-to-height ratio is not the ultimate answer,” Dr. Neeland said in an interview. He instead endorsed “advanced imaging for body fat distribution,” such as CT or MRI scans, as his pick for what should be the standard obesity metric, “given that it is much more specific and actionable for both risk assessment and response to therapy. I expect slow but steady advancements that move away from BMI cutoffs, for example for bariatric surgery, given that BMI is an imprecise and crude tool.”

But although imaging with methods like CT and MRI may provide the best accuracy and precision for tracking the volume of a person’s cardiometabolically dangerous fat, they are also hampered by relatively high cost and, for CT and DXA, the issue of radiation exposure.

“CT, MRI, and DXA scans give more in-depth assessment of body composition, but should we expose people to the radiation and the cost?” Dr. Almandoz wondered.

“Height, weight, and waist circumference cost nothing to obtain,” creating a big relative disadvantage for imaging, said Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow.

“Data would need to show that imaging gives clinicians substantially more information about future risk” to justify its price, Dr. Sattar emphasized.
 

BMI’s limits mean adding on

Regardless of whichever alternatives to BMI end up getting used most, experts generally agree that BMI alone is looking increasingly inadequate.

“Over the next 5 years, BMI will come to be seen as a screening tool that categorizes people into general risk groups” that also needs “other metrics and variables, such as age, race, ethnicity, family history, blood glucose, and blood pressure to better describe health risk in an individual,” predicted Dr. Bessesen.

The endorsement of WHtR by NICE “will lead to more research into how to incorporate WHtR into routine practice. We need more evidence to translate what NICE said into practice,” said Dr. Sattar. “I don’t think we’ll see a shift away from BMI, but we’ll add alternative measures that are particularly useful in certain patients.”

“Because we live in diverse societies, we need to individualize risk assessment and couple that with technology that makes analysis of body composition more accessible,” agreed Dr. Almandoz. He noted that the UT Southwestern weight wellness program where he practices has, for about the past decade, routinely collected waist circumference and bioelectrical impedance data as well as BMI on all people seen in the practice for obesity concerns. Making these additional measurements on a routine basis also helps strengthen patient engagement.

“We get into trouble when we make rigid health policy and clinical decisions based on BMI alone without looking at the patient holistically,” said Dr. Wee. “Patients are more than arbitrary numbers, and clinicians should make clinical decisions based on the totality of evidence for each individual patient.”

Dr. Bessesen, Dr. Wee, Dr. Powell-Wiley, and Dr. Almandoz reported no relevant financial relationships. Dr. Neeland has reported being a consultant for Merck. Dr. Sattar has reported being a consultant or speaker for Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, and Sanofi.

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

“BMI is trash. Full stop.” This controversial tweet, which received thousands of likes and retweets, was cited in a recent article by one doctor on when physicians might stop using body mass index (BMI) to diagnose obesity.

BMI has for years been the consensus default method for assessing whether a person is overweight or has obesity, and is still widely used as the gatekeeper metric for treatment eligibility for certain weight-loss agents and bariatric surgery.

But growing appreciation of the limitations of BMI is causing many clinicians to consider alternative measures of obesity that can better assess both the amount of adiposity as well as its body location, an important determinant of the cardiometabolic consequences of fat.

Alternative metrics include waist circumference and/or waist-to-height ratio (WHtR); imaging methods such as CT, MRI, and dual-energy x-ray absorptiometry (DXA); and bioelectrical impedance to assess fat volume and location. All have made some inroads on the tight grip BMI has had on obesity assessment.

Chances are, however, that BMI will not fade away anytime soon given how entrenched it has become in clinical practice and for insurance coverage, as well as its relative simplicity and precision.

“BMI is embedded in a wide range of guidelines on the use of medications and surgery. It’s embedded in Food and Drug Administration regulations and for billing and insurance coverage. It would take extremely strong data and years of work to undo the infrastructure built around BMI and replace it with something else. I don’t see that happening [anytime soon],” commented Daniel H. Bessesen, MD, a professor at the University of Colorado at Denver, Aurora, and chief of endocrinology for Denver Health.

“It would be almost impossible to replace all the studies that have used BMI with investigations using some other measure,” he said.
 

BMI Is ‘imperfect’

The entrenched position of BMI as the go-to metric doesn’t keep detractors from weighing in. As noted in a commentary on current clinical challenges surrounding obesity recently published in Annals of Internal Medicine, the journal’s editor-in-chief, Christine Laine, MD, and senior deputy editor Christina C. Wee, MD, listed six top issues clinicians must deal with, one of which, they say, is the need for a better measure of obesity than BMI.

“Unfortunately, BMI is an imperfect measure of body composition that differs with ethnicity, sex, body frame, and muscle mass,” noted Dr. Laine and Dr. Wee.

BMI is based on a person’s weight in kilograms divided by the square of their height in meters. A “healthy” BMI is between 18.5 and 24.9 kg/m2, overweight is 25-29.9, and 30 or greater is considered to represent obesity. However, certain ethnic groups have lower cutoffs for overweight or obesity because of evidence that such individuals can be at higher risk of obesity-related comorbidities at lower BMIs.

“BMI was chosen as the initial screening tool [for obesity] not because anyone thought it was perfect or the best measure but because of its simplicity. All you need is height, weight, and a calculator,” Dr. Wee said in an interview.

Numerous online calculators are available, including one from the Centers for Disease Control and Prevention where height in feet and inches and weight in pounds can be entered to generate the BMI.

BMI is also inherently limited by being “a proxy for adiposity” and not a direct measure, added Dr. Wee, who is also director of the Obesity Research Program of Beth Israel Deaconess Medical Center, Boston.

As such, BMI can’t distinguish between fat and muscle because it relies on weight only to gauge adiposity, noted Tiffany Powell-Wiley, MD, an obesity researcher at the National Heart, Lung, and Blood Institute in Bethesda, Md. Another shortcoming of BMI is that it “is good for distinguishing population-level risk for cardiovascular disease and other chronic diseases, but it does not help as much for distinguishing risk at an individual level,” she said in an interview.

These and other drawbacks have prompted researchers to look for other useful metrics. WHtR, for example, has recently made headway as a potential BMI alternative or complement.
 

 

 

The case for WHtR

Concern about overreliance on BMI despite its limitations is not new. In 2015, an American Heart Association scientific statement from the group’s Obesity Committee concluded that “BMI alone, even with lower thresholds, is a useful but not an ideal tool for identification of obesity or assessment of cardiovascular risk,” especially for people from Asian, Black, Hispanic, and Pacific Islander populations.

The writing panel also recommended that clinicians measure waist circumference annually and use that information along with BMI “to better gauge cardiovascular risk in diverse populations.”

Momentum for moving beyond BMI alone has continued to build following the AHA statement.

In September 2022, the National Institute for Health and Care Excellence, which sets policies for the United Kingdom’s National Health Service, revised its guidancefor assessment and management of people with obesity. The updated guidance recommends that when clinicians assess “adults with BMI below 35 kg/m2, measure and use their WHtR, as well as their BMI, as a practical estimate of central adiposity and use these measurements to help to assess and predict health risks.”

NICE released an extensive literature review with the revision, and based on the evidence, said that “using waist-to-height ratio as well as BMI would help give a practical estimate of central adiposity in adults with BMI under 35 kg/m2. This would in turn help professionals assess and predict health risks.”

However, the review added that, “because people with a BMI over 35 kg/m2 are always likely to have a high WHtR, the committee recognized that it may not be a useful addition for predicting health risks in this group.” The 2022 NICE review also said that it is “important to estimate central adiposity when assessing future health risks, including for people whose BMI is in the healthy-weight category.”

This new emphasis by NICE on measuring and using WHtR as part of obesity assessment “represents an important change in population health policy,” commented Dr. Powell-Wiley. “I expect more professional organizations will endorse use of waist circumference or waist-to-height ratio now that NICE has taken this step,” she predicted.

Waist circumference and WHtR may become standard measures of adiposity in clinical practice over the next 5-10 years.

The recent move by NICE to highlight a complementary role for WHtR “is another acknowledgment that BMI is an imperfect tool for stratifying cardiometabolic risk in a diverse population, especially in people with lower BMIs” because of its variability, commented Jamie Almandoz, MD, medical director of the weight wellness program at UT Southwestern Medical Center, Dallas.
 

WHtR vs. BMI

Another recent step forward for WHtR came with the publication of a post hoc analysis of data collected in the PARADIGM-HF trial, a study that had the primary purpose of comparing two medications for improving outcomes in more than 8,000 patients with heart failure with reduced ejection fraction.

The new analysis showed that “two indices that incorporate waist circumference and height, but not weight, showed a clearer association between greater adiposity and a higher risk of heart failure hospitalization,” compared with BMI.

WHtR was one of the two indices identified as being a better correlate for the adverse effect of excess adiposity compared with BMI.

The authors of the post hoc analysis did not design their analysis to compare WHtR with BMI. Instead, their goal was to better understand what’s known as the “obesity paradox” in people with heart failure with reduced ejection fraction: The recurring observation that, when these patients with heart failure have lower BMIs they fare worse, with higher rates of mortality and adverse cardiovascular outcomes, compared with patients with higher BMIs.

The new analysis showed that this paradox disappeared when WHtR was substituted for BMI as the obesity metric.

This “provides meaningful data about the superiority of WHtR, compared with BMI, for predicting heart failure outcomes,” said Dr. Powell-Wiley, although she cautioned that the analysis was limited by scant data in diverse populations and did not look at other important cardiovascular disease outcomes. While Dr. Powell-Wiley does not think that WHtR needs assessment in a prospective, controlled trial, she called for analysis of pooled prospective studies with more diverse populations to better document the advantages of WHtR over BMI.

The PARADIGM-HF post hoc analysis shows again how flawed BMI is for health assessment and the relative importance of an individualized understanding of a person’s body composition, Dr. Almandoz said in an interview. “As we collect more data, there is increasing awareness of how imperfect BMI is.”
 

 

 

Measuring waist circumference is tricky

Although WHtR looks promising as a substitute for or add-on to BMI, it has its own limitations, particularly the challenge of accurately measuring waist circumference.

Measuring waist circumference “not only takes more time but requires the assessor to be well trained about where to put the tape measure and making sure it’s measured at the same place each time,” even when different people take serial measurements from individual patients, noted Dr. Wee. Determining waist circumference can also be technically difficult when done on larger people, she added, and collectively these challenges make waist circumference “less reproducible from measurement to measurement.”

“It’s relatively clear how to standardize measurement of weight and height, but there is a huge amount of variability when the waist is measured,” agreed Dr. Almandoz. “And waist circumference also differs by ethnicity, race, sex, and body frame. There are significant differences in waist circumference levels that associate with increased health risks” between, for example, White and South Asian people.

Another limitation of waist circumference and WHtR is that they “cannot differentiate between visceral and abdominal subcutaneous adipose tissue, which are vastly different regarding cardiometabolic risk, commented Ian Neeland, MD, director of cardiovascular prevention at the University Hospitals Harrington Heart & Vascular Institute, Cleveland.
 

The imaging option

“Waist-to-height ratio is not the ultimate answer,” Dr. Neeland said in an interview. He instead endorsed “advanced imaging for body fat distribution,” such as CT or MRI scans, as his pick for what should be the standard obesity metric, “given that it is much more specific and actionable for both risk assessment and response to therapy. I expect slow but steady advancements that move away from BMI cutoffs, for example for bariatric surgery, given that BMI is an imprecise and crude tool.”

But although imaging with methods like CT and MRI may provide the best accuracy and precision for tracking the volume of a person’s cardiometabolically dangerous fat, they are also hampered by relatively high cost and, for CT and DXA, the issue of radiation exposure.

“CT, MRI, and DXA scans give more in-depth assessment of body composition, but should we expose people to the radiation and the cost?” Dr. Almandoz wondered.

“Height, weight, and waist circumference cost nothing to obtain,” creating a big relative disadvantage for imaging, said Naveed Sattar, MD, professor of metabolic medicine at the University of Glasgow.

“Data would need to show that imaging gives clinicians substantially more information about future risk” to justify its price, Dr. Sattar emphasized.
 

BMI’s limits mean adding on

Regardless of whichever alternatives to BMI end up getting used most, experts generally agree that BMI alone is looking increasingly inadequate.

“Over the next 5 years, BMI will come to be seen as a screening tool that categorizes people into general risk groups” that also needs “other metrics and variables, such as age, race, ethnicity, family history, blood glucose, and blood pressure to better describe health risk in an individual,” predicted Dr. Bessesen.

The endorsement of WHtR by NICE “will lead to more research into how to incorporate WHtR into routine practice. We need more evidence to translate what NICE said into practice,” said Dr. Sattar. “I don’t think we’ll see a shift away from BMI, but we’ll add alternative measures that are particularly useful in certain patients.”

“Because we live in diverse societies, we need to individualize risk assessment and couple that with technology that makes analysis of body composition more accessible,” agreed Dr. Almandoz. He noted that the UT Southwestern weight wellness program where he practices has, for about the past decade, routinely collected waist circumference and bioelectrical impedance data as well as BMI on all people seen in the practice for obesity concerns. Making these additional measurements on a routine basis also helps strengthen patient engagement.

“We get into trouble when we make rigid health policy and clinical decisions based on BMI alone without looking at the patient holistically,” said Dr. Wee. “Patients are more than arbitrary numbers, and clinicians should make clinical decisions based on the totality of evidence for each individual patient.”

Dr. Bessesen, Dr. Wee, Dr. Powell-Wiley, and Dr. Almandoz reported no relevant financial relationships. Dr. Neeland has reported being a consultant for Merck. Dr. Sattar has reported being a consultant or speaker for Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, and Sanofi.

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

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Child’s health improves by applying new obesity guidelines

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At age 15 years, Maya was referred by her primary care provider to our pediatric obesity center. She weighed 151 kg and had a body mass index (BMI) over 48 kg/m2. One year earlier, she had been diagnosed with hypertension and prediabetes.

A review of her growth charts showed that she had been in the 95th percentile at age 8 years. Her weight had steadily risen, with an exponential increase of 55 lb between 2020 and 2022, during the COVID-19 pandemic. Her primary care provider monitored her from age 8 to 12 years, providing nutrition and physical activity counseling.

In February, the American Academy of Pediatrics released new clinical practice guidelines for managing childhood obesity. These new guidelines reflect our increased understanding of obesity as a complex chronic disease. A better understanding of the pathophysiology has challenged the old-worn concept of lack of will power and personal responsibility as the cause of obesity, which has been the basis for weight-related bias and stigma. The updated guidelines have also been influenced by lifestyle intervention studies, the US Food and Drug Administration approval of new anti-obesity medications, and the 2013 designation of obesity as a disease by the American Medical Association.

We used these updated guidelines in our approach to treating Maya.
 

Starting with the assessment

In the new AAP guidelines, assessing the genetic, environmental, and social-determinant risks for obesity form the basis for evaluation and intervention. Following this approach, we conducted a complete medical evaluation of Maya, including a review of her symptoms and her family history along with a physical examination to assess for comorbidities and other cause of obesity (for example, genetic, hypothyroidism).

We also collected information regarding her diet and behaviors (for example, drinking sweet beverages, fruit and vegetable intake, parent feeding style, portion sizes, emotional eating, hyperphagia), physical activity behaviors (for example, physical education, organized sports), screen time, social drivers of health (for example, food insecurity, neighborhood, school environment), family and household factors (for example, family composition, support, number of caregivers, parenting style) and mental and physical health (autism, attention-deficit/hyperactivity disorder, history of being bullied, developmental and physical disabilities). Because Maya had a BMI of 48, she met the criterion for severe obesity, which is having a BMI at least 120% of the 95th percentile.

The guidelines use BMI as a criterion for screening for obesity because it is inexpensive and easy to obtain in the clinic setting. The Centers for Disease Control and Prevention growth chart uses BMI as well. Recently, there has been controversy about solely using BMI to define obesity, which is a point that the guidelines address by emphasizing evaluation of the whole child along with BMI to make a diagnosis of obesity.

The child’s age and the severity of their obesity drive the evaluation for comorbidities and treatment. In children aged 10 years or older, pediatricians and other primary care providers should evaluate for lipid abnormalities, abnormal glucose metabolism, and abnormal liver function in children and adolescents with obesity (BMI ≥ 95th percentile).

Maya presented with snoring, early-morning headaches, daytime sleepiness, and abdominal pain. A sleep study revealed an apnea-hypopnea index of 15, indicating obstructive sleep apnea, and she was placed on a continuous positive airway pressure machine.

Her laboratory studies showed elevated triglycerides of 169 mg/dL and abnormal ALT (123 IU/L). Potential causes of elevated liver function test results (such as abnormal ceruloplasmin levels or infectious or autoimmune hepatitis) were excluded, and a liver ultrasound with elastography indicated steatohepatitis. Maya was referred to gastroenterology for nonalcoholic fatty liver disease.

Maya experienced depressive symptoms, including difficulty with peer relationships and declining academic performance. Her Patient Health Questionnaire–9 score was 21, with a moderate impact on her daily functioning. Prior attempts at counseling had been sporadic and not helpful. She was diagnosed with intermittent moderate clinical depression, started on a selective serotonin reuptake inhibitor, and resumed counseling with a new therapist.
 

 

 

Considering treatment options

Based on shared decision-making, our team began a more intensive lifestyle behavior treatment as recommended in the updated guidelines. Maya chose to decrease sugar-sweetened beverages as her initial nutrition goal, a change that can lead to a reduction of liver function test results and triglycerides, even in the absence of weight loss.

As emphasized in the guidelines, we stressed the importance of managing obesity and comorbidities concurrently to the family. In addition to lifestyle behavior intervention, once her mental health stabilized, Maya and her mother opted for bariatric surgery. Sleeve gastrectomy was elected because she met the criteria.

If the child already has obesity, the guidelines discourage watchful waiting (that is, the expectation that the child will grow into their weight) as Maya’s primary care provider had done when she was younger. The staged treatment approach where progressively more intensive interventions are adopted (a hallmark of the 2007 guidelines) is no longer recommended. Rather, the primary care provider should offer treatment options guided by age, severity of obesity, and comorbidities.

Maya completed a bariatric preoperative program, extensive mental health evaluation, and tolerated the sleeve gastrectomy well with no complications. At her 6-month postoperative visit, she had lost 99 lb (45 kg) since the surgery, with an 18% decline in BMI. She is taking daily multivitamins as well as calcium and vitamin D. She continues to incorporate healthy eating into her life, with a focus on adequate protein intake and is exercising three to four times per week in the apartment complex gym. She reports better physical and mental health, her school performance has improved, and she still receives regular counseling.

Maya’s story outlines the benefits of early and intensive intervention as recommended by the new AAP guidelines. The shift from some of the earlier recommendations is partly driven by the persistence of childhood obesity into adulthood, especially for older children with serious psychosocial and physical comorbidities. Hopefully by implementing the new guidelines, the physician can provide empathetic, bias-free, and effective care that recognizes the needs and environment of the whole child.

Dr. Salhah is a pediatric endocrinology fellow at Nationwide Children’s Hospital, Columbus, Ohio. Dr. Eneli is director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital. Dr. Salhah reported no conflicts of interest. Dr. Eneli reported receiving research grants and income from the National Institutes of Health, the AAP, and the National Academy of Medicine.

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

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At age 15 years, Maya was referred by her primary care provider to our pediatric obesity center. She weighed 151 kg and had a body mass index (BMI) over 48 kg/m2. One year earlier, she had been diagnosed with hypertension and prediabetes.

A review of her growth charts showed that she had been in the 95th percentile at age 8 years. Her weight had steadily risen, with an exponential increase of 55 lb between 2020 and 2022, during the COVID-19 pandemic. Her primary care provider monitored her from age 8 to 12 years, providing nutrition and physical activity counseling.

In February, the American Academy of Pediatrics released new clinical practice guidelines for managing childhood obesity. These new guidelines reflect our increased understanding of obesity as a complex chronic disease. A better understanding of the pathophysiology has challenged the old-worn concept of lack of will power and personal responsibility as the cause of obesity, which has been the basis for weight-related bias and stigma. The updated guidelines have also been influenced by lifestyle intervention studies, the US Food and Drug Administration approval of new anti-obesity medications, and the 2013 designation of obesity as a disease by the American Medical Association.

We used these updated guidelines in our approach to treating Maya.
 

Starting with the assessment

In the new AAP guidelines, assessing the genetic, environmental, and social-determinant risks for obesity form the basis for evaluation and intervention. Following this approach, we conducted a complete medical evaluation of Maya, including a review of her symptoms and her family history along with a physical examination to assess for comorbidities and other cause of obesity (for example, genetic, hypothyroidism).

We also collected information regarding her diet and behaviors (for example, drinking sweet beverages, fruit and vegetable intake, parent feeding style, portion sizes, emotional eating, hyperphagia), physical activity behaviors (for example, physical education, organized sports), screen time, social drivers of health (for example, food insecurity, neighborhood, school environment), family and household factors (for example, family composition, support, number of caregivers, parenting style) and mental and physical health (autism, attention-deficit/hyperactivity disorder, history of being bullied, developmental and physical disabilities). Because Maya had a BMI of 48, she met the criterion for severe obesity, which is having a BMI at least 120% of the 95th percentile.

The guidelines use BMI as a criterion for screening for obesity because it is inexpensive and easy to obtain in the clinic setting. The Centers for Disease Control and Prevention growth chart uses BMI as well. Recently, there has been controversy about solely using BMI to define obesity, which is a point that the guidelines address by emphasizing evaluation of the whole child along with BMI to make a diagnosis of obesity.

The child’s age and the severity of their obesity drive the evaluation for comorbidities and treatment. In children aged 10 years or older, pediatricians and other primary care providers should evaluate for lipid abnormalities, abnormal glucose metabolism, and abnormal liver function in children and adolescents with obesity (BMI ≥ 95th percentile).

Maya presented with snoring, early-morning headaches, daytime sleepiness, and abdominal pain. A sleep study revealed an apnea-hypopnea index of 15, indicating obstructive sleep apnea, and she was placed on a continuous positive airway pressure machine.

Her laboratory studies showed elevated triglycerides of 169 mg/dL and abnormal ALT (123 IU/L). Potential causes of elevated liver function test results (such as abnormal ceruloplasmin levels or infectious or autoimmune hepatitis) were excluded, and a liver ultrasound with elastography indicated steatohepatitis. Maya was referred to gastroenterology for nonalcoholic fatty liver disease.

Maya experienced depressive symptoms, including difficulty with peer relationships and declining academic performance. Her Patient Health Questionnaire–9 score was 21, with a moderate impact on her daily functioning. Prior attempts at counseling had been sporadic and not helpful. She was diagnosed with intermittent moderate clinical depression, started on a selective serotonin reuptake inhibitor, and resumed counseling with a new therapist.
 

 

 

Considering treatment options

Based on shared decision-making, our team began a more intensive lifestyle behavior treatment as recommended in the updated guidelines. Maya chose to decrease sugar-sweetened beverages as her initial nutrition goal, a change that can lead to a reduction of liver function test results and triglycerides, even in the absence of weight loss.

As emphasized in the guidelines, we stressed the importance of managing obesity and comorbidities concurrently to the family. In addition to lifestyle behavior intervention, once her mental health stabilized, Maya and her mother opted for bariatric surgery. Sleeve gastrectomy was elected because she met the criteria.

If the child already has obesity, the guidelines discourage watchful waiting (that is, the expectation that the child will grow into their weight) as Maya’s primary care provider had done when she was younger. The staged treatment approach where progressively more intensive interventions are adopted (a hallmark of the 2007 guidelines) is no longer recommended. Rather, the primary care provider should offer treatment options guided by age, severity of obesity, and comorbidities.

Maya completed a bariatric preoperative program, extensive mental health evaluation, and tolerated the sleeve gastrectomy well with no complications. At her 6-month postoperative visit, she had lost 99 lb (45 kg) since the surgery, with an 18% decline in BMI. She is taking daily multivitamins as well as calcium and vitamin D. She continues to incorporate healthy eating into her life, with a focus on adequate protein intake and is exercising three to four times per week in the apartment complex gym. She reports better physical and mental health, her school performance has improved, and she still receives regular counseling.

Maya’s story outlines the benefits of early and intensive intervention as recommended by the new AAP guidelines. The shift from some of the earlier recommendations is partly driven by the persistence of childhood obesity into adulthood, especially for older children with serious psychosocial and physical comorbidities. Hopefully by implementing the new guidelines, the physician can provide empathetic, bias-free, and effective care that recognizes the needs and environment of the whole child.

Dr. Salhah is a pediatric endocrinology fellow at Nationwide Children’s Hospital, Columbus, Ohio. Dr. Eneli is director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital. Dr. Salhah reported no conflicts of interest. Dr. Eneli reported receiving research grants and income from the National Institutes of Health, the AAP, and the National Academy of Medicine.

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

At age 15 years, Maya was referred by her primary care provider to our pediatric obesity center. She weighed 151 kg and had a body mass index (BMI) over 48 kg/m2. One year earlier, she had been diagnosed with hypertension and prediabetes.

A review of her growth charts showed that she had been in the 95th percentile at age 8 years. Her weight had steadily risen, with an exponential increase of 55 lb between 2020 and 2022, during the COVID-19 pandemic. Her primary care provider monitored her from age 8 to 12 years, providing nutrition and physical activity counseling.

In February, the American Academy of Pediatrics released new clinical practice guidelines for managing childhood obesity. These new guidelines reflect our increased understanding of obesity as a complex chronic disease. A better understanding of the pathophysiology has challenged the old-worn concept of lack of will power and personal responsibility as the cause of obesity, which has been the basis for weight-related bias and stigma. The updated guidelines have also been influenced by lifestyle intervention studies, the US Food and Drug Administration approval of new anti-obesity medications, and the 2013 designation of obesity as a disease by the American Medical Association.

We used these updated guidelines in our approach to treating Maya.
 

Starting with the assessment

In the new AAP guidelines, assessing the genetic, environmental, and social-determinant risks for obesity form the basis for evaluation and intervention. Following this approach, we conducted a complete medical evaluation of Maya, including a review of her symptoms and her family history along with a physical examination to assess for comorbidities and other cause of obesity (for example, genetic, hypothyroidism).

We also collected information regarding her diet and behaviors (for example, drinking sweet beverages, fruit and vegetable intake, parent feeding style, portion sizes, emotional eating, hyperphagia), physical activity behaviors (for example, physical education, organized sports), screen time, social drivers of health (for example, food insecurity, neighborhood, school environment), family and household factors (for example, family composition, support, number of caregivers, parenting style) and mental and physical health (autism, attention-deficit/hyperactivity disorder, history of being bullied, developmental and physical disabilities). Because Maya had a BMI of 48, she met the criterion for severe obesity, which is having a BMI at least 120% of the 95th percentile.

The guidelines use BMI as a criterion for screening for obesity because it is inexpensive and easy to obtain in the clinic setting. The Centers for Disease Control and Prevention growth chart uses BMI as well. Recently, there has been controversy about solely using BMI to define obesity, which is a point that the guidelines address by emphasizing evaluation of the whole child along with BMI to make a diagnosis of obesity.

The child’s age and the severity of their obesity drive the evaluation for comorbidities and treatment. In children aged 10 years or older, pediatricians and other primary care providers should evaluate for lipid abnormalities, abnormal glucose metabolism, and abnormal liver function in children and adolescents with obesity (BMI ≥ 95th percentile).

Maya presented with snoring, early-morning headaches, daytime sleepiness, and abdominal pain. A sleep study revealed an apnea-hypopnea index of 15, indicating obstructive sleep apnea, and she was placed on a continuous positive airway pressure machine.

Her laboratory studies showed elevated triglycerides of 169 mg/dL and abnormal ALT (123 IU/L). Potential causes of elevated liver function test results (such as abnormal ceruloplasmin levels or infectious or autoimmune hepatitis) were excluded, and a liver ultrasound with elastography indicated steatohepatitis. Maya was referred to gastroenterology for nonalcoholic fatty liver disease.

Maya experienced depressive symptoms, including difficulty with peer relationships and declining academic performance. Her Patient Health Questionnaire–9 score was 21, with a moderate impact on her daily functioning. Prior attempts at counseling had been sporadic and not helpful. She was diagnosed with intermittent moderate clinical depression, started on a selective serotonin reuptake inhibitor, and resumed counseling with a new therapist.
 

 

 

Considering treatment options

Based on shared decision-making, our team began a more intensive lifestyle behavior treatment as recommended in the updated guidelines. Maya chose to decrease sugar-sweetened beverages as her initial nutrition goal, a change that can lead to a reduction of liver function test results and triglycerides, even in the absence of weight loss.

As emphasized in the guidelines, we stressed the importance of managing obesity and comorbidities concurrently to the family. In addition to lifestyle behavior intervention, once her mental health stabilized, Maya and her mother opted for bariatric surgery. Sleeve gastrectomy was elected because she met the criteria.

If the child already has obesity, the guidelines discourage watchful waiting (that is, the expectation that the child will grow into their weight) as Maya’s primary care provider had done when she was younger. The staged treatment approach where progressively more intensive interventions are adopted (a hallmark of the 2007 guidelines) is no longer recommended. Rather, the primary care provider should offer treatment options guided by age, severity of obesity, and comorbidities.

Maya completed a bariatric preoperative program, extensive mental health evaluation, and tolerated the sleeve gastrectomy well with no complications. At her 6-month postoperative visit, she had lost 99 lb (45 kg) since the surgery, with an 18% decline in BMI. She is taking daily multivitamins as well as calcium and vitamin D. She continues to incorporate healthy eating into her life, with a focus on adequate protein intake and is exercising three to four times per week in the apartment complex gym. She reports better physical and mental health, her school performance has improved, and she still receives regular counseling.

Maya’s story outlines the benefits of early and intensive intervention as recommended by the new AAP guidelines. The shift from some of the earlier recommendations is partly driven by the persistence of childhood obesity into adulthood, especially for older children with serious psychosocial and physical comorbidities. Hopefully by implementing the new guidelines, the physician can provide empathetic, bias-free, and effective care that recognizes the needs and environment of the whole child.

Dr. Salhah is a pediatric endocrinology fellow at Nationwide Children’s Hospital, Columbus, Ohio. Dr. Eneli is director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital. Dr. Salhah reported no conflicts of interest. Dr. Eneli reported receiving research grants and income from the National Institutes of Health, the AAP, and the National Academy of Medicine.

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

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Weight gain and excessive fatigue

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This patient's clinical presentation and laboratory findings are consistent with a diagnosis of Cushing syndrome (CS).

CS is a rare endocrine disease caused by prolonged exposure to high circulating cortisol levels. Exogenous hypercortisolism is the most common cause of CS. It is largely iatrogenic and results from the prolonged use of glucocorticoids. Less frequently, endogenous CS may occur as the result of excessive production of cortisol by adrenal glands. Endogenous CS can be ACTH-dependent or ACTH-independent. ACTH-dependent CS results from ACTH-secreting pituitary adenomas (Cushing disease) and ectopic ACTH secretion by neoplasms, whereas adrenal hyperplasia, adenoma, and carcinoma are the primary causes of ACTH-independent CS.

The annual incidence and prevalence of CS are unknown; the reported incidence of newly diagnosed cases has ranged from 1.2 to 2.4 per million people per year. Women are affected more often than are men, with a peak of incidence in the third to fourth decade of life. CS is associated with various metabolic, psychiatric, musculoskeletal, and cardiovascular comorbidities. Untreated, it is associated with increased mortality, typically as the result of cardiovascular and infectious complications; however, even in appropriately treated patients, mortality is elevated.

The chronic elevations of glucocorticoid concentrations in CS result in its characteristic phenotype, which includes weight gain, moon-shaped face, buffalo hump, muscle weakness, increased bruising, skin atrophy, red abdominal striae, menstrual irregularities, hirsutism, and acne. It is also associated with numerous comorbidities including diabetes, hypertension, hypercholesterolemia, and osteoporosis. Patients often experience mental health complications, such as depression, emotional lability, and cognitive dysfunction.

Given the rarity of CS and the fact that these symptoms overlap with other conditions, delayed diagnosis is common. The current obesity epidemic also poses diagnostic challenges because true CS can be difficult to differentiate from metabolic syndrome. The duration of hypercortisolism appears to be the most significant factor associated with the degree of morbidity and preterm mortality in CS; thus, an accurate diagnosis as early as possible is important.

Screening and diagnostic tests for CS evaluate cortisol secretion. Available options include late-night salivary cortisol (LNSC), impaired glucocorticoid feedback with overnight 1-mg DST or low-dose 2-day dexamethasone test (LDDT) and increased bioavailable cortisol with 24-hour UFC.

A 2021 consensus statement by Fleseriu and colleagues provides recommendations for the diagnosis of CS. If CS is suspected: begin with UFC, LNSC, or both; DST is an option if LNSC not feasible. If CS because of adrenal tumor is suspected: begin with DST because LNSC has lower specificity in these patients. To confirm CS, any of these tests can be used.

An individualized approach is recommended for the treatment of CS. The optimal approach for iatrogenic CS is to slowly taper exogenous steroids. Chronic exposure to steroids can suppress adrenal functioning; as such, recovery may take several months. Surgical resection is the first-line option for hypercortisolism because of Cushing disease, adrenal tumor, or ectopic tumor. Patients should be closely monitored after surgery to evaluate for possible recurrence. Radiotherapy may be recommended after failed transsphenoidal surgery or in Cushing disease with mass effect or invasion of surrounding structures. Medical therapy, such as pasireotide, cabergoline, and mifepristone, are also sometimes used. In addition, the treatment of comorbidities, such as obesity and type 2 diabetes, hypertension, osteoporosis, psychiatric issues, and electrolyte disorders, is critical.

 

Courtney Whittle, MD, MSW, Diplomate of ABOM, Pediatric Lead, Obesity Champion, TSPMG, Weight A Minute Clinic, Atlanta, Georgia.

Courtney Whittle, MD, MSW, Diplomate of ABOM, has disclosed no relevant financial relationships.

 

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

 

 

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This patient's clinical presentation and laboratory findings are consistent with a diagnosis of Cushing syndrome (CS).

CS is a rare endocrine disease caused by prolonged exposure to high circulating cortisol levels. Exogenous hypercortisolism is the most common cause of CS. It is largely iatrogenic and results from the prolonged use of glucocorticoids. Less frequently, endogenous CS may occur as the result of excessive production of cortisol by adrenal glands. Endogenous CS can be ACTH-dependent or ACTH-independent. ACTH-dependent CS results from ACTH-secreting pituitary adenomas (Cushing disease) and ectopic ACTH secretion by neoplasms, whereas adrenal hyperplasia, adenoma, and carcinoma are the primary causes of ACTH-independent CS.

The annual incidence and prevalence of CS are unknown; the reported incidence of newly diagnosed cases has ranged from 1.2 to 2.4 per million people per year. Women are affected more often than are men, with a peak of incidence in the third to fourth decade of life. CS is associated with various metabolic, psychiatric, musculoskeletal, and cardiovascular comorbidities. Untreated, it is associated with increased mortality, typically as the result of cardiovascular and infectious complications; however, even in appropriately treated patients, mortality is elevated.

The chronic elevations of glucocorticoid concentrations in CS result in its characteristic phenotype, which includes weight gain, moon-shaped face, buffalo hump, muscle weakness, increased bruising, skin atrophy, red abdominal striae, menstrual irregularities, hirsutism, and acne. It is also associated with numerous comorbidities including diabetes, hypertension, hypercholesterolemia, and osteoporosis. Patients often experience mental health complications, such as depression, emotional lability, and cognitive dysfunction.

Given the rarity of CS and the fact that these symptoms overlap with other conditions, delayed diagnosis is common. The current obesity epidemic also poses diagnostic challenges because true CS can be difficult to differentiate from metabolic syndrome. The duration of hypercortisolism appears to be the most significant factor associated with the degree of morbidity and preterm mortality in CS; thus, an accurate diagnosis as early as possible is important.

Screening and diagnostic tests for CS evaluate cortisol secretion. Available options include late-night salivary cortisol (LNSC), impaired glucocorticoid feedback with overnight 1-mg DST or low-dose 2-day dexamethasone test (LDDT) and increased bioavailable cortisol with 24-hour UFC.

A 2021 consensus statement by Fleseriu and colleagues provides recommendations for the diagnosis of CS. If CS is suspected: begin with UFC, LNSC, or both; DST is an option if LNSC not feasible. If CS because of adrenal tumor is suspected: begin with DST because LNSC has lower specificity in these patients. To confirm CS, any of these tests can be used.

An individualized approach is recommended for the treatment of CS. The optimal approach for iatrogenic CS is to slowly taper exogenous steroids. Chronic exposure to steroids can suppress adrenal functioning; as such, recovery may take several months. Surgical resection is the first-line option for hypercortisolism because of Cushing disease, adrenal tumor, or ectopic tumor. Patients should be closely monitored after surgery to evaluate for possible recurrence. Radiotherapy may be recommended after failed transsphenoidal surgery or in Cushing disease with mass effect or invasion of surrounding structures. Medical therapy, such as pasireotide, cabergoline, and mifepristone, are also sometimes used. In addition, the treatment of comorbidities, such as obesity and type 2 diabetes, hypertension, osteoporosis, psychiatric issues, and electrolyte disorders, is critical.

 

Courtney Whittle, MD, MSW, Diplomate of ABOM, Pediatric Lead, Obesity Champion, TSPMG, Weight A Minute Clinic, Atlanta, Georgia.

Courtney Whittle, MD, MSW, Diplomate of ABOM, has disclosed no relevant financial relationships.

 

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

 

 

This patient's clinical presentation and laboratory findings are consistent with a diagnosis of Cushing syndrome (CS).

CS is a rare endocrine disease caused by prolonged exposure to high circulating cortisol levels. Exogenous hypercortisolism is the most common cause of CS. It is largely iatrogenic and results from the prolonged use of glucocorticoids. Less frequently, endogenous CS may occur as the result of excessive production of cortisol by adrenal glands. Endogenous CS can be ACTH-dependent or ACTH-independent. ACTH-dependent CS results from ACTH-secreting pituitary adenomas (Cushing disease) and ectopic ACTH secretion by neoplasms, whereas adrenal hyperplasia, adenoma, and carcinoma are the primary causes of ACTH-independent CS.

The annual incidence and prevalence of CS are unknown; the reported incidence of newly diagnosed cases has ranged from 1.2 to 2.4 per million people per year. Women are affected more often than are men, with a peak of incidence in the third to fourth decade of life. CS is associated with various metabolic, psychiatric, musculoskeletal, and cardiovascular comorbidities. Untreated, it is associated with increased mortality, typically as the result of cardiovascular and infectious complications; however, even in appropriately treated patients, mortality is elevated.

The chronic elevations of glucocorticoid concentrations in CS result in its characteristic phenotype, which includes weight gain, moon-shaped face, buffalo hump, muscle weakness, increased bruising, skin atrophy, red abdominal striae, menstrual irregularities, hirsutism, and acne. It is also associated with numerous comorbidities including diabetes, hypertension, hypercholesterolemia, and osteoporosis. Patients often experience mental health complications, such as depression, emotional lability, and cognitive dysfunction.

Given the rarity of CS and the fact that these symptoms overlap with other conditions, delayed diagnosis is common. The current obesity epidemic also poses diagnostic challenges because true CS can be difficult to differentiate from metabolic syndrome. The duration of hypercortisolism appears to be the most significant factor associated with the degree of morbidity and preterm mortality in CS; thus, an accurate diagnosis as early as possible is important.

Screening and diagnostic tests for CS evaluate cortisol secretion. Available options include late-night salivary cortisol (LNSC), impaired glucocorticoid feedback with overnight 1-mg DST or low-dose 2-day dexamethasone test (LDDT) and increased bioavailable cortisol with 24-hour UFC.

A 2021 consensus statement by Fleseriu and colleagues provides recommendations for the diagnosis of CS. If CS is suspected: begin with UFC, LNSC, or both; DST is an option if LNSC not feasible. If CS because of adrenal tumor is suspected: begin with DST because LNSC has lower specificity in these patients. To confirm CS, any of these tests can be used.

An individualized approach is recommended for the treatment of CS. The optimal approach for iatrogenic CS is to slowly taper exogenous steroids. Chronic exposure to steroids can suppress adrenal functioning; as such, recovery may take several months. Surgical resection is the first-line option for hypercortisolism because of Cushing disease, adrenal tumor, or ectopic tumor. Patients should be closely monitored after surgery to evaluate for possible recurrence. Radiotherapy may be recommended after failed transsphenoidal surgery or in Cushing disease with mass effect or invasion of surrounding structures. Medical therapy, such as pasireotide, cabergoline, and mifepristone, are also sometimes used. In addition, the treatment of comorbidities, such as obesity and type 2 diabetes, hypertension, osteoporosis, psychiatric issues, and electrolyte disorders, is critical.

 

Courtney Whittle, MD, MSW, Diplomate of ABOM, Pediatric Lead, Obesity Champion, TSPMG, Weight A Minute Clinic, Atlanta, Georgia.

Courtney Whittle, MD, MSW, Diplomate of ABOM, has disclosed no relevant financial relationships.

 

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

 

 

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A 37-year-old woman presents with reports of insomnia, weight gain (approximately 12 lb over the last 9 months), and excessive fatigue. The patient's medical history is significant for hypertension (diagnosed 4 years earlier) and depression (diagnosed 7 years earlier). Her current medications include lisinopril 10 mg/d, bupropion 75 mg/d, and venlafaxine 75 mg/d. There is no history of alcohol or drug abuse; family history is unremarkable. The patient's height and weight are 5 ft 5 in and 182 lb (body mass index of 30.3). 

During physical examination, facial hirsutism is observed along with increased adipose tissue in the face (moon-shaped face), upper back at the base of the neck (buffalo hump), and abdomen. Vertical red abdominal striae are present. Several bruises are observed on the patient's thighs and arms; when questioned, she reports noting an increased tendency to bruise in recent months. 

Pertinent laboratory findings include urinary free cortisol excretion (UFC) 324 mcg/24 h, 1-mg dexamethasone suppression test (DST) with a cortisol value of 3.64 mcg/dL (100.42 nmol/L), and adrenocorticotropic hormone (ACTH) level of 84.9 pg/mL.

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Optimal time period for weight loss drugs: Debate continues

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After bariatric surgery in 2014, Kristal Hartman still struggled to manage her weight long term. It took her over a year to lose 100 pounds, a loss she initially maintained, but then gradually her body mass index (BMI) started creeping up again.

“The body kind of has a set point, and you have to constantly trick it because it is going to start to gain weight again,” Ms. Hartman, who is on the national board of directors for the Obesity Action Coalition, said in an interview.

So, 2.5 years after her surgery, Ms. Hartman began weekly subcutaneous injections of the glucagonlike peptide–1 (GLP-1) agonist semaglutide, a medication that is now almost infamous because of its popularity among celebrities and social media influencers.

Branded as Ozempic for type 2 diabetes and Wegovy for obesity, both contain semaglutide but in slightly different doses. The popularity of the medication has led to shortages for those living with type 2 diabetes and/or obesity. And other medications are waiting in the wings that work on GLP-1 and other hormones that regulate appetite, such as the twincretin tirzepatide (Mounjaro), another weekly injection, approved by the Food and Drug Administration in May 2022 for type 2 diabetes and awaiting approval for obesity.

Ms. Hartman said taking semaglutide helped her not only lose weight but also “curb [her] obsessive thoughts over food.” To maintain a BMI within the healthy range, as well as taking the GLP-1 agonist, Ms. Hartman relies on other strategies, including exercise, and mental health support.

“Physicians really need to be open to these FDA-approved medications as one of many tools in the toolbox for patients with obesity. It’s just like any other chronic disease state, when they are thinking of using these, they need to think about long-term use ... in patients who have obesity, not just [among those people] who just want to lose 5-10 pounds. That’s not what these drugs are designed for. They are for people who are actually living with the chronic disease of obesity every day of their lives,” she emphasized.

On average, patients lose 25%-40% of their total body weight following bariatric surgery, said Teresa LeMasters, MD, president of the American Society for Metabolic & Bariatric Surgery. However, there typically is a “small” weight regain after surgery.

“For most patients, it is a small 5-10 pounds, but for some others, it can be significant,” said Dr. LeMasters, a bariatric surgeon at UnityPoint Clinic, Des Moines, Iowa.

“We do still see some patients– anywhere from 10% to 30% – who will have some [significant] weight regain, and so then we will look at that,” she noted. In those cases, the disease of obesity “is definitely still present.”
 

Medications can counter weight regain after surgery

For patients who don’t reach their weight loss goals after bariatric surgery, Dr. LeMasters said it’s appropriate to consider adding an anti-obesity medication. The newer GLP-1 agonists can lead to a loss of around 15% of body weight in some patients.

“The GLP-1 agonists have been very helpful for treating patients who’ve had bariatric surgery and had some weight regain, or even just to optimize their initial response to surgery if they are starting at a very, very severe point of disease,” she explained.

She noted, however, that some patients shouldn’t be prescribed GLP-1 agonists, including those with a history of thyroid cancer or pancreatitis.

Caroline M. Apovian, MD, codirector of the center for weight management and wellness and professor of medicine at Harvard Medical School, Boston, said in an interview that the physiology behind bariatric surgery and that of the newer obesity medications is somewhat aligned.

“In order to reduce ... body weight permanently you need adjustments. We learned that you need the adjustments of the hormones [that affect appetite, such as GLP-1], and that’s why bariatric surgery works because ... [it] provides the most durable and the most effective treatment for obesity ... because [with surgery] you are adjusting the secretion and timing of many of the hormones that regulate body weight,” she explained.

So, when people are taking GLP-1 agonists for obesity, with or without surgery, these medications “are meant and were approved by the FDA to be taken indefinitely. They are not [for the] short term,” Dr. Apovian noted.

Benjamin O’Donnell, MD, an associate professor at Ohio State University Wexner Medical Center, Columbus, agreed that the newer anti-obesity medications can be very effective; however, he expressed uncertainty about prescribing these medications for years and years.

“If somebody has obesity, they need medicine to help them manage appetite and maintain a lower, healthier weight. It would make sense that they would just stay on the medicine,” he noted.

But he qualified: “I have a hard time committing to saying that someone should take this medication for the rest of their life. Part of my hesitation is that the medications are expensive, so we’ve had a hard time with people staying on them, mostly because of insurance formulary changes.”
 

 

 

Why stop the medications? Side effects and lack of insurance coverage

Many people have to discontinue these newer medications for that exact reason.

When Ms. Hartman’s insurance coverage lapsed, she had to go without semaglutide for a while.

“At that time, I absolutely gained weight back up into an abnormal BMI range,” Ms. Hartman said. When she was able to resume the medication, she lost weight again and her BMI returned to normal range.

These medications currently cost around $1,400 per month in the United States, unless patients can access initiatives such as company coupons. Some insurers, including state-subsidized Medicare and Medicaid, don’t cover the new medications.

Dr. O’Donnell said, “More accessibility for more people would help in the big picture.”

Other patients stop taking GLP-1 agonists because they experience side effects, such as nausea.

“Gastrointestinal complaints ... are the number one reason for people to come off the medication,” said Disha Narang, MD, an endocrinologist and obesity medicine specialist at Northwestern Medicine Lake Forest (Ill.) Hospital.

“It is an elective therapy, so it is not mandatory that someone take it. So if they are not feeling well or they are sick, then that’s a major reason for coming off of it,” she said.

Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, and chief of endocrinology, agreed.

Patients are unlikely to stay on these medications if they feel nauseous or experience vomiting, he said. Although he noted there are options to try to counter this, such as starting patients on a very low dose of the drug and up-titrating slowly. This method requires good coordination between the patient and physician.

Goutham Rao, MD, a professor of medicine at Case Western Reserve University and head of the weight-loss initiative Fitter Me at University Hospitals, both in Cleveland, said that prior to prescribing GLP-1 agonists for weight loss, he sets four basic, nonnegotiable goals for patients: “to have breakfast within 30 minutes of getting up, to drink just water, no food or drink after 7:00 p.m. except for water, and 30 minutes of continuous exercise per day, which is typically, for older clientele, walking.”

This, he said, can help establish good habits because if “patients are not engaged psychologically in weight loss ... they expect the medication to do [all] the work.”
 

Most regain weight after stopping obesity medications

As Ms. Hartman’s story illustrates, discontinuing the medications often leads to weight regain.

“Without the medicine, there are a variety of things that will happen. Appetite will tend to increase, and so [patients] will gradually tend to eat more over time,” Dr. Bessesen noted.

“So it may take a long time for the weight regain to happen, but in every study where an obesity medicine has been used, and then it is stopped, the weight goes back to where it was on lifestyle alone,” he added.

In the STEP 1 trial, almost 2,000 patients who were either overweight or living with obesity were randomized 2:1 to semaglutide, titrated up to 2.4 mg each week by week 16, or placebo in addition to lifestyle modification. After 68 weeks, those in the semaglutide group had a mean weight loss of 14.9%, compared with 2.4% in the placebo group.

Patients were also followed in a 1-year extension of the trial, published in Diabetes, Obesity, and Metabolism.

Within 1 year of stopping treatment, participants regained two thirds of the weight they had initially lost.

Hence, Dr. Bessesen stressed that a total rethink of how obesity is approached is needed among most physicians.

“I think in the future treating obesity with medications should be like treating hypertension and diabetes, something most primary care doctors are comfortable doing, but that’s going to take a little work and practice on the part of clinicians to really have a comfortable conversation about risks, and benefits, with patients,” he said.

“I would encourage primary care doctors to learn more about the treatment of obesity, and learn more about bias and stigma, and think about how they can deliver care that is compassionate and competent,” he concluded.

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

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After bariatric surgery in 2014, Kristal Hartman still struggled to manage her weight long term. It took her over a year to lose 100 pounds, a loss she initially maintained, but then gradually her body mass index (BMI) started creeping up again.

“The body kind of has a set point, and you have to constantly trick it because it is going to start to gain weight again,” Ms. Hartman, who is on the national board of directors for the Obesity Action Coalition, said in an interview.

So, 2.5 years after her surgery, Ms. Hartman began weekly subcutaneous injections of the glucagonlike peptide–1 (GLP-1) agonist semaglutide, a medication that is now almost infamous because of its popularity among celebrities and social media influencers.

Branded as Ozempic for type 2 diabetes and Wegovy for obesity, both contain semaglutide but in slightly different doses. The popularity of the medication has led to shortages for those living with type 2 diabetes and/or obesity. And other medications are waiting in the wings that work on GLP-1 and other hormones that regulate appetite, such as the twincretin tirzepatide (Mounjaro), another weekly injection, approved by the Food and Drug Administration in May 2022 for type 2 diabetes and awaiting approval for obesity.

Ms. Hartman said taking semaglutide helped her not only lose weight but also “curb [her] obsessive thoughts over food.” To maintain a BMI within the healthy range, as well as taking the GLP-1 agonist, Ms. Hartman relies on other strategies, including exercise, and mental health support.

“Physicians really need to be open to these FDA-approved medications as one of many tools in the toolbox for patients with obesity. It’s just like any other chronic disease state, when they are thinking of using these, they need to think about long-term use ... in patients who have obesity, not just [among those people] who just want to lose 5-10 pounds. That’s not what these drugs are designed for. They are for people who are actually living with the chronic disease of obesity every day of their lives,” she emphasized.

On average, patients lose 25%-40% of their total body weight following bariatric surgery, said Teresa LeMasters, MD, president of the American Society for Metabolic & Bariatric Surgery. However, there typically is a “small” weight regain after surgery.

“For most patients, it is a small 5-10 pounds, but for some others, it can be significant,” said Dr. LeMasters, a bariatric surgeon at UnityPoint Clinic, Des Moines, Iowa.

“We do still see some patients– anywhere from 10% to 30% – who will have some [significant] weight regain, and so then we will look at that,” she noted. In those cases, the disease of obesity “is definitely still present.”
 

Medications can counter weight regain after surgery

For patients who don’t reach their weight loss goals after bariatric surgery, Dr. LeMasters said it’s appropriate to consider adding an anti-obesity medication. The newer GLP-1 agonists can lead to a loss of around 15% of body weight in some patients.

“The GLP-1 agonists have been very helpful for treating patients who’ve had bariatric surgery and had some weight regain, or even just to optimize their initial response to surgery if they are starting at a very, very severe point of disease,” she explained.

She noted, however, that some patients shouldn’t be prescribed GLP-1 agonists, including those with a history of thyroid cancer or pancreatitis.

Caroline M. Apovian, MD, codirector of the center for weight management and wellness and professor of medicine at Harvard Medical School, Boston, said in an interview that the physiology behind bariatric surgery and that of the newer obesity medications is somewhat aligned.

“In order to reduce ... body weight permanently you need adjustments. We learned that you need the adjustments of the hormones [that affect appetite, such as GLP-1], and that’s why bariatric surgery works because ... [it] provides the most durable and the most effective treatment for obesity ... because [with surgery] you are adjusting the secretion and timing of many of the hormones that regulate body weight,” she explained.

So, when people are taking GLP-1 agonists for obesity, with or without surgery, these medications “are meant and were approved by the FDA to be taken indefinitely. They are not [for the] short term,” Dr. Apovian noted.

Benjamin O’Donnell, MD, an associate professor at Ohio State University Wexner Medical Center, Columbus, agreed that the newer anti-obesity medications can be very effective; however, he expressed uncertainty about prescribing these medications for years and years.

“If somebody has obesity, they need medicine to help them manage appetite and maintain a lower, healthier weight. It would make sense that they would just stay on the medicine,” he noted.

But he qualified: “I have a hard time committing to saying that someone should take this medication for the rest of their life. Part of my hesitation is that the medications are expensive, so we’ve had a hard time with people staying on them, mostly because of insurance formulary changes.”
 

 

 

Why stop the medications? Side effects and lack of insurance coverage

Many people have to discontinue these newer medications for that exact reason.

When Ms. Hartman’s insurance coverage lapsed, she had to go without semaglutide for a while.

“At that time, I absolutely gained weight back up into an abnormal BMI range,” Ms. Hartman said. When she was able to resume the medication, she lost weight again and her BMI returned to normal range.

These medications currently cost around $1,400 per month in the United States, unless patients can access initiatives such as company coupons. Some insurers, including state-subsidized Medicare and Medicaid, don’t cover the new medications.

Dr. O’Donnell said, “More accessibility for more people would help in the big picture.”

Other patients stop taking GLP-1 agonists because they experience side effects, such as nausea.

“Gastrointestinal complaints ... are the number one reason for people to come off the medication,” said Disha Narang, MD, an endocrinologist and obesity medicine specialist at Northwestern Medicine Lake Forest (Ill.) Hospital.

“It is an elective therapy, so it is not mandatory that someone take it. So if they are not feeling well or they are sick, then that’s a major reason for coming off of it,” she said.

Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, and chief of endocrinology, agreed.

Patients are unlikely to stay on these medications if they feel nauseous or experience vomiting, he said. Although he noted there are options to try to counter this, such as starting patients on a very low dose of the drug and up-titrating slowly. This method requires good coordination between the patient and physician.

Goutham Rao, MD, a professor of medicine at Case Western Reserve University and head of the weight-loss initiative Fitter Me at University Hospitals, both in Cleveland, said that prior to prescribing GLP-1 agonists for weight loss, he sets four basic, nonnegotiable goals for patients: “to have breakfast within 30 minutes of getting up, to drink just water, no food or drink after 7:00 p.m. except for water, and 30 minutes of continuous exercise per day, which is typically, for older clientele, walking.”

This, he said, can help establish good habits because if “patients are not engaged psychologically in weight loss ... they expect the medication to do [all] the work.”
 

Most regain weight after stopping obesity medications

As Ms. Hartman’s story illustrates, discontinuing the medications often leads to weight regain.

“Without the medicine, there are a variety of things that will happen. Appetite will tend to increase, and so [patients] will gradually tend to eat more over time,” Dr. Bessesen noted.

“So it may take a long time for the weight regain to happen, but in every study where an obesity medicine has been used, and then it is stopped, the weight goes back to where it was on lifestyle alone,” he added.

In the STEP 1 trial, almost 2,000 patients who were either overweight or living with obesity were randomized 2:1 to semaglutide, titrated up to 2.4 mg each week by week 16, or placebo in addition to lifestyle modification. After 68 weeks, those in the semaglutide group had a mean weight loss of 14.9%, compared with 2.4% in the placebo group.

Patients were also followed in a 1-year extension of the trial, published in Diabetes, Obesity, and Metabolism.

Within 1 year of stopping treatment, participants regained two thirds of the weight they had initially lost.

Hence, Dr. Bessesen stressed that a total rethink of how obesity is approached is needed among most physicians.

“I think in the future treating obesity with medications should be like treating hypertension and diabetes, something most primary care doctors are comfortable doing, but that’s going to take a little work and practice on the part of clinicians to really have a comfortable conversation about risks, and benefits, with patients,” he said.

“I would encourage primary care doctors to learn more about the treatment of obesity, and learn more about bias and stigma, and think about how they can deliver care that is compassionate and competent,” he concluded.

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

After bariatric surgery in 2014, Kristal Hartman still struggled to manage her weight long term. It took her over a year to lose 100 pounds, a loss she initially maintained, but then gradually her body mass index (BMI) started creeping up again.

“The body kind of has a set point, and you have to constantly trick it because it is going to start to gain weight again,” Ms. Hartman, who is on the national board of directors for the Obesity Action Coalition, said in an interview.

So, 2.5 years after her surgery, Ms. Hartman began weekly subcutaneous injections of the glucagonlike peptide–1 (GLP-1) agonist semaglutide, a medication that is now almost infamous because of its popularity among celebrities and social media influencers.

Branded as Ozempic for type 2 diabetes and Wegovy for obesity, both contain semaglutide but in slightly different doses. The popularity of the medication has led to shortages for those living with type 2 diabetes and/or obesity. And other medications are waiting in the wings that work on GLP-1 and other hormones that regulate appetite, such as the twincretin tirzepatide (Mounjaro), another weekly injection, approved by the Food and Drug Administration in May 2022 for type 2 diabetes and awaiting approval for obesity.

Ms. Hartman said taking semaglutide helped her not only lose weight but also “curb [her] obsessive thoughts over food.” To maintain a BMI within the healthy range, as well as taking the GLP-1 agonist, Ms. Hartman relies on other strategies, including exercise, and mental health support.

“Physicians really need to be open to these FDA-approved medications as one of many tools in the toolbox for patients with obesity. It’s just like any other chronic disease state, when they are thinking of using these, they need to think about long-term use ... in patients who have obesity, not just [among those people] who just want to lose 5-10 pounds. That’s not what these drugs are designed for. They are for people who are actually living with the chronic disease of obesity every day of their lives,” she emphasized.

On average, patients lose 25%-40% of their total body weight following bariatric surgery, said Teresa LeMasters, MD, president of the American Society for Metabolic & Bariatric Surgery. However, there typically is a “small” weight regain after surgery.

“For most patients, it is a small 5-10 pounds, but for some others, it can be significant,” said Dr. LeMasters, a bariatric surgeon at UnityPoint Clinic, Des Moines, Iowa.

“We do still see some patients– anywhere from 10% to 30% – who will have some [significant] weight regain, and so then we will look at that,” she noted. In those cases, the disease of obesity “is definitely still present.”
 

Medications can counter weight regain after surgery

For patients who don’t reach their weight loss goals after bariatric surgery, Dr. LeMasters said it’s appropriate to consider adding an anti-obesity medication. The newer GLP-1 agonists can lead to a loss of around 15% of body weight in some patients.

“The GLP-1 agonists have been very helpful for treating patients who’ve had bariatric surgery and had some weight regain, or even just to optimize their initial response to surgery if they are starting at a very, very severe point of disease,” she explained.

She noted, however, that some patients shouldn’t be prescribed GLP-1 agonists, including those with a history of thyroid cancer or pancreatitis.

Caroline M. Apovian, MD, codirector of the center for weight management and wellness and professor of medicine at Harvard Medical School, Boston, said in an interview that the physiology behind bariatric surgery and that of the newer obesity medications is somewhat aligned.

“In order to reduce ... body weight permanently you need adjustments. We learned that you need the adjustments of the hormones [that affect appetite, such as GLP-1], and that’s why bariatric surgery works because ... [it] provides the most durable and the most effective treatment for obesity ... because [with surgery] you are adjusting the secretion and timing of many of the hormones that regulate body weight,” she explained.

So, when people are taking GLP-1 agonists for obesity, with or without surgery, these medications “are meant and were approved by the FDA to be taken indefinitely. They are not [for the] short term,” Dr. Apovian noted.

Benjamin O’Donnell, MD, an associate professor at Ohio State University Wexner Medical Center, Columbus, agreed that the newer anti-obesity medications can be very effective; however, he expressed uncertainty about prescribing these medications for years and years.

“If somebody has obesity, they need medicine to help them manage appetite and maintain a lower, healthier weight. It would make sense that they would just stay on the medicine,” he noted.

But he qualified: “I have a hard time committing to saying that someone should take this medication for the rest of their life. Part of my hesitation is that the medications are expensive, so we’ve had a hard time with people staying on them, mostly because of insurance formulary changes.”
 

 

 

Why stop the medications? Side effects and lack of insurance coverage

Many people have to discontinue these newer medications for that exact reason.

When Ms. Hartman’s insurance coverage lapsed, she had to go without semaglutide for a while.

“At that time, I absolutely gained weight back up into an abnormal BMI range,” Ms. Hartman said. When she was able to resume the medication, she lost weight again and her BMI returned to normal range.

These medications currently cost around $1,400 per month in the United States, unless patients can access initiatives such as company coupons. Some insurers, including state-subsidized Medicare and Medicaid, don’t cover the new medications.

Dr. O’Donnell said, “More accessibility for more people would help in the big picture.”

Other patients stop taking GLP-1 agonists because they experience side effects, such as nausea.

“Gastrointestinal complaints ... are the number one reason for people to come off the medication,” said Disha Narang, MD, an endocrinologist and obesity medicine specialist at Northwestern Medicine Lake Forest (Ill.) Hospital.

“It is an elective therapy, so it is not mandatory that someone take it. So if they are not feeling well or they are sick, then that’s a major reason for coming off of it,” she said.

Dan Bessesen, MD, professor of medicine at the University of Colorado at Denver, Aurora, and chief of endocrinology, agreed.

Patients are unlikely to stay on these medications if they feel nauseous or experience vomiting, he said. Although he noted there are options to try to counter this, such as starting patients on a very low dose of the drug and up-titrating slowly. This method requires good coordination between the patient and physician.

Goutham Rao, MD, a professor of medicine at Case Western Reserve University and head of the weight-loss initiative Fitter Me at University Hospitals, both in Cleveland, said that prior to prescribing GLP-1 agonists for weight loss, he sets four basic, nonnegotiable goals for patients: “to have breakfast within 30 minutes of getting up, to drink just water, no food or drink after 7:00 p.m. except for water, and 30 minutes of continuous exercise per day, which is typically, for older clientele, walking.”

This, he said, can help establish good habits because if “patients are not engaged psychologically in weight loss ... they expect the medication to do [all] the work.”
 

Most regain weight after stopping obesity medications

As Ms. Hartman’s story illustrates, discontinuing the medications often leads to weight regain.

“Without the medicine, there are a variety of things that will happen. Appetite will tend to increase, and so [patients] will gradually tend to eat more over time,” Dr. Bessesen noted.

“So it may take a long time for the weight regain to happen, but in every study where an obesity medicine has been used, and then it is stopped, the weight goes back to where it was on lifestyle alone,” he added.

In the STEP 1 trial, almost 2,000 patients who were either overweight or living with obesity were randomized 2:1 to semaglutide, titrated up to 2.4 mg each week by week 16, or placebo in addition to lifestyle modification. After 68 weeks, those in the semaglutide group had a mean weight loss of 14.9%, compared with 2.4% in the placebo group.

Patients were also followed in a 1-year extension of the trial, published in Diabetes, Obesity, and Metabolism.

Within 1 year of stopping treatment, participants regained two thirds of the weight they had initially lost.

Hence, Dr. Bessesen stressed that a total rethink of how obesity is approached is needed among most physicians.

“I think in the future treating obesity with medications should be like treating hypertension and diabetes, something most primary care doctors are comfortable doing, but that’s going to take a little work and practice on the part of clinicians to really have a comfortable conversation about risks, and benefits, with patients,” he said.

“I would encourage primary care doctors to learn more about the treatment of obesity, and learn more about bias and stigma, and think about how they can deliver care that is compassionate and competent,” he concluded.

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

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Use age, not weight, to screen for diabetes; assess over 35s

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Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

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Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m2) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m2 and age 35-70 (2021 criteria) and BMI of at least 25 kg/m2 and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m2 and age 30-70, BMI of at least 25 kg/m2 and age 18-70, age 35-70 and BMI of at least 23 kg/m2, and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

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FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE

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Study offers dozens of reasons to cut sugar

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A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

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A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

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Time to rebuild

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A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

Dr. William G. Wilkoff

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

Dr. William G. Wilkoff

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A few months ago, after several months of considerable foot dragging, I wrote that I have accepted the American Academy of Pediatrics’ proclamation that we should begin to treat obesity as a disease.

While it may feel like we are just throwing in the towel, it sounds better if we admit that we may have reached the threshold beyond which total focus on prevention is not going to work.

I continue to be troubled by the lingering fear that, in declaring that obesity is a disease, we will suspend our current efforts at preventing the condition. Granted, most of these efforts at prevention have been woefully ineffective. However, I still believe that, much like ADHD, the rise in obesity in this country is a reflection of some serious flaws in our society. On the other hand, as an inveterate optimist I have not given up on the belief that we will find some yet-to-be-discovered changes in our societal fabric that will eventually turn the ship around.

Dr. William G. Wilkoff

With this somewhat contradictory combination of resignation and optimism in mind, I continue to seek out studies that hold some promise for prevention while we begin tinkering with the let’s-treat-it-like-a-disease approach.

I recently discovered a story about one such study from the Center for Economic and Social Research at the University of Southern California. Using data collected about adolescent dependents of military personnel, the researchers found that “exposure to a more advantageous built environment for more than 2 years was associated with lower probabilities of obesity.” Because more than half of these teenagers were living in housing that had been assigned by the military, the researchers could more easily control for a variety of factors some related to self-selection.

Interestingly, the data did not support associations between the adolescents’ diet, physical activity, or socioeconomic environments. The investigators noted that “more advantageous built environments were associated with lower consumption of unhealthy foods.” However, the study lacked the granularity to determine what segments of the built environment were most associated with the effect they were observing.

Like me, you may not be familiar with the term “built environment.” Turns out it is just exactly what we might expect – anything about the environment that is the result of human action – buildings, roadways, dams, neighborhoods – and what they do and don’t contain. For example, is the adolescent living in an environment that encourages walking or one that is overly motor vehicle–centric? Does his or her neighborhood have easily reachable grocery stores that offer a range of healthy foods or does the teenager live in a nutritional desert populated only by convenience stores? Is there ample space for outdoor physical activity?

The authors’ observation that the adolescents who benefited from living in advantageous environments had a lower consumption of unhealthy foods might suggest that access to a healthy diet might be a significant factor. For me, the take-home message is that in our search for preventive strategies we have barely scratched the surface. The observation that the associations these researchers were making was over a relatively short time span of 2 years should give us hope that if we think more broadly and creatively we may be to find solutions on a grand scale.

Over the last century we have built an environment that is clearly obesogenic. This paper offers a starting point from which we can learn which components of that environment are the most potent contributors to the obesity epidemic. Once we have that information the question remains: Can we find the political will to tear down and rebuilt?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

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