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Should CGM be used for those without diabetes?

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Changed
Wed, 05/10/2023 - 09:42

Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.

“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”

Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.

Companies such as Levels, Signos, and Nutrisense offer CGM services to people interested in weight management or who are curious about how their bodies react to certain foods as the technology provides continuous feedback. This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.

These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.

This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
 

‘Everyone wants a CGM’

“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.

David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”

People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.

David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.

Dr. David T. Ahn


“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”

And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.

But does knowing all this result in behavioral changes?

Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.

Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.

And there’s no scientific proof that CGM use in those without diabetes has any impact.

“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.

Diana Isaacs, PharmD


A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.

Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.

“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.

“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.

 

 

Are CGMs too expensive, and can the information overwhelm some?

The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”

The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.

If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.

“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”

Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”

Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.

And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”

But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.

Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.

Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
 

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

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Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.

“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”

Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.

Companies such as Levels, Signos, and Nutrisense offer CGM services to people interested in weight management or who are curious about how their bodies react to certain foods as the technology provides continuous feedback. This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.

These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.

This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
 

‘Everyone wants a CGM’

“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.

David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”

People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.

David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.

Dr. David T. Ahn


“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”

And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.

But does knowing all this result in behavioral changes?

Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.

Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.

And there’s no scientific proof that CGM use in those without diabetes has any impact.

“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.

Diana Isaacs, PharmD


A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.

Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.

“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.

“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.

 

 

Are CGMs too expensive, and can the information overwhelm some?

The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”

The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.

If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.

“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”

Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”

Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.

And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”

But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.

Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.

Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
 

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

Dallas Waldon doesn’t have diabetes, but she says she benefits from continuous glucose monitoring (CGM). “I’m a huge fan of CGMs and used them before, during, and after my pregnancy, [up to] 6 months postpartum, I’m down 11 pounds from my prepregnancy weight,” said Ms. Waldon, a manager for a land-buying company who lives in El Dorado, Calif.

“CGMs bring a certain level of accountability to what you’re eating. You can’t pretend you didn’t eat that cookie while making the kids’ lunch, or that the latte you had was ‘just coffee,’ ” she said. “You have the hard numbers to answer to, and that makes you think twice before putting anything in your mouth.”

Ms. Waldon is not alone. Although CGMs are typically used by people with type 1 diabetes, and increasingly those with type 2 diabetes, some endocrinologists say they are seeing an increased demand for CGM use from individuals who don’t have diabetes.

Companies such as Levels, Signos, and Nutrisense offer CGM services to people interested in weight management or who are curious about how their bodies react to certain foods as the technology provides continuous feedback. This allows users to monitor the glucose level and see how eating and exercise affects it. The companies claim that CGM use will help motivate individuals to eat better and maximize their exercise, and therefore consequently lose weight.

These lifestyle programs typically offer users the FreeStyle Libre (Abbott Laboratories). It uses a coin-sized sensor, generally worn on the upper arm, which lasts 14 days and measures glucose in the interstitial fluid. Users can read their glucose levels via an app on their smartphones as many times a day as they want. The FreeStyle Libre is worn by many people with diabetes and is a simple CGM to use, said Anne Peters, MD, professor of clinical medicine, University of Southern California, Los Angeles.

This growing demand for CGM use among healthy people is driven by an increasing “fascination” for monitoring every bodily function, as can be seen by the popularity of smart devices such as Fitbits and Apple watches, Dr. Peters added. These devices allow users to see their heart rates, review their sleep patterns, and monitor their pulses in real time; a CGM is an extension of that by providing up-to-the-minute glucose monitoring.
 

‘Everyone wants a CGM’

“Everyone wants a CGM,” Dr. Peters said, noting that even family members of her patients with diabetes are asking for them. She admits that their use can be effective for those who are prediabetic so they can see their glycemic responses to food. For instance, someone who typically eats oatmeal for breakfast may see their blood glucose increase, meaning they might want to lower their carbs.

David Klonoff, MD, medical director of the Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, Calif., agrees that there has been an increase in use by people who don’t have diabetes as CGMs offer information they wouldn’t otherwise have access to “without having to prick themselves many times.”

People are using CGMs to monitor how high their blood glucose rises after eating certain foods, the length of time it takes to reach peak levels, and how quickly levels drop, he added. Elite athletes are using CGMs to ensure that they are consuming enough calories to avoid hypoglycemia, Dr. Klonoff said.

David T. Ahn, MD, program director at the Mary & Dick Allen Diabetes Center at Hoag Hospital in Newport Beach, Calif., also believes that the devices can provide useful information. “I find that CGM helps people learn a lot about nutrition and how lifestyle choices like food, activity, and stress impact their own physiology,” he stated.

Dr. David T. Ahn


“For example, comparing glucose spikes after different [types of] meals can deepen people’s understanding of carbohydrates vs. protein, or high glycemic index foods vs. low glycemic index foods,” he continued. “In addition, if a patient chooses to follow a very low-carbohydrate diet and/or an intermittent fasting diet, a CGM can be a powerful tool to measure consistency with that lifestyle choice.”

And for a person without diabetes, wearing a CGM provides a way to have personalized information on other physiologic measures, part of the quantified self movement where users log and track their blood pressure, urine output, and oxygen saturation, among other things, Dr. Klonoff said.

But does knowing all this result in behavioral changes?

Dr. Ahn isn’t sure. “For many people, being able to see glucose excursions throughout the day and after meals can be extremely educational and motivating. But much like the Fitbit or Apple Watch, simply wearing [a CGM] ... does not translate to behavior change. The CGM data patterns in someone without diabetes can start to become predictable over time, leading to a drop-off in utility/adherence after the initial education period,” he said.

Dr. Peters said she too isn’t convinced about the long-term worth of CGM in promoting or sustaining behavioral change, as the “novelty” of tracking may wear off after a few months.

And there’s no scientific proof that CGM use in those without diabetes has any impact.

“While there are many programs that offer coaching with CGM data, we need more studies to determine if this leads to improved outcomes like weight loss and prevention, or delay in the development of diabetes,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, director of education and training in diabetes technology at Cleveland Clinic Diabetes Center.

Diana Isaacs, PharmD


A 2019 study published in the Journal of Clinical Endocrinology and Metabolism found that the blood glucose of individuals without diabetes using a CGM was in the “ideal” range between 70 mg/dL and 140 mg/dL 96% of the time. “Their glucose was beautifully controlled,” said Dr. Peters, who was one of the study authors.

Currently there aren’t any studies evaluating patterns among healthy individuals wearing CGMs, Dr. Klonoff noted, but he predicts that those studies will be done in the future to examine metabolic patterns that might contribute to someone developing prediabetes or diabetes.

“More data are needed from studies that focus on individuals at risk for diabetes to better understand the role of CGM in these cases, and how to best interpret and utilize the results,” said Fida Bacha, MD, a diabetes and endocrinology specialist and associate professor of pediatrics at Baylor College of Medicine in Houston.

“If clear metrics are identified to predict the progression to diabetes, then this would be worthwhile for early detection and prevention of the disease,” Dr. Bacha said.

 

 

Are CGMs too expensive, and can the information overwhelm some?

The biggest obstacle to many people using CGM is cost. “The main downside of using a CGM without diabetes is cost, since insurance won’t usually cover a CGM if the patient does not have diabetes,” said Marilyn Tan, MD, FACE, chief of the Endocrine Clinic, Stanford Health Clinic, Palo Alto, Calif. “Even for patients with diabetes but not on insulin, CGM coverage can be challenging, as out-of-pocket costs for CGM are variable.”

The lifestyle companies mentioned above charge $139-$399 per month, which covers two CGM sensors, each one good for 14 days. Users need to subscribe to a plan for service and delivery. Additional services such as nutrition counseling may be available at an additional cost. Because CGMs in the United States require a prescription, these companies offer web screening and access to a web-based provider.

If healthy patients feel that the informational value of CGMs is worth the money, then they shouldn’t be discouraged, the experts believe.

“There’s little risk of harm with wearing a CGM,” Dr. Tan said, although she acknowledges that “[t]oo much information can also be overwhelming for some individuals.”

Users need to consult with their clinicians to ensure they understand the readings, Dr. Peters said. “You have to tell them not to overreact if the device reads low [glucose] or not to freak out if they get an alarm.” A high glucose reading, indicating hyperglycemia, can be caused by a steroid injection, or older people may experience a postprandial high after eating, she added. “They need to talk to their healthcare provider to interpret the data especially if they are out of [the ideal glucose] range.”

Dr. Klonoff agreed that there is a risk of people trying to “medicalize” too much information. “If you have a fever, you don’t have to go to a doctor to know you have an infection,” he said.

And the point, he added, is not to obsess over the individual numbers but to look for patterns particularly as predictors of metabolic syndrome. If a patient’s glucose is primarily in range, he or she wouldn’t necessarily worry about diabetes. But if it’s out of range more than 10% of the time, it might mean that patient is at risk for diabetes. “It might be time to counsel the patient to eat healthier and exercise more,” he said. “It’s never wrong to steer people to a healthier lifestyle.”

But another issue is whether the numbers from CGMs are entirely accurate in people without diabetes. A 2020 study published in the American Journal of Clinical Nutrition had 16 adults without diabetes wear both the Dexcom G4 Platinum CGM and Abbott FreeStyle Libre Pro for 28 days.

Researchers found that mean postprandial glucose was higher with the Dexcom than with the Abbott system, suggesting that “postprandial glycemic excursions were somewhat inconsistent between the CGMs.” The authors concluded that it may be too early to personalize meal recommendations via CGM.

Dr. Isaacs said perhaps the happy medium is for those without diabetes to just use CGMs occasionally. “It’s ... unclear [if] the right [use] of CGM needs to be continuous or if periodic use, such as once every 3 months, is enough for benefits,” she concluded.
 

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

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Statins tied to lower stroke risk in atrial fibrillation

Article Type
Changed
Fri, 05/05/2023 - 10:09

Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.

Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.

Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.

“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.

The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
 

Widely prescribed

Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”

Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.

The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.

The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.

Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.



“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.

These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.

Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”

“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”

When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.

It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”

Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.

He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”

The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.

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

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Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.

Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.

Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.

“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.

The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
 

Widely prescribed

Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”

Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.

The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.

The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.

Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.



“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.

These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.

Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”

“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”

When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.

It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”

Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.

He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”

The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.

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

Among patients with atrial fibrillation (AFib), initiation of statins soon after diagnosis was protective against stroke and related vascular events, and longer duration of use was associated with greater protection, a new cohort study shows.

Statin use was associated with lower risks of ischemic stroke or systemic embolism, hemorrhagic stroke, and transient ischemic attack (TIA), regardless of whether patients were also taking anticoagulant medications.

Lead author Jiayi Huang, a PhD student at Hong Kong University at Shenzhen (China) Hospital, concluded that the study’s findings support the use of statins to prevent stroke for patients with new-onset AFib.

“The findings have important clinical implications, particularly given that in atrial fibrillation, patients’ ischemic strokes are often fatal or disabling and have a high risk of recurrence,” she said.

The results were presented in a moderated poster session at the European Heart Rhythm Association 2023 Congress.
 

Widely prescribed

Anticoagulant drugs are prescribed to lower the fivefold increased risk of stroke among individuals with AFib, compared with those without AFib, but the therapy does not eliminate the higher risk, Ms. Huang explained. And although statins are widely prescribed to reduce the likelihood of myocardial infarction and stroke, “the benefit of statins for stroke prevention in patients with atrial fibrillation has been unclear.”

Ms. Huang and colleagues analyzed data from 51,472 patients newly diagnosed with AFib between 2010 and 2018. The population was divided into statin users (n = 11,866), defined as patients who had taken statins for at least 19 consecutive days in the first year after AFib diagnosis, and statin nonusers (n = 39,606), based on whether they were prescribed statin therapy after their first diagnosis of AFib.

The median age of the cohort was 74.9 years, and 47.7% were women. The investigators used statistical methods to balance baseline covariates between the two groups.

The primary outcomes were ischemic stroke or systemic embolism, hemorrhagic stroke, and TIA. Median follow-up was 5.1 years.

Statin use was associated with a significantly lower risk of all outcomes, compared with nonuse. Statin users had a 17% reduced risk of ischemic stroke or systemic embolism, a 7% reduced risk of hemorrhagic stroke, and a 15% rate of reduced risk of TIA, Ms. Huang reported.



“We also found long-term statin use was associated with greater protection than short-term use,” she said. For statin use of 6 years or longer, in comparison with use of 3 months to 2 years, the risk of ischemic stroke or systemic embolism was lowered by 43%; for hemorrhagic stroke, it was lowered by 44%, and for TIA, it was lowered by 42%.

These associations were consistent regardless of whether patients used anticoagulant medications or the type of anticoagulant.

Oussama Wazni, MD, MBA, section head of cardiac electrophysiology and pacing at the Cleveland Clinic, was a moderator of the poster session at which Ms. Huang presented her study. In an interview, he called the study “very important.”

“The message should be that all patients who have atrial fibrillation should be checked for cholesterol levels, and we should consider placing them on statins,” he said. “Is there an opportunity? Probably there is, and that’s why we’re seeing this effect in this group of patients.”

When asked about a possible mechanism by which statins produced the effects seen in the study, he pointed to LDL cholesterol lowering and possibly an effect on inflammation. “If a patient had a carotid atheroma, for example, maybe it helped with that,” he said. Previous work has shown that inflammation is related to or is associated with higher risk of thrombogenic effects, including MI or stroke.

It may be a bit less clear how statins reduced the incidence of hemorrhagic strokes, but Dr. Wazni proposed that some strokes could have started as an ischemic stroke “and then had hemorrhagic conversion, so we don’t have the granularity in here to know whether that was the case or not.”

Given the fact that the effect was stronger the longer a patient had been taking a statin, Dr. Wazni said that if a patient is tolerating the drug well, there should be no reason to discontinue it, regardless of age.

He said the study provides “welcome data and evidence because it’s pointing in the right direction,” but prospective studies would be useful “so that we can see what is driving what. Otherwise, this is just an association.”

The study was supported by Sanming Project Shenzhen. Ms. Huang and Dr. Wazni disclosed no relevant financial relationships.

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

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Lifestyle med experts tell how to deprescribe diabetes meds

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Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.

The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.

“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”

“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.” 

According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”

The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.

“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.

“The protocols presented can serve as a model for how to do so,” she continued.

The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.

According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.

“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”

In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.

To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.

“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”

“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.

Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
 

 

 

Deprescribing antiglycemic meds in lifestyle medicine

Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.  

In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.

Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.

Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.

Most practitioners work with a team of allied health care providers.

During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.

Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.

Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.

Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.

Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.

Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.

The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.

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

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Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.

The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.

“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”

“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.” 

According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”

The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.

“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.

“The protocols presented can serve as a model for how to do so,” she continued.

The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.

According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.

“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”

In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.

To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.

“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”

“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.

Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
 

 

 

Deprescribing antiglycemic meds in lifestyle medicine

Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.  

In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.

Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.

Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.

Most practitioners work with a team of allied health care providers.

During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.

Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.

Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.

Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.

Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.

Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.

The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.

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

Nine lifestyle medicine practitioners describe how they safely and effectively deprescribe glucose-lowering medications after patients demonstrate a reduced need for such medications following lifestyle changes.

The report by Michael D. Bradley, PharmD, and colleagues was recently published as a feature article in Clinical Diabetes.

“Lifestyle medicine uses an evidence-based lifestyle therapeutic approach to treat lifestyle-related chronic disease,” they wrote, and it includes “a whole-food, predominantly plant-based eating plan, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection.”

“Medication deprescribing,” senior author Micaela C. Karlsen, PhD, said in an email, “is a planned and supervised process of dose reduction or discontinuation of a medication that may be causing harm, or no longer providing benefit to a patient.” 

According to the authors, the article “is the first account published of the medication de-escalation methods used by lifestyle medicine providers when patients demonstrate a decreased need for pharmacotherapy.” It “supports the feasibility of de-escalating glucose-lowering medications in this context and provides pilot data on protocols from individual practitioners experienced in deprescribing glucose-lowering medications.”

The study was not designed to cover deprescribing glucose-lowering medications following weight loss and diabetes remission after bariatric surgery.

“A key takeaway [from the current study] for general practitioners and endocrinologists is that, while deprescribing is already known to be beneficial to reduce polypharmacy, it may be appropriate following lifestyle interventions,” said Dr. Karlsen, who is senior director of the American College of Lifestyle Medicine in Chesterfield, Md.

“The protocols presented can serve as a model for how to do so,” she continued.

The American Diabetes Association and the American Association of Clinical Endocrinology recommend lifestyle optimization as part of medical care for type 2 diabetes.

According to the ACLM, “remission of type 2 diabetes should be a clinical goal and may be achieved with a whole-food, plant-based dietary pattern coupled with moderate exercise,” the researchers noted.

“Remission,” they wrote, “can be defined as attainment of a [hemoglobin] A1c less than 6.5% for at least 3 months with no surgery, devices, or active pharmacologic therapy for the specific purpose of lowering blood glucose.”

In ACLM’s recent expert consensus statement on dietary interventions for type 2 diabetes remission, which was also endorsed by AACE, supported by the Academy of Nutrition and Dietetics, and cosponsored by the Endocrine Society, panel members agreed that remission is a realistic and achievable goal for some adults with type 2 diabetes, and a high-intensity dietary intervention can result in remission, Dr. Karlsen said.

To avoid hypoglycemia when deprescribing antiglycemic drugs, medications known to cause hypoglycemia – notably sulfonylurea and insulin – are often deprescribed first, she noted.

“Our biggest hope,” she said, “is that [type 2 diabetes] remission may come to the forefront as a clinical goal in treatment and that other organizations will more strongly emphasize lifestyle in standards of care.”

“We hope that clinicians reading this paper will be made aware that de-escalation of glucose-lowering medications is feasible, is a desirable outcome, and can be necessary in a lifestyle medicine context,” she added.

Further research is needed to prospectively track the likelihood of type 2 diabetes remission, factors that predict successful remission, and decision-making protocols followed by practitioners, Dr. Karlsen said.
 

 

 

Deprescribing antiglycemic meds in lifestyle medicine

Researchers at the Bruyère Research Institute, Ottawa, and Université de Montréal provide algorithms for deprescribing antihyperglycemic medications specifically for older individuals.  

In the current study, the authors conducted individual, 30-minute to 1-hour interviews with nine lifestyle medicine practitioners to document their protocols for deprescribing glucose-lowering medications after lifestyle interventions with a goal of potential type 2 diabetes remission.

Three practitioners reported medication deprescribing in an intensive therapeutic lifestyle program (longer, more frequent treatment with greater monitoring). The others provide deprescribing in a nonintensive program (similar to primary care practice) or both.

Deprescribing is necessary when using intensive therapeutic lifestyle change, as substantial and rapid drops in glucose levels aren’t adjusted for, the authors noted.

Most practitioners work with a team of allied health care providers.

During the deprescribing process, most protocols require that patients get a basic or comprehensive metabolic panel of blood tests, with variations in laboratory tests for A1c, C-peptide, and renal function.

Most practitioners recommend a target blood glucose less than 120 mg/dL for further deprescribing.

Currently, there is no clinical guidance for use of continuous glucose monitoring (CGM) during medication de-escalation, the authors note.

Most practitioners reported they consider patient expenses associated with CGM and third-party payor coverage in their decision-making.

Most practitioners prefer to deprescribe sulfonylureas, insulin, and other medications known to cause hypoglycemia first.

Conversely, most prefer to defer deprescribing medications that have demonstrated cardiovascular and/or renal benefits (that is, glucagonlike peptide–1 receptor agonists and sodium-glucose cotransporter 2 inhibitors), as well as those with a less severe adverse effect profile (that is, metformin and GLP-1 receptor agonists) until after other medications are deprescribed.

The study was funded by the Ardmore Institute of Health. The authors reported no relevant financial relationships.

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

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10 popular diets for heart health ranked

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Mon, 05/08/2023 - 08:41

An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.

A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.

“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.

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“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.

The statement was published online  in Circulation.
 

A tool for clinicians

“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.

“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.

The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.

That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.

The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.

The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.

Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.

The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.

The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.

“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.

Vegan and low-fat diets (each with a score of 78) fell into the second tier.

Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.

There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.

The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.

Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”

“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.

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

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An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.

A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.

“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.

Lisovskaya/iStock/Getty Images


“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.

The statement was published online  in Circulation.
 

A tool for clinicians

“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.

“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.

The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.

That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.

The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.

The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.

Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.

The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.

The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.

“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.

Vegan and low-fat diets (each with a score of 78) fell into the second tier.

Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.

There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.

The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.

Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”

“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.

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

An evidence-based analysis of 10 popular dietary patterns shows that some promote heart health better than others.

A new American Heart Association scientific statement concludes that the Mediterranean, Dietary Approach to Stop Hypertension (DASH), pescatarian, and vegetarian eating patterns most strongly align with heart-healthy eating guidelines issued by the AHA in 2021, whereas the popular paleolithic (paleo) and ketogenic (keto) diets fall short.

“The good news for the public and their clinicians is that there are several dietary patterns that allow for substantial flexibility for following a heart healthy diet – DASH, Mediterranean, vegetarian,” writing-group chair Christopher Gardner, PhD, with Stanford (Calif.) University, told this news organization.

Lisovskaya/iStock/Getty Images


“However, some of the popular diets – particularly paleo and keto – are so strictly restrictive of specific food groups that when these diets are followed as intended by their proponents, they are not aligned with the scientific evidence for a heart-healthy diet,” Dr. Gardner said.

The statement was published online  in Circulation.
 

A tool for clinicians

“The number of different, popular dietary patterns has proliferated in recent years, and the amount of misinformation about them on social media has reached critical levels,” Dr. Gardner said in a news release.

“The public – and even many health care professionals – may rightfully be confused about heart-healthy eating, and they may feel that they don’t have the time or the training to evaluate the different diets. We hope this statement serves as a tool for clinicians and the public to understand which diets promote good cardiometabolic health,” he noted.

The writing group rated on a scale of 1-100 how well 10 popular diets or eating patterns align with AHA dietary advice for heart-healthy eating.

That advice includes consuming a wide variety of fruits and vegetables; choosing mostly whole grains instead of refined grains; using liquid plant oils rather than tropical oils; eating healthy sources of protein, such as from plants, seafood, or lean meats; minimizing added sugars and salt; limiting alcohol; choosing minimally processed foods instead of ultraprocessed foods; and following this guidance wherever food is prepared or consumed.

The 10 diets/dietary patterns were DASH, Mediterranean-style, pescatarian, ovo-lacto vegetarian, vegan, low-fat, very low–fat, low-carbohydrate, paleo, and very low–carbohydrate/keto patterns.

The diets were divided into four tiers on the basis of their scores, which ranged from a low of 31 to a high of 100.

Only the DASH eating plan got a perfect score of 100. This eating pattern is low in salt, added sugar, tropical oil, alcohol, and processed foods and high in nonstarchy vegetables, fruits, whole grains, and legumes. Proteins are mostly plant-based, such as legumes, beans, or nuts, along with fish or seafood, lean poultry and meats, and low-fat or fat-free dairy products.

The Mediterranean eating pattern achieved a slightly lower score of 89 because unlike DASH, it allows for moderate alcohol consumption and does not address added salt.

The other two top tier eating patterns were pescatarian, with a score of 92, and vegetarian, with a score of 86.

“If implemented as intended, the top-tier dietary patterns align best with the American Heart Association’s guidance and may be adapted to respect cultural practices, food preferences and budgets to enable people to always eat this way, for the long term,” Dr. Gardner said in the release.

Vegan and low-fat diets (each with a score of 78) fell into the second tier.

Though these diets emphasize fruits, vegetables, whole grains, legumes, and nuts while limiting alcohol and added sugars, the vegan diet is so restrictive that it could be challenging to follow long-term or when eating out and may increase the risk for vitamin B12 deficiency, which can lead to anemia, the writing group notes.

There also are concerns that low-fat diets treat all fats equally, whereas the AHA guidance calls for replacing saturated fats with healthier fats, they point out.

The third tier includes the very low–fat diet (score 72) and low-carb diet (score 64), whereas the paleo and very low–carb/keto diets fall into the fourth tier, with the lowest scores of 53 and 31, respectively.

Dr. Gardner said that it’s important to note that all 10 diet patterns “share four positive characteristics: more veggies, more whole foods, less added sugars, less refined grains.”

“These are all areas for which Americans have substantial room for improvement, and these are all things that we could work on together. Progress across these aspects would make a large difference in the heart-healthiness of the U.S. diet,” he told this news organization.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Lifestyle and Cardiometabolic Health, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, and the Council on Peripheral Vascular Disease.

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

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Medications provide best risk-to-benefit ratio for weight loss, says expert

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– For patients with obesity, surgery, lifestyle changes, and pharmacologic interventions are all treatment options, but antiobesity medications provide a better risk-to-benefit ratio, according to a presenter at the annual meeting of the American College of Physicians.

Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.

New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.

Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
 

Older FDA-approved antiobesity medications

Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.

Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.

“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.

Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
 

Newer anti‐obesity medications

Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”

Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”

Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.

Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
 

 

 

Emerging antiobesity medications

Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.

A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
 

A ‘holistic approach’

When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.

He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.

Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.

“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”

Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.

Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.

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– For patients with obesity, surgery, lifestyle changes, and pharmacologic interventions are all treatment options, but antiobesity medications provide a better risk-to-benefit ratio, according to a presenter at the annual meeting of the American College of Physicians.

Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.

New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.

Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
 

Older FDA-approved antiobesity medications

Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.

Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.

“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.

Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
 

Newer anti‐obesity medications

Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”

Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”

Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.

Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
 

 

 

Emerging antiobesity medications

Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.

A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
 

A ‘holistic approach’

When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.

He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.

Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.

“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”

Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.

Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.

– For patients with obesity, surgery, lifestyle changes, and pharmacologic interventions are all treatment options, but antiobesity medications provide a better risk-to-benefit ratio, according to a presenter at the annual meeting of the American College of Physicians.

Lifestyle changes result in the least weight loss and may be safest, while surgery provides the most weight loss and has the greatest risk. Antiobesity medications, especially the newer ones used in combination with lifestyle changes, can provide significant and sustained weight loss with manageable side effects, said Daniel Bessesen, MD, a professor in the endocrinology, diabetes, and metabolism at University of Colorado at Denver, Aurora.

New and more effective antiobesity medications have given internists more potential options to discuss with their patients, Dr. Bessesen said. He reviewed the pros and cons of the different options.

Medications are indicated for patients with a body mass index greater than 30, including those with a weight-related comorbidity, Dr. Bessesen said. The average weight loss is 5%-15% over 3-6 months but may vary greatly. Insurance often does not cover the medication costs.
 

Older FDA-approved antiobesity medications

Phentermine is the most widely prescribed antiobesity medication, partly because it is the only option most people can afford out of pocket. Dr. Bessesen presented recent data showing that long-term use of phentermine was associated with greater weight loss and that patients continuously taking phentermine for 24 months lost 7.5% of their weight.

Phentermine suppresses appetite by increasing norepinephrine production. Dr. Bessesen warned that internists should be careful when prescribing it to patients with mental conditions, because it acts as a stimulant. Early studies raised concerns about the risk of cardiovascular disease (CVD) in patients taking phentermine. However, analysis of data from over 13,000 individuals showed no evidence of a relationship between phentermine exposure and CVD events.

“These data provide some reassurance that it could be used in patients with CVD risk,” he noted. Phentermine can also be combined with topiramate extended release, a combination that provides greater efficacy (up to 10% weight loss) with fewer side effects. However, this combination is less effective in patients with diabetes than in those without.

Additional treatment options included orlistat and naltrexone sustained release/bupropion SR. Orlistat is a good treatment alternative for patients with constipation and is the safest option among older anti-obesity medications, whereas naltrexone SR/bupropion SR may be useful in patients with food cravings. However, there is more variability in the individual-level benefit from these agents compared to phentermine and phentermine/topiramate ER, Dr. Bessesen said.
 

Newer anti‐obesity medications

Liraglutide, an agent used for the management of type 2 diabetes, has recently been approved for weight loss. Liraglutide causes moderate weight loss, and it may reduce the risk of CVD. However, there are tolerability issues, such as nausea and other risks, and Dr. Bessesen advises internists to “start at low doses and increase slowly.”

Semaglutide is the newest and most effective antiobesity drug approved by the Food and Drug Administration, providing sustained weight loss of 8% for up to 48 weeks after starting treatment. Although its efficacy is lower in patients with diabetes, Dr. Bessesen noted that “this is common for antiobesity agents, and clinicians should not refrain from prescribing it in this population.”

Setmelanotide is another new medication approved for chronic weight management in patients with monogenic obesity. This medication can be considered for patients with early-onset severe obesity with abnormal feeding behavior.

Commenting on barriers to access to new antiobesity medications, Dr. Bessesen said that “the high cost of these medications is a substantial problem, but as more companies become involved and products are on the market for a longer period of time, I am hopeful that prices will come down.”
 

 

 

Emerging antiobesity medications

Dr. Bessesen presented recent phase 3 data showing that treatment with tirzepatide provided sustained chronic loss and improved cardiometabolic measures with no diet. Tirzepatide, which targets receptors for glucagonlike peptide–1 and glucose-dependent insulinotropic polypeptide, is used for the management of type 2 diabetes and is expected to be reviewed soon by the FDA for its use in weight management.

A semaglutide/cagrilintide combination may also provide a new treatment option for patients with obesity. In a phase 1b trial, semaglutide/cagrilintide treatment resulted in up to 17% weight loss in patients with obesity who were otherwise healthy; however, phase 2 and 3 data are needed to confirm its efficacy.
 

A ‘holistic approach’

When deciding whether to prescribe antiobesity medications, Dr. Bessesen noted that medications are better than exercise alone. Factors to consider when deciding whether to prescribe drugs, as well as which ones, include costs, local regulatory guidelines, requirement for long-term use, and patient comorbidities.

He also stated that lifestyle changes, such as adopting healthy nutrition and exercising regularly, are also important and can enhance weight loss when combined with medications.

Richele Corrado, DO, MPH, agreed that lifestyle management in combination with medications may provide greater weight loss than each of these interventions alone.

“If you look at the data, exercise doesn’t help you lose much weight,” said Dr. Corrado, a staff internist and obesity medicine specialist at Walter Reed National Military Medical Center in Bethesda, Md., who spoke at the same session. She added that she has many patients who struggle to lose weight despite having a healthy lifestyle. “It’s important to discuss with these patients about medications and surgery.”

Dr. Bessesen noted that management of mental health and emotional well-being should also be an integral part of obesity management. “Treatment for obesity may be more successful when underlying psychological conditions such as depression, childhood sexual trauma, or anxiety are addressed and treated,” he said.

Dr. Bessesen was involved in the study of the efficacy of semaglutide/cagrilintide. He does not have any financial conflicts with the companies that make other mentioned medications. He has received research grants or contracts from Novo Nordisk, honoraria from Novo Nordisk, and consultantship from Eli Lilly. Dr. Corrado reported no relevant financial conflicts.

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AHA backs screening for cognitive impairment after stroke

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Fri, 05/05/2023 - 10:18

Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

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Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

Screening for cognitive impairment should be part of multidisciplinary care for stroke survivors, the American Heart Association says in a new scientific statement.

“Cognitive impairment after stroke is very common, is associated with other post-stroke outcomes, and often has significant impact on the quality of life,” Nada El Husseini, MD, MHSc, chair of the scientific statement writing group, told this news organization.

“It is important to screen stroke survivors for cognitive impairment as well as for associated comorbidities such as mood and sleep disorders,” said Dr. El Husseini, associate professor of neurology at Duke University Medical Center in Durham, N.C.

The scientific statement was published online in Stroke. It’s the first to specifically focus on the cognitive impairment resulting from an overt stroke (ischemic or hemorrhagic).
 

‘Actionable’ considerations for care

The writing group performed a “scoping” review of the literature on the prevalence, diagnosis, and management of poststroke cognitive impairment (PSCI) to provide a framework for “actionable considerations” for clinical practice as well as to highlight gaps needing additional studies, Dr. El Husseini explained.

PSCI, ranging from mild to severe, occurs in up to 60% of stroke survivors in the first year after stroke; yet, it is often underreported and underdiagnosed, the writing group notes.

Up to 20% of stroke survivors who experience mild cognitive impairment fully recover cognitive function, and cognitive recovery is most likely within the first 6 months after a stroke.

However, improvement in cognitive impairment without return to prestroke levels is more frequent than is complete recovery. As many as one in three stroke survivors may develop dementia within 5 years of stroke.

The writing group also notes that PSCI is often associated with other conditions, including physical disability, sleep disorders, behavioral and personality changes, depression, and other neuropsychological changes – each of which may contribute to lower quality of life.

Currently, there is no “gold standard” for cognitive screening following stroke, but several brief cognitive screening tests, including the Mini–Mental State Examination and the Montreal Cognitive Assessment, are widely used to identify cognitive impairment after stroke.

The statement also highlights the importance of assessing cognitive changes over time after stroke. Stroke survivors who experience unexplained difficulties with cognitive-related activities of daily living, following care instructions, or providing a reliable health history may be candidates for additional cognitive screening.
 

Manage risk factors to prevent repeat stroke

“Anticipatory guidance regarding home and driving safety and, return to work (if applicable) along with interdisciplinary collaboration among different medical and ancillary specialists in the diagnosis and management of cognitive impairment is key for the holistic care of stroke survivors,” Dr. El Husseini told this news organization.

The multidisciplinary poststroke health care team could include neurologists, occupational therapists, speech therapists, nurses, neuropsychologists, gerontologists, and primary care providers.

“Because recurrent stroke is strongly associated with the development of cognitive impairment and dementia, prevention of recurrent strokes should be sought to decrease that risk,” Dr. El Husseini said. This includes addressing stroke risk factors, including high blood pressure, high cholesterol, type 2 diabetes, and atrial fibrillation.

The writing group says research is needed in the future to determine how cognitive impairment develops after stroke and the impact of nonbrain factors, including infection, frailty, and social factors.

Further research is also needed to determine best practices for cognitive screening after stroke, including the development and use of screening instruments that consider demographic, cultural, and linguistic factors in determining “normal” function.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for poststroke cognitive impairment,” Dr. El Husseini said in a news release.

“We hope to see big enough clinical trials that assess various techniques, medications, and lifestyle changes in diverse groups of patients that may help improve cognitive function,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular Radiology and Intervention, the Council on Hypertension, and the Council on Lifestyle and Cardiometabolic Health.
 

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Step count–heart rate link confirmed in children

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Fri, 05/05/2023 - 10:22

Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

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Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

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Long-COVID rate may be higher with rheumatic diseases

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Tue, 05/02/2023 - 17:46

Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News
Dr. Arvind Nune

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Jeffrey A. Sparks

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

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Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News
Dr. Arvind Nune

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Jeffrey A. Sparks

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News
Dr. Arvind Nune

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Jeffrey A. Sparks

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

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Pustules on face

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Pustules on face

Pustules on face

A review of the patient’s chemotherapy medications revealed that 4 weeks earlier, panitumumab had been added to her folinic acid, fluorouracil, and irinotecan (FOLFIRI) regimen. The physician diagnosed this acneiform eruption as an adverse effect of the panitumumab.

Panitumumab is a monoclonal antibody that works to inhibit epidermal growth factor receptor (EGFR) proteins that are overexpressed on some solid tumors and responsible for cancer cell proliferation. EGFR inhibitor–induced acneiform eruptions are common in patients receiving panitumumab.

EGFR proteins have been a target of chemotherapy since the approval of the small molecule erlotinib in 2004. Panitumumab and cetuximab are monoclonal antibodies targeting EGFR and improve long-term survival in patients with metastatic colorectal cancer when added to other standard chemotherapy regimens. EGFR is found throughout the epidermis and all EGFR inhibitors may cause unique skin toxicity not seen with other chemotherapy agents. In 1 study of 229 patients, 59% of patients exhibited skin toxicity at Day 15; the most common examples included widespread acne-like papules and pustules or an eczema-like manifestation.1 Eruptions may be worsened by significant sun exposure while on panitumumab. In this case, the acneiform eruption occurred more intensely along visible facial telangiectasias.

When EGFR inhibitor–induced acneiform eruption occurs, patients commonly develop skin toxicity within the first 2 to 4 weeks of therapy. Pre-therapy doxycycline or minocycline and/or topical steroids may help prevent toxicities from occurring. These same therapies may be used to treat symptoms after they have occurred. More severe cases with systemic symptoms or failure to improve with the above measures may need prednisone or cessation of therapy.

This patient was started on topical hydrocortisone 2.5% ointment twice daily and oral doxycycline 100 mg bid for 6 weeks. She had dramatic improvement within 3 weeks. Doxycycline was subsequently continued at a dose of 100 mg/d and the patient was able to continue with her chemotherapy combination for several more months. Unfortunately, her colon cancer progressed despite therapy and she ultimately died from cancer-related complications.

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

References

1. Bouché O, Ben Abdelghani M, Labourey JL, et al. Management of skin toxicities during panitumumab treatment in metastatic colorectal cancer. World J Gastroenterol. 2019;25:4007-4018. doi: 10.3748/wjg.v25.i29.4007

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A review of the patient’s chemotherapy medications revealed that 4 weeks earlier, panitumumab had been added to her folinic acid, fluorouracil, and irinotecan (FOLFIRI) regimen. The physician diagnosed this acneiform eruption as an adverse effect of the panitumumab.

Panitumumab is a monoclonal antibody that works to inhibit epidermal growth factor receptor (EGFR) proteins that are overexpressed on some solid tumors and responsible for cancer cell proliferation. EGFR inhibitor–induced acneiform eruptions are common in patients receiving panitumumab.

EGFR proteins have been a target of chemotherapy since the approval of the small molecule erlotinib in 2004. Panitumumab and cetuximab are monoclonal antibodies targeting EGFR and improve long-term survival in patients with metastatic colorectal cancer when added to other standard chemotherapy regimens. EGFR is found throughout the epidermis and all EGFR inhibitors may cause unique skin toxicity not seen with other chemotherapy agents. In 1 study of 229 patients, 59% of patients exhibited skin toxicity at Day 15; the most common examples included widespread acne-like papules and pustules or an eczema-like manifestation.1 Eruptions may be worsened by significant sun exposure while on panitumumab. In this case, the acneiform eruption occurred more intensely along visible facial telangiectasias.

When EGFR inhibitor–induced acneiform eruption occurs, patients commonly develop skin toxicity within the first 2 to 4 weeks of therapy. Pre-therapy doxycycline or minocycline and/or topical steroids may help prevent toxicities from occurring. These same therapies may be used to treat symptoms after they have occurred. More severe cases with systemic symptoms or failure to improve with the above measures may need prednisone or cessation of therapy.

This patient was started on topical hydrocortisone 2.5% ointment twice daily and oral doxycycline 100 mg bid for 6 weeks. She had dramatic improvement within 3 weeks. Doxycycline was subsequently continued at a dose of 100 mg/d and the patient was able to continue with her chemotherapy combination for several more months. Unfortunately, her colon cancer progressed despite therapy and she ultimately died from cancer-related complications.

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Pustules on face

A review of the patient’s chemotherapy medications revealed that 4 weeks earlier, panitumumab had been added to her folinic acid, fluorouracil, and irinotecan (FOLFIRI) regimen. The physician diagnosed this acneiform eruption as an adverse effect of the panitumumab.

Panitumumab is a monoclonal antibody that works to inhibit epidermal growth factor receptor (EGFR) proteins that are overexpressed on some solid tumors and responsible for cancer cell proliferation. EGFR inhibitor–induced acneiform eruptions are common in patients receiving panitumumab.

EGFR proteins have been a target of chemotherapy since the approval of the small molecule erlotinib in 2004. Panitumumab and cetuximab are monoclonal antibodies targeting EGFR and improve long-term survival in patients with metastatic colorectal cancer when added to other standard chemotherapy regimens. EGFR is found throughout the epidermis and all EGFR inhibitors may cause unique skin toxicity not seen with other chemotherapy agents. In 1 study of 229 patients, 59% of patients exhibited skin toxicity at Day 15; the most common examples included widespread acne-like papules and pustules or an eczema-like manifestation.1 Eruptions may be worsened by significant sun exposure while on panitumumab. In this case, the acneiform eruption occurred more intensely along visible facial telangiectasias.

When EGFR inhibitor–induced acneiform eruption occurs, patients commonly develop skin toxicity within the first 2 to 4 weeks of therapy. Pre-therapy doxycycline or minocycline and/or topical steroids may help prevent toxicities from occurring. These same therapies may be used to treat symptoms after they have occurred. More severe cases with systemic symptoms or failure to improve with the above measures may need prednisone or cessation of therapy.

This patient was started on topical hydrocortisone 2.5% ointment twice daily and oral doxycycline 100 mg bid for 6 weeks. She had dramatic improvement within 3 weeks. Doxycycline was subsequently continued at a dose of 100 mg/d and the patient was able to continue with her chemotherapy combination for several more months. Unfortunately, her colon cancer progressed despite therapy and she ultimately died from cancer-related complications.

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

References

1. Bouché O, Ben Abdelghani M, Labourey JL, et al. Management of skin toxicities during panitumumab treatment in metastatic colorectal cancer. World J Gastroenterol. 2019;25:4007-4018. doi: 10.3748/wjg.v25.i29.4007

References

1. Bouché O, Ben Abdelghani M, Labourey JL, et al. Management of skin toxicities during panitumumab treatment in metastatic colorectal cancer. World J Gastroenterol. 2019;25:4007-4018. doi: 10.3748/wjg.v25.i29.4007

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Lose weight, gain huge debt: N.Y. provider has sued more than 300 patients who had bariatric surgery

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Wed, 05/03/2023 - 09:29

 

Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay,
KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

  • A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
  • A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
  • A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Topics
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Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay,
KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

  • A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
  • A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
  • A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 

Seven months after Lahavah Wallace’s weight-loss operation, a New York bariatric surgery practice sued her, accusing her of “intentionally” failing to pay nearly $18,000 of her bill.

Long Island Minimally Invasive Surgery, which does business as the New York Bariatric Group, went on to accuse Ms. Wallace of “embezzlement,” alleging she kept insurance payments that should have been turned over to the practice.

Ms. Wallace denies the allegations, which the bariatric practice has leveled against patients in hundreds of debt-collection lawsuits filed over the past 4 years, court records in New York state show.

In about 60 cases, the lawsuits demanded $100,000 or more from patients. Some patients were found liable for tens of thousands of dollars in interest charges or wound up shackled with debt that could take a decade or more to shake. Others are facing the likely prospect of six-figure financial penalties, court records show.

Backed by a major private equity firm, the bariatric practice spends millions each year on advertisements featuring patients who have dropped 100 pounds or more after bariatric procedures, sometimes having had a portion of their stomachs removed. The ads have run on TV, online, and on New York City subway posters.

The online ads, often showcasing the slogan “Stop obesity for life,” appealed to Ms. Wallace, who lives in Brooklyn and works as a legal assistant for the state of New York. She said she turned over checks from her insurer to the bariatric group and was stunned when the medical practice hauled her into court citing an “out-of-network payment agreement” she had signed before her surgery.

“I really didn’t know what I was signing,” Ms. Wallace told KFF Health News. “I didn’t pay enough attention.”

Shawn Garber, MD, a bariatric surgeon who founded the practice in 2000 on Long Island and serves as its CEO, said that “prior to rendering services” his office staff advises patients of the costs and their responsibility to pay the bill.

The bariatric group has cited these out-of-network payment agreements in at least 300 lawsuits filed against patients from January 2019 to 2022 demanding nearly $19 million to cover medical bills, interest charges, and attorney’s fees, a KFF Health News review of New York state court records found.

Danny De Voe, a partner at Sahn Ward Braff Koblenz law firm in Uniondale, N.Y., who filed many of those suits, declined to comment, citing attorney-client privilege.

In most cases, the medical practice had agreed to accept an insurance company’s out-of-network rate as full payment for its services – with caveats, according to court filings.

In the agreements they signed, patients promised to pay any coinsurance, meeting any deductible, and pass on to the medical practice any reimbursement checks they received from their health plans within 7 days.

Patients who fail to do so “will be held responsible for the full amount charged for your surgery, plus the cost of legal fees,” the agreement states.

That “full amount” can be thousands of dollars higher than what insurers would likely pay,
KFF Health News found – while legal fees and other costs can layer on thousands more.

Elisabeth Benjamin, a lawyer with the Community Service Society of New York, said conflicts can arise when insurers send checks to pay for out-of-network medical services to patients rather than reimbursing a medical provider directly.

“We would prefer to see regulators step in and stop that practice,” she said, adding it “causes tension between providers and patients.”

That’s certainly true for Ms. Wallace. The surgery practice sued her in August 2022demanding $17,981 in fees it said remained unpaid after her January 2022 laparoscopic sleeve gastrectomy, an operation in which much of the stomach is removed to assist weight loss.

The lawsuit also tacked on a demand for $5,993 in attorney’s fees, court records show.

The suit alleges Ms. Wallace signed the contract even though she “had no intention” of paying her bills. The complaint goes on to accuse her of “committing embezzlement” by “willfully, intentionally, deliberately and maliciously” depositing checks from her health plan into her personal account.

The suit doesn’t include details to substantiate these claims, and Ms. Wallace said in her court response they are not true. Ms. Wallace said she turned over checks for the charges.

“They billed the insurance for everything they possibly could,” Ms. Wallace said.

In September, Ms. Wallace filed for bankruptcy, hoping to discharge the bariatric care debt along with about $4,700 in unrelated credit card charges.

The medical practice fired back in November by filing an “adversary complaint” in her Brooklyn bankruptcy court proceeding that argues her medical debt should not be forgiven because Ms. Wallace committed fraud.

The adversary complaint, which is pending in the bankruptcy case, accuses Ms. Wallace of “fraudulently” inducing the surgery center to perform “elective medical procedures” without requiring payment up front.

Both the harsh wording and claims of wrongdoing have infuriated Ms. Wallace and her attorney, Jacob Silver, of Brooklyn.

Mr. Silver wants the medical practice to turn over records of the payments received from Ms. Wallace. “There is no fraud here,” he said. “This is frivolous. We are taking a no-settlement position.”
 

Gaining debt

Few patients sued by the bariatric practice mount a defense in court and those who do fight often lose, court records show.

The medical practice won default judgments totaling nearly $6 million in about 90 of the 300 cases in the sample reviewed by KFF Health News. Default judgments are entered when the defendant fails to respond.

Many cases either are pending, or it is not clear from court filings how they were resolved.

Some patients tried to argue that the fees were too high or that they didn’t understand going in how much they could owe. One woman, trying to push back against a demand for more than $100,000, said in a legal filing that she “was given numerous papers to sign without anyone of the staff members explaining to me what it actually meant.” Another patient, who was sued for more than $40,000, wrote: “I don’t have the means to pay this bill.”

Among the cases described in court records:

  • A Westchester County, N.Y., woman was sued for $102,556 and settled for $72,000 in May 2021. She agreed to pay $7,500 upon signing the settlement and $500 a month from September 2021 to May 2032.
  • A Peekskill, N.Y., woman in a December 2019 judgment was held liable for $384,092, which included $94,047 in interest.
  • A Newburgh, N.Y., man was sued in 2021 for $252,309 in medical bills, 12% interest, and $84,103 in attorneys’ fees. The case is pending.

Robert Cohen, a longtime attorney for the bariatric practice, testified in a November 2021 hearing that the lawyers take “a contingency fee of one-third of our recovery” in these cases. In that case, Mr. Cohen had requested $13,578 based on his contingency fee arrangement. He testified that he spent 7.3 hours on the case and that his customary billing rate was $475 per hour, which came to $3,467.50. The judge awarded the lower amount, according to a transcript of the hearing.

Teresa LaMasters, MD, president of the American Society for Metabolic and Bariatric Surgery, said suing patients for large sums “is not a common practice” among bariatric surgeons.

“This is not what the vast majority in the field would espouse,” she said.

But Dr. Garber, the NYBG’s chief executive, suggested patients deserve blame.

“These lawsuits stem from these patients stealing the insurance money rather than forwarding it onto NYBG as they are morally and contractually obligated to do,” Dr. Garber wrote in an email to KFF Health News.

Dr. Garber added: “The issue is not with what we bill, but rather with the fact that the insurance companies refuse to send payment directly to us.”
 

‘A kooky system’

Defense attorneys argue that many patients don’t fully comprehend the perils of failing to pay on time – for whatever reason.

In a few cases, patients admitted pocketing checks they were obligated to turn over to the medical practice. But for the most part, court records don’t specify how many such checks were issued and for what amounts – or whether the patient improperly cashed them.

“It’s a kooky system,” said Paul Brite, an attorney who has faced off against the bariatric practice in court.

“You sign these documents that could cost you tons of money. It shouldn’t be that way,” he said. “This can ruin their financial life.”

New York lawmakers have acted to limit the damage from medical debt, including “surprise bills.”

In November, Democratic Gov. Kathy Hochul signed legislation that prohibits health care providers from slapping liens on a primary residence or garnishing wages.

But contracts with onerous repayment terms represent an “evolving area of law” and an alarming “new twist” on concerns over medical debt, said Ms. Benjamin, the community service society lawyer.

She said contract “accelerator clauses” that trigger severe penalties if patients miss payments should not be permitted for medical debt.

“If you default, the full amount is due,” she said. “This is really a bummer.”
 

‘Fair market value’

The debt collection lawsuits argue that weight-loss patients had agreed to pay “fair market value” for services – and the doctors are only trying to secure money they are due.

But some prices far exceed typical insurance payments for obesity treatments across the country, according to a medical billing data registry. Surgeons performed about 200,000 bariatric operations in 2020, according to the bariatric surgery society.

Ms. Wallace, the Brooklyn legal assistant, was billed $60,500 for her lap sleeve gastrectomy, though how much her insurance actually paid remains to be hashed out in court.

Michael Arrigo, a California medical billing expert at No World Borders, called the prices “outrageous” and “unreasonable and, in fact, likely unconscionable.”

“I disagree that these are fair market charges,” he said.

Dr. LaMasters called the gastrectomy price billed to Ms. Wallace “really expensive” and “a severe outlier.” While charges vary by region, she quoted a typical price of around $22,000.

Dr. Garber said NYBG “bills at usual and customary rates” determined by Fair Health, a New York City-based repository of insurance claims data. Fair Health “sets these rates based upon the acceptable price for our geographic location,” he said.

But Rachel Kent, Fair Health’s senior director of marketing, told KFF Health News that the group “does not set rates, nor determine or take any position on what constitutes ‘usual and customary rates.’ ” Instead, it reports the prices providers are charging in a given area.

Overall, Fair Health data shows huge price variations even in adjacent ZIP codes in the metro area. In Long Island’s Roslyn Heights neighborhood, where NYBG is based, Fair Health lists the out-of-network price charged by providers in the area as $60,500, the figure Ms. Wallace was billed.

But in several other New York City–area ZIP codes the price charged for the gastrectomy procedure hovers around $20,000, according to the data bank. The price in Manhattan is $17,500, for instance, according to Fair Health.

Nationwide, the average cost in 2021 for bariatric surgery done in a hospital was $32,868, according to a KFF analysis of health insurance claims.
 

Private equity arrives

Dr. Garber said in a court affidavit in May 2022 that he founded the bariatric practice “with a singular focus: providing safe, effective care to patients suffering from obesity and its resulting complications.”

Under his leadership, the practice has “developed into New York’s elite institution for obesity treatment,” Dr. Garber said. He said the group’s surgeons are “highly sought after to train other bariatric surgeons throughout the country and are active in the development of new, cutting-edge bariatric surgery techniques.”

In 2017, Dr. Garber and partners agreed on a business plan to help spur growth and “attract private equity investment,” according to the affidavit.

They formed a separate company to handle the bariatric practice’s business side. Known as management services organizations, such companies provide a way for private equity investors to circumvent laws in some states that prohibit nonphysicians from owning a stake in a medical practice.

In August 2019, the private equity firm Sentinel Capital Partners bought 65% of the MSO for $156.5 million, according to Dr. Garber’s affidavit. The management company is now known as New You Bariatric Group. The private equity firm did not respond to requests for comment.

Dr. Garber, in a September 2021 American Society for Metabolic and Bariatric Surgery webinar viewable online, said the weight-loss practice spends $6 million a year on media and marketing directly to patients – and is on a roll. Nationally, bariatric surgery is growing 6% annually, he said. NYBG boasts two dozen offices in the tri-state area of New York, New Jersey, and Connecticut and is poised to expand into more states.

“Since private equity, we’ve been growing at 30%-40% year over year,” Dr. Garber said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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