Clinician Reviews

The arrival of GLP-1 receptor agonists has revolutionized treatment options for people with obesity and medical practice.

This news organization recently hosted a panel of experts across specialties — including endocrinology, gastroenterology, and obesity medicine — to discuss these potentially life-changing medications and to answer questions from the audience.

Because of the flood of queries from our audience, we asked our panelists to address some of the questions that didn’t make the recording. Their answers are below.

Beverly Tchang, MD, endocrinologist, Weill Cornell Medicine, New York City

Audience member: Can you initiate glucagon-like peptide-1 agonists (GLP-1 RAs) as a primary drug in a patient with obesity and newly diagnosed type 2 diabetes?

BT: We often prescribe GLP-1 RAs to individuals with type 2 diabetes as a first-line medication. Guidelines from the American Diabetes Association are really emphasizing a patient-centered approach, and metformin may not be the best first-line medication anymore.

Audience member: What should clinicians know about dose titration of GLP-1 RAs in diabetic patients with renal disease, especially those in stages IV and V chronic kidney disease?

BT: GLP-1 RAs do not need to be renally dosed, but I still recommend conferring with the patient’s nephrologist because the glomerular filtration rate might decrease in the setting of dehydration. Because GLP1s suppress the thirst, not just appetite, patients can go all day without drinking water and not feel thirsty.

Michael Camilleri, MD, gastroenterologist, Mayo Clinic, Rochester, Minnesota

Audience member: Should GLP-1 RAs be held for 1 week or 4 weeks prior to surgery to reduce the patient’s risk for aspiration? And is tapering required?

MC: For a patient taking liraglutide, I would hold the drug for 1 week prior to surgery. For patients taking other GLP-1 RAs, including extended exenatide, I advise holding for between 2 and 3 weeks before the procedure. It’s also important to make sure the patient’s diabetes is well-controlled with other medications — not GLP-1 RAs — during this period.

After surgery, you can restart GLP-1 RA therapy once there is recovery of oral food intake and normal bowel function.

Audience member: Is treatment with GLP-1 RAs appropriate for a patient with a family history of colon cancer but an otherwise unremarkable medical and family history?

MC: I have not seen a contraindication to receiving GLP-1 RAs based on a family history of colorectal cancer or other malignancies. An analysis of the French national healthcare insurance system database has suggested 1-3 years use of GLP-1 RAs (exenatide, liraglutide, and dulaglutide) may be linked with increased occurrence of thyroid cancer. Data from 37 randomized controlled trials and 19 real-world studies having 16,839 patients in placebo control group, 16,550 patients in active control group, and 13,330 patients in real-world studies were analyzed in a 2023 systematic review and meta-analysis. Compared to placebo or active control treatments, occurrence of pancreatic cancer, thyroid cancer, and all neoplasms — benign, malignant, and otherwise unspecified — were similar in the semaglutide group.

Toshi Iroku-Malize, MD, MPH, MBA, FAAFP, family physician, Zucker School of Medicine, Hempstead, New York

Audience member: What do you do about elevated liver functions after starting treatment with GLP-1 RAs, and what do you do when a patient has reached their weight loss goal?

TI-M: I recommend monitoring the liver function tests, evaluating for underlying causes, such as viral hepatitis, alcohol-related damage, or problems with other medications, and consulting a gastroenterologist or liver specialist if necessary. It’s also important to discuss the risk-benefit of continuing on the GP-1 RA for that particular patient.

Audience member: What effects will GLP-1 RAs have on sleep-disordered breathing/obstructive sleep apnea (OSA)? Are you aware of any ongoing trials addressing this subject?

TI-M: GLP-1 RAs may have beneficial effects on sleep-disordered breathing and OSA through weight loss, which can lead to a reduction in excess adipose tissue, and improvements in metabolic parameters. In terms of studies, a 2023 paper addressed this question, but more research is needed.

Audience member: Is it within a psychiatric provider’s scope of practice to prescribe GLP-1 agents for the reduction of weight gain associated with psychiatric medications?

TI-M: Obesity medicine is an interdisciplinary process. Numerous medications prescribed for mental health can contribute to obesity, and psychiatrists can play a role in collaborating with a patient’s primary care provider and/or obesity medicine specialist to determine which medications can be adjusted or replaced. It is important to remember that obesity management is not just about medications. It requires managing nutrition and activity in addition to behavioral health issues and social determinants of health. If the clinician has had the training to manage these pillars and is comfortable managing this chronic illness — similar to diabetes, hypertension, and other conditions — then this is a possibility. Otherwise, team-based care is appropriate.

Holly Lofton, MD, obesity medicine, NYU Langone Health, New York City

Audience member: Can we safely use them on patients who have had bariatric surgery and regularly develop dumping syndrome?

HL: These medications can be used after bariatric surgery in patients who meet the criteria for pharmacologic treatment. If a patient is having postoperative symptoms of dumping syndrome or excessive gastrointestinal losses from vomiting or diarrhea, dietary adjustments and other methods of managing the dumping syndrome in gastric bypass patients should be initiated before considering GLP-1 RAs because these patients do not have a functioning pylorus in their alimentary tract and these drugs are not indicated to treat dumping syndrome. The first-line approach typically involves reducing the patient’s intake of simple carbohydrates but can also include medications or surgical intervention when appropriate.

Audience member: Would teaching a patient to fast intermittently while they’re on GLP-1 RAs help them preserve weight loss if they choose to wean off the medication?

HL: Personally, I feel it is best to use the titration period and the time in which the patient is actively losing weight when on GLP-1 RAs. These are the best periods to help develop an individualized treatment plan, one that includes nutrition, activity, behavior modification, and resistance training. The patient’s lifestyle plan will likely change based on their environment and other factors. Intermittent fasting can be a part of such a plan. There is no consensus as to exactly which eating pattern will help patients maintain weight once they lose the physiologic benefit of the weight loss medications. However, studies have been published that demonstrate an average weight regain of 66% or greater when patients go from taking the maximum dose of a GLP-1 RA to taking none at all. Thus, patients should still be followed closely for weight regain when they discontinue a GLP-1 RA.

A version of this article appeared on Medscape.com.

The arrival of GLP-1 receptor agonists has revolutionized treatment options for people with obesity and medical practice.

This news organization recently hosted a panel of experts across specialties — including endocrinology, gastroenterology, and obesity medicine — to discuss these potentially life-changing medications and to answer questions from the audience.

Because of the flood of queries from our audience, we asked our panelists to address some of the questions that didn’t make the recording. Their answers are below.

Beverly Tchang, MD, endocrinologist, Weill Cornell Medicine, New York City

Audience member: Can you initiate glucagon-like peptide-1 agonists (GLP-1 RAs) as a primary drug in a patient with obesity and newly diagnosed type 2 diabetes?

BT: We often prescribe GLP-1 RAs to individuals with type 2 diabetes as a first-line medication. Guidelines from the American Diabetes Association are really emphasizing a patient-centered approach, and metformin may not be the best first-line medication anymore.

Audience member: What should clinicians know about dose titration of GLP-1 RAs in diabetic patients with renal disease, especially those in stages IV and V chronic kidney disease?

BT: GLP-1 RAs do not need to be renally dosed, but I still recommend conferring with the patient’s nephrologist because the glomerular filtration rate might decrease in the setting of dehydration. Because GLP1s suppress the thirst, not just appetite, patients can go all day without drinking water and not feel thirsty.

Michael Camilleri, MD, gastroenterologist, Mayo Clinic, Rochester, Minnesota

Audience member: Should GLP-1 RAs be held for 1 week or 4 weeks prior to surgery to reduce the patient’s risk for aspiration? And is tapering required?

MC: For a patient taking liraglutide, I would hold the drug for 1 week prior to surgery. For patients taking other GLP-1 RAs, including extended exenatide, I advise holding for between 2 and 3 weeks before the procedure. It’s also important to make sure the patient’s diabetes is well-controlled with other medications — not GLP-1 RAs — during this period.

After surgery, you can restart GLP-1 RA therapy once there is recovery of oral food intake and normal bowel function.

Audience member: Is treatment with GLP-1 RAs appropriate for a patient with a family history of colon cancer but an otherwise unremarkable medical and family history?

MC: I have not seen a contraindication to receiving GLP-1 RAs based on a family history of colorectal cancer or other malignancies. An analysis of the French national healthcare insurance system database has suggested 1-3 years use of GLP-1 RAs (exenatide, liraglutide, and dulaglutide) may be linked with increased occurrence of thyroid cancer. Data from 37 randomized controlled trials and 19 real-world studies having 16,839 patients in placebo control group, 16,550 patients in active control group, and 13,330 patients in real-world studies were analyzed in a 2023 systematic review and meta-analysis. Compared to placebo or active control treatments, occurrence of pancreatic cancer, thyroid cancer, and all neoplasms — benign, malignant, and otherwise unspecified — were similar in the semaglutide group.

Toshi Iroku-Malize, MD, MPH, MBA, FAAFP, family physician, Zucker School of Medicine, Hempstead, New York

Audience member: What do you do about elevated liver functions after starting treatment with GLP-1 RAs, and what do you do when a patient has reached their weight loss goal?

TI-M: I recommend monitoring the liver function tests, evaluating for underlying causes, such as viral hepatitis, alcohol-related damage, or problems with other medications, and consulting a gastroenterologist or liver specialist if necessary. It’s also important to discuss the risk-benefit of continuing on the GP-1 RA for that particular patient.

Audience member: What effects will GLP-1 RAs have on sleep-disordered breathing/obstructive sleep apnea (OSA)? Are you aware of any ongoing trials addressing this subject?

TI-M: GLP-1 RAs may have beneficial effects on sleep-disordered breathing and OSA through weight loss, which can lead to a reduction in excess adipose tissue, and improvements in metabolic parameters. In terms of studies, a 2023 paper addressed this question, but more research is needed.

Audience member: Is it within a psychiatric provider’s scope of practice to prescribe GLP-1 agents for the reduction of weight gain associated with psychiatric medications?

TI-M: Obesity medicine is an interdisciplinary process. Numerous medications prescribed for mental health can contribute to obesity, and psychiatrists can play a role in collaborating with a patient’s primary care provider and/or obesity medicine specialist to determine which medications can be adjusted or replaced. It is important to remember that obesity management is not just about medications. It requires managing nutrition and activity in addition to behavioral health issues and social determinants of health. If the clinician has had the training to manage these pillars and is comfortable managing this chronic illness — similar to diabetes, hypertension, and other conditions — then this is a possibility. Otherwise, team-based care is appropriate.

Holly Lofton, MD, obesity medicine, NYU Langone Health, New York City

Audience member: Can we safely use them on patients who have had bariatric surgery and regularly develop dumping syndrome?

HL: These medications can be used after bariatric surgery in patients who meet the criteria for pharmacologic treatment. If a patient is having postoperative symptoms of dumping syndrome or excessive gastrointestinal losses from vomiting or diarrhea, dietary adjustments and other methods of managing the dumping syndrome in gastric bypass patients should be initiated before considering GLP-1 RAs because these patients do not have a functioning pylorus in their alimentary tract and these drugs are not indicated to treat dumping syndrome. The first-line approach typically involves reducing the patient’s intake of simple carbohydrates but can also include medications or surgical intervention when appropriate.

Audience member: Would teaching a patient to fast intermittently while they’re on GLP-1 RAs help them preserve weight loss if they choose to wean off the medication?

HL: Personally, I feel it is best to use the titration period and the time in which the patient is actively losing weight when on GLP-1 RAs. These are the best periods to help develop an individualized treatment plan, one that includes nutrition, activity, behavior modification, and resistance training. The patient’s lifestyle plan will likely change based on their environment and other factors. Intermittent fasting can be a part of such a plan. There is no consensus as to exactly which eating pattern will help patients maintain weight once they lose the physiologic benefit of the weight loss medications. However, studies have been published that demonstrate an average weight regain of 66% or greater when patients go from taking the maximum dose of a GLP-1 RA to taking none at all. Thus, patients should still be followed closely for weight regain when they discontinue a GLP-1 RA.

A version of this article appeared on Medscape.com.

The arrival of GLP-1 receptor agonists has revolutionized treatment options for people with obesity and medical practice.

This news organization recently hosted a panel of experts across specialties — including endocrinology, gastroenterology, and obesity medicine — to discuss these potentially life-changing medications and to answer questions from the audience.

Because of the flood of queries from our audience, we asked our panelists to address some of the questions that didn’t make the recording. Their answers are below.

Beverly Tchang, MD, endocrinologist, Weill Cornell Medicine, New York City

Audience member: Can you initiate glucagon-like peptide-1 agonists (GLP-1 RAs) as a primary drug in a patient with obesity and newly diagnosed type 2 diabetes?

BT: We often prescribe GLP-1 RAs to individuals with type 2 diabetes as a first-line medication. Guidelines from the American Diabetes Association are really emphasizing a patient-centered approach, and metformin may not be the best first-line medication anymore.

Audience member: What should clinicians know about dose titration of GLP-1 RAs in diabetic patients with renal disease, especially those in stages IV and V chronic kidney disease?

BT: GLP-1 RAs do not need to be renally dosed, but I still recommend conferring with the patient’s nephrologist because the glomerular filtration rate might decrease in the setting of dehydration. Because GLP1s suppress the thirst, not just appetite, patients can go all day without drinking water and not feel thirsty.

Michael Camilleri, MD, gastroenterologist, Mayo Clinic, Rochester, Minnesota

Audience member: Should GLP-1 RAs be held for 1 week or 4 weeks prior to surgery to reduce the patient’s risk for aspiration? And is tapering required?

MC: For a patient taking liraglutide, I would hold the drug for 1 week prior to surgery. For patients taking other GLP-1 RAs, including extended exenatide, I advise holding for between 2 and 3 weeks before the procedure. It’s also important to make sure the patient’s diabetes is well-controlled with other medications — not GLP-1 RAs — during this period.

After surgery, you can restart GLP-1 RA therapy once there is recovery of oral food intake and normal bowel function.

Audience member: Is treatment with GLP-1 RAs appropriate for a patient with a family history of colon cancer but an otherwise unremarkable medical and family history?

MC: I have not seen a contraindication to receiving GLP-1 RAs based on a family history of colorectal cancer or other malignancies. An analysis of the French national healthcare insurance system database has suggested 1-3 years use of GLP-1 RAs (exenatide, liraglutide, and dulaglutide) may be linked with increased occurrence of thyroid cancer. Data from 37 randomized controlled trials and 19 real-world studies having 16,839 patients in placebo control group, 16,550 patients in active control group, and 13,330 patients in real-world studies were analyzed in a 2023 systematic review and meta-analysis. Compared to placebo or active control treatments, occurrence of pancreatic cancer, thyroid cancer, and all neoplasms — benign, malignant, and otherwise unspecified — were similar in the semaglutide group.

Toshi Iroku-Malize, MD, MPH, MBA, FAAFP, family physician, Zucker School of Medicine, Hempstead, New York

Audience member: What do you do about elevated liver functions after starting treatment with GLP-1 RAs, and what do you do when a patient has reached their weight loss goal?

TI-M: I recommend monitoring the liver function tests, evaluating for underlying causes, such as viral hepatitis, alcohol-related damage, or problems with other medications, and consulting a gastroenterologist or liver specialist if necessary. It’s also important to discuss the risk-benefit of continuing on the GP-1 RA for that particular patient.

Audience member: What effects will GLP-1 RAs have on sleep-disordered breathing/obstructive sleep apnea (OSA)? Are you aware of any ongoing trials addressing this subject?

TI-M: GLP-1 RAs may have beneficial effects on sleep-disordered breathing and OSA through weight loss, which can lead to a reduction in excess adipose tissue, and improvements in metabolic parameters. In terms of studies, a 2023 paper addressed this question, but more research is needed.

Audience member: Is it within a psychiatric provider’s scope of practice to prescribe GLP-1 agents for the reduction of weight gain associated with psychiatric medications?

TI-M: Obesity medicine is an interdisciplinary process. Numerous medications prescribed for mental health can contribute to obesity, and psychiatrists can play a role in collaborating with a patient’s primary care provider and/or obesity medicine specialist to determine which medications can be adjusted or replaced. It is important to remember that obesity management is not just about medications. It requires managing nutrition and activity in addition to behavioral health issues and social determinants of health. If the clinician has had the training to manage these pillars and is comfortable managing this chronic illness — similar to diabetes, hypertension, and other conditions — then this is a possibility. Otherwise, team-based care is appropriate.

Holly Lofton, MD, obesity medicine, NYU Langone Health, New York City

Audience member: Can we safely use them on patients who have had bariatric surgery and regularly develop dumping syndrome?

HL: These medications can be used after bariatric surgery in patients who meet the criteria for pharmacologic treatment. If a patient is having postoperative symptoms of dumping syndrome or excessive gastrointestinal losses from vomiting or diarrhea, dietary adjustments and other methods of managing the dumping syndrome in gastric bypass patients should be initiated before considering GLP-1 RAs because these patients do not have a functioning pylorus in their alimentary tract and these drugs are not indicated to treat dumping syndrome. The first-line approach typically involves reducing the patient’s intake of simple carbohydrates but can also include medications or surgical intervention when appropriate.

Audience member: Would teaching a patient to fast intermittently while they’re on GLP-1 RAs help them preserve weight loss if they choose to wean off the medication?

HL: Personally, I feel it is best to use the titration period and the time in which the patient is actively losing weight when on GLP-1 RAs. These are the best periods to help develop an individualized treatment plan, one that includes nutrition, activity, behavior modification, and resistance training. The patient’s lifestyle plan will likely change based on their environment and other factors. Intermittent fasting can be a part of such a plan. There is no consensus as to exactly which eating pattern will help patients maintain weight once they lose the physiologic benefit of the weight loss medications. However, studies have been published that demonstrate an average weight regain of 66% or greater when patients go from taking the maximum dose of a GLP-1 RA to taking none at all. Thus, patients should still be followed closely for weight regain when they discontinue a GLP-1 RA.

A version of this article appeared on Medscape.com.

Women with polycystic ovary syndrome (PCOS) may be as much as eight times more likely to attempt suicide than are those without the disorder, according to a new study published in the Annals of Internal Medicine on February 5.

The results point to the importance of mental health screening for all patients who may have syndrome, the researchers concluded.

“If we can know such conditions earlier in our clinical practice, we may reduce the subsequence risk and bad consequences,” said Mu-Hong Chen, MD, PhD, an attending psychiatrist at the Department of Psychiatry at Taipei Veterans General Hospital in Taiwan, a coauthor of the study. 

PCOS affects as many as 15% of reproductive-age women in the United States, or approximately six million people. The condition is associated with an increased risk for metabolic disorders, like diabetes and metabolic syndrome, and cardiovascular problems, like hypertension and stroke. The disorder is associated with infertility, weight gain, hirsutism, and skin changes. Evidence also shows that these changes can lead to poorer self-image and mental health conditions like depression and anxiety. 

Dr. Chen and his coauthors compared the records of nearly 19,000 women between ages 12 and 64 years who had a PCOS diagnosis with a matched control group of 189,600 women and girls without PCOS using data from 1997 to 2012 in the Taiwan National Health Insurance Research Database. Cohorts were matched by age, income, urbanization level, and mental health conditions.

The researchers found that the women diagnosed with PCOS were at an 8.47 times higher risk for suicide attempt over the 16-year follow-up period than were women without the condition. Older women with PCOS had slightly lower risk compared with younger women, but the risk was higher compared with older women without PCOS. Studies in other countries have shown similar results.

Adolescents with PCOS had more than five times the risk for attempted suicide than did the control group (hazard ratio [HR], 5.38; 95% CI, 3.93-7.3). Those between ages 20 and 40 years had more than nine times the risk for attempted suicide (HR, 9.15; 95% CI, 8.03-10.42), and those older than 40 years had the lowest risk (HR, 3.75; 95% CI, 2.23-6.28). 

The number of women with PCOS in the study was likely underreported, and those who were included likely had more serious cases, according to Ricardo Azziz, MD, MPH, MBA, professor in the Department of Obstetrics & Gynecology and the Department of Medicine at the University of Alabama at Birmingham. 

The findings, “speak to the fact that women with PCOS do have a greater incidence of mental health disorders and do require clinicians and patients themselves and their families to be aware of these risks,” said Dr. Azziz, former CEO of the American Society for Reproductive Medicine. 

Clinicians should ask their patients with PCOS about suicide risk and mental health, according to Dr. Azziz. 

“It’s not infrequent that those of us in clinical practice see patients who are significantly depressed, and we need to ask the right questions,” he said.

Though he was only aware of a few patients with PCOS who have attempted suicide, he said that clinicians should be prepared to refer these patients to another professional who can address mental health concerns if they express any signs of distress. 

“Simply asking and inviting patients to speak about this will allow physicians to identify patients who may need to be referred,” Dr. Azziz said. 

The study was funded by grants from the Taipei Veterans General Hospital, Yen Tjing Ling Medical Foundation, and the Ministry of Science and Technology of Taiwan. 

The study authors report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Women with polycystic ovary syndrome (PCOS) may be as much as eight times more likely to attempt suicide than are those without the disorder, according to a new study published in the Annals of Internal Medicine on February 5.

The results point to the importance of mental health screening for all patients who may have syndrome, the researchers concluded.

“If we can know such conditions earlier in our clinical practice, we may reduce the subsequence risk and bad consequences,” said Mu-Hong Chen, MD, PhD, an attending psychiatrist at the Department of Psychiatry at Taipei Veterans General Hospital in Taiwan, a coauthor of the study. 

PCOS affects as many as 15% of reproductive-age women in the United States, or approximately six million people. The condition is associated with an increased risk for metabolic disorders, like diabetes and metabolic syndrome, and cardiovascular problems, like hypertension and stroke. The disorder is associated with infertility, weight gain, hirsutism, and skin changes. Evidence also shows that these changes can lead to poorer self-image and mental health conditions like depression and anxiety. 

Dr. Chen and his coauthors compared the records of nearly 19,000 women between ages 12 and 64 years who had a PCOS diagnosis with a matched control group of 189,600 women and girls without PCOS using data from 1997 to 2012 in the Taiwan National Health Insurance Research Database. Cohorts were matched by age, income, urbanization level, and mental health conditions.

The researchers found that the women diagnosed with PCOS were at an 8.47 times higher risk for suicide attempt over the 16-year follow-up period than were women without the condition. Older women with PCOS had slightly lower risk compared with younger women, but the risk was higher compared with older women without PCOS. Studies in other countries have shown similar results.

Adolescents with PCOS had more than five times the risk for attempted suicide than did the control group (hazard ratio [HR], 5.38; 95% CI, 3.93-7.3). Those between ages 20 and 40 years had more than nine times the risk for attempted suicide (HR, 9.15; 95% CI, 8.03-10.42), and those older than 40 years had the lowest risk (HR, 3.75; 95% CI, 2.23-6.28). 

The number of women with PCOS in the study was likely underreported, and those who were included likely had more serious cases, according to Ricardo Azziz, MD, MPH, MBA, professor in the Department of Obstetrics & Gynecology and the Department of Medicine at the University of Alabama at Birmingham. 

The findings, “speak to the fact that women with PCOS do have a greater incidence of mental health disorders and do require clinicians and patients themselves and their families to be aware of these risks,” said Dr. Azziz, former CEO of the American Society for Reproductive Medicine. 

Clinicians should ask their patients with PCOS about suicide risk and mental health, according to Dr. Azziz. 

“It’s not infrequent that those of us in clinical practice see patients who are significantly depressed, and we need to ask the right questions,” he said.

Though he was only aware of a few patients with PCOS who have attempted suicide, he said that clinicians should be prepared to refer these patients to another professional who can address mental health concerns if they express any signs of distress. 

“Simply asking and inviting patients to speak about this will allow physicians to identify patients who may need to be referred,” Dr. Azziz said. 

The study was funded by grants from the Taipei Veterans General Hospital, Yen Tjing Ling Medical Foundation, and the Ministry of Science and Technology of Taiwan. 

The study authors report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Women with polycystic ovary syndrome (PCOS) may be as much as eight times more likely to attempt suicide than are those without the disorder, according to a new study published in the Annals of Internal Medicine on February 5.

The results point to the importance of mental health screening for all patients who may have syndrome, the researchers concluded.

“If we can know such conditions earlier in our clinical practice, we may reduce the subsequence risk and bad consequences,” said Mu-Hong Chen, MD, PhD, an attending psychiatrist at the Department of Psychiatry at Taipei Veterans General Hospital in Taiwan, a coauthor of the study. 

PCOS affects as many as 15% of reproductive-age women in the United States, or approximately six million people. The condition is associated with an increased risk for metabolic disorders, like diabetes and metabolic syndrome, and cardiovascular problems, like hypertension and stroke. The disorder is associated with infertility, weight gain, hirsutism, and skin changes. Evidence also shows that these changes can lead to poorer self-image and mental health conditions like depression and anxiety. 

Dr. Chen and his coauthors compared the records of nearly 19,000 women between ages 12 and 64 years who had a PCOS diagnosis with a matched control group of 189,600 women and girls without PCOS using data from 1997 to 2012 in the Taiwan National Health Insurance Research Database. Cohorts were matched by age, income, urbanization level, and mental health conditions.

The researchers found that the women diagnosed with PCOS were at an 8.47 times higher risk for suicide attempt over the 16-year follow-up period than were women without the condition. Older women with PCOS had slightly lower risk compared with younger women, but the risk was higher compared with older women without PCOS. Studies in other countries have shown similar results.

Adolescents with PCOS had more than five times the risk for attempted suicide than did the control group (hazard ratio [HR], 5.38; 95% CI, 3.93-7.3). Those between ages 20 and 40 years had more than nine times the risk for attempted suicide (HR, 9.15; 95% CI, 8.03-10.42), and those older than 40 years had the lowest risk (HR, 3.75; 95% CI, 2.23-6.28). 

The number of women with PCOS in the study was likely underreported, and those who were included likely had more serious cases, according to Ricardo Azziz, MD, MPH, MBA, professor in the Department of Obstetrics & Gynecology and the Department of Medicine at the University of Alabama at Birmingham. 

The findings, “speak to the fact that women with PCOS do have a greater incidence of mental health disorders and do require clinicians and patients themselves and their families to be aware of these risks,” said Dr. Azziz, former CEO of the American Society for Reproductive Medicine. 

Clinicians should ask their patients with PCOS about suicide risk and mental health, according to Dr. Azziz. 

“It’s not infrequent that those of us in clinical practice see patients who are significantly depressed, and we need to ask the right questions,” he said.

Though he was only aware of a few patients with PCOS who have attempted suicide, he said that clinicians should be prepared to refer these patients to another professional who can address mental health concerns if they express any signs of distress. 

“Simply asking and inviting patients to speak about this will allow physicians to identify patients who may need to be referred,” Dr. Azziz said. 

The study was funded by grants from the Taipei Veterans General Hospital, Yen Tjing Ling Medical Foundation, and the Ministry of Science and Technology of Taiwan. 

The study authors report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Two years after the end of a randomized trial that showed a benefit of daily vitamin D and omega-3 fatty acid (n-3 FA) supplementation for reducing risk for autoimmune diseases, the salubrious effects of daily vitamin D appear to have waned after the supplement was discontinued, while the protection from n-3 lived on for at least 2 additional years.

As previously reported, the randomized VITAL, which was designed primarily to study the effects of vitamin D and n-3 supplementation on incident cancer and cardiovascular disease, also showed that 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of n-3 FA supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases.

Now, investigators Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston, Massachusetts, and colleagues reported that among 21,592 participants in VITAL who agreed to be followed for an additional 2 years after discontinuation, the protection against autoimmune diseases from daily vitamin D (cholecalciferol; 2000 IU/d) was no longer statistically significant, but the benefits of daily marine n-3 FAs (1 g/d as a fish-oil capsule containing 460 mg of eicosapentaenoic acid and 380 mg of docosahexaenoic acid) remained significant.

“VITAL observational extension results suggest that vitamin D supplementation should be given on a continuous basis for long-term prevention of [autoimmune diseases]. The beneficial effects of n-3 fatty acids, however, may be prolonged for at least 2 years after discontinuation,” they wrote in an article published in Arthritis & Rheumatology.

Dr. Costenbader told this news organization that the results of the observational extension study suggest that the benefits of vitamin D “wear off more quickly, and it should be continued for a longer period of time or indefinitely, rather than only for 5 years.”

In addition to the disparity in the duration of the protective effect, the investigators also saw differences in the effects across different autoimmune diseases.

“The protective effect of vitamin D seemed strongest for psoriasis, while for omega-3 fatty acids, the protective effects were strongest for rheumatoid arthritis and inflammatory bowel disease,” she said.
 

Mixed Effects

In an interview with this news organization, Janet Funk, MD, MS, vice chair of research in the Department of Medicine and professor in the School of Nutritional Science and Wellness at the University of Arizona, Tucson, Arizona, who was not involved in the study, saidthat the results suggest that while each supplement may offer protection against autoimmune diseases, the effects are inconsistent and may not apply to all patients.

“I think the VITAL extension results suggest that either supplement (or both together) may have benefits in reducing risk of autoimmune diseases, including possible persistent effects posttreatment, but that these effects are nuanced (ie, only in normal weight post-vitamin D treatment) and possibly not uniform across all autoimmune diseases (including possible adverse effects for some — eg, inverse association between prior omega-3 and psoriasis and tendency for increased autoimmune thyroid disease for vitamin D), although the study was not powered sufficiently to draw disease-specific conclusions,” she said.

In an editorial accompanying the study, rheumatologist Joel M. Kremer, MD, of Albany Medical College and the Corrona Research Foundation in Delray Beach, Florida, wrote that “[T]he studies by Dr. Costenbader, et al. have shed new light on the possibility that dietary supplements of n-3 FA [fatty acid] may prevent the onset of [autoimmune disease]. The sustained benefits they describe for as long as 2 years after the supplements are discontinued are consistent with the chronicity of FA species in cellular plasma membranes where they serve as substrates for a diverse array of salient metabolic and inflammatory pathways.”
 

VITAL Then

To test whether vitamin D or marine-derived long-chain n-3 FA supplementation could protect against autoimmune disease over time, Dr. Costenbader and colleagues piggybacked an ancillary study onto the VITAL trial, which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older and 13,085 women aged 55 and older. The study had a 2 × 2 factorial design, with patients randomly assigned to vitamin D 2000 IU/d or placebo and then further randomized to either 1 g/d n-3 FAs or placebo in both the vitamin D and placebo primary randomization arms.

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with a hazard ratio (HR) of 0.68 (P = .02) for incident autoimmune disease, n-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03). However, when probable incident autoimmune disease cases were included, the effect of n-3 became significant, with an HR of 0.82.
 

VITAL Now

In the current analysis, Dr. Costenbader and colleagues reported observational data on 21,592 VITAL participants, a sample representing 83.5% of those who were initially randomized, and 87.9% of those who were alive and could be contacted at the end of the study.

As in the initial trial, the investigators used annual questionnaires to assess incident autoimmune diseases during the randomized follow-up. Participants were asked about new-onset, doctor-diagnosed rheumatoid arthritis, polymyalgia rheumatica, psoriasis, autoimmune thyroid disease, and inflammatory bowel disease. Participants could also write in any other new autoimmune disease diagnoses.

There were 236 new cases of confirmed autoimmune disease that occurred since the initial publication of the trial results, as well as 65 probable cases identified during the median 5.3 years of the randomized portion, and 42 probable cases diagnosed during the 2-year observational phase.

The investigators found that after the 2-year observation period, 255 participants initially randomized to receive vitamin D had a newly developed confirmed autoimmune disease, compared with 259 of those initially randomized to a vitamin D placebo. This translated into a nonsignificant HR of 0.98.

Adding probable autoimmune cases to the confirmed cases made little difference, resulting in a nonsignificant adjusted HR of 0.95.

In contrast, there were 234 confirmed autoimmune disease cases among patients initially assigned to n-3, compared with 280 among patients randomized to the n-3 placebo, translating into a statistically significant HR of 0.83 for new-onset autoimmune disease with n-3.

Dr. Costenbader and colleagues acknowledged that the study was limited by the use of doses intended to prevent cancer or cardiovascular disease and that higher doses intended for high-risk or nutritionally deficient populations might reveal larger effects of supplementation. In addition, they noted the difficulty of identifying the timing and onset of incident disease, and that the small number of cases that occurred during the 2-year observational period precluded detailed analyses of individual autoimmune diseases.

The study was funded by grants from the National Institutes of Health. Dr. Costenbader, Dr. Funk, and Dr. Kremer reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Two years after the end of a randomized trial that showed a benefit of daily vitamin D and omega-3 fatty acid (n-3 FA) supplementation for reducing risk for autoimmune diseases, the salubrious effects of daily vitamin D appear to have waned after the supplement was discontinued, while the protection from n-3 lived on for at least 2 additional years.

As previously reported, the randomized VITAL, which was designed primarily to study the effects of vitamin D and n-3 supplementation on incident cancer and cardiovascular disease, also showed that 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of n-3 FA supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases.

Now, investigators Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston, Massachusetts, and colleagues reported that among 21,592 participants in VITAL who agreed to be followed for an additional 2 years after discontinuation, the protection against autoimmune diseases from daily vitamin D (cholecalciferol; 2000 IU/d) was no longer statistically significant, but the benefits of daily marine n-3 FAs (1 g/d as a fish-oil capsule containing 460 mg of eicosapentaenoic acid and 380 mg of docosahexaenoic acid) remained significant.

“VITAL observational extension results suggest that vitamin D supplementation should be given on a continuous basis for long-term prevention of [autoimmune diseases]. The beneficial effects of n-3 fatty acids, however, may be prolonged for at least 2 years after discontinuation,” they wrote in an article published in Arthritis & Rheumatology.

Dr. Costenbader told this news organization that the results of the observational extension study suggest that the benefits of vitamin D “wear off more quickly, and it should be continued for a longer period of time or indefinitely, rather than only for 5 years.”

In addition to the disparity in the duration of the protective effect, the investigators also saw differences in the effects across different autoimmune diseases.

“The protective effect of vitamin D seemed strongest for psoriasis, while for omega-3 fatty acids, the protective effects were strongest for rheumatoid arthritis and inflammatory bowel disease,” she said.
 

Mixed Effects

In an interview with this news organization, Janet Funk, MD, MS, vice chair of research in the Department of Medicine and professor in the School of Nutritional Science and Wellness at the University of Arizona, Tucson, Arizona, who was not involved in the study, saidthat the results suggest that while each supplement may offer protection against autoimmune diseases, the effects are inconsistent and may not apply to all patients.

“I think the VITAL extension results suggest that either supplement (or both together) may have benefits in reducing risk of autoimmune diseases, including possible persistent effects posttreatment, but that these effects are nuanced (ie, only in normal weight post-vitamin D treatment) and possibly not uniform across all autoimmune diseases (including possible adverse effects for some — eg, inverse association between prior omega-3 and psoriasis and tendency for increased autoimmune thyroid disease for vitamin D), although the study was not powered sufficiently to draw disease-specific conclusions,” she said.

In an editorial accompanying the study, rheumatologist Joel M. Kremer, MD, of Albany Medical College and the Corrona Research Foundation in Delray Beach, Florida, wrote that “[T]he studies by Dr. Costenbader, et al. have shed new light on the possibility that dietary supplements of n-3 FA [fatty acid] may prevent the onset of [autoimmune disease]. The sustained benefits they describe for as long as 2 years after the supplements are discontinued are consistent with the chronicity of FA species in cellular plasma membranes where they serve as substrates for a diverse array of salient metabolic and inflammatory pathways.”
 

VITAL Then

To test whether vitamin D or marine-derived long-chain n-3 FA supplementation could protect against autoimmune disease over time, Dr. Costenbader and colleagues piggybacked an ancillary study onto the VITAL trial, which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older and 13,085 women aged 55 and older. The study had a 2 × 2 factorial design, with patients randomly assigned to vitamin D 2000 IU/d or placebo and then further randomized to either 1 g/d n-3 FAs or placebo in both the vitamin D and placebo primary randomization arms.

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with a hazard ratio (HR) of 0.68 (P = .02) for incident autoimmune disease, n-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03). However, when probable incident autoimmune disease cases were included, the effect of n-3 became significant, with an HR of 0.82.
 

VITAL Now

In the current analysis, Dr. Costenbader and colleagues reported observational data on 21,592 VITAL participants, a sample representing 83.5% of those who were initially randomized, and 87.9% of those who were alive and could be contacted at the end of the study.

As in the initial trial, the investigators used annual questionnaires to assess incident autoimmune diseases during the randomized follow-up. Participants were asked about new-onset, doctor-diagnosed rheumatoid arthritis, polymyalgia rheumatica, psoriasis, autoimmune thyroid disease, and inflammatory bowel disease. Participants could also write in any other new autoimmune disease diagnoses.

There were 236 new cases of confirmed autoimmune disease that occurred since the initial publication of the trial results, as well as 65 probable cases identified during the median 5.3 years of the randomized portion, and 42 probable cases diagnosed during the 2-year observational phase.

The investigators found that after the 2-year observation period, 255 participants initially randomized to receive vitamin D had a newly developed confirmed autoimmune disease, compared with 259 of those initially randomized to a vitamin D placebo. This translated into a nonsignificant HR of 0.98.

Adding probable autoimmune cases to the confirmed cases made little difference, resulting in a nonsignificant adjusted HR of 0.95.

In contrast, there were 234 confirmed autoimmune disease cases among patients initially assigned to n-3, compared with 280 among patients randomized to the n-3 placebo, translating into a statistically significant HR of 0.83 for new-onset autoimmune disease with n-3.

Dr. Costenbader and colleagues acknowledged that the study was limited by the use of doses intended to prevent cancer or cardiovascular disease and that higher doses intended for high-risk or nutritionally deficient populations might reveal larger effects of supplementation. In addition, they noted the difficulty of identifying the timing and onset of incident disease, and that the small number of cases that occurred during the 2-year observational period precluded detailed analyses of individual autoimmune diseases.

The study was funded by grants from the National Institutes of Health. Dr. Costenbader, Dr. Funk, and Dr. Kremer reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Two years after the end of a randomized trial that showed a benefit of daily vitamin D and omega-3 fatty acid (n-3 FA) supplementation for reducing risk for autoimmune diseases, the salubrious effects of daily vitamin D appear to have waned after the supplement was discontinued, while the protection from n-3 lived on for at least 2 additional years.

As previously reported, the randomized VITAL, which was designed primarily to study the effects of vitamin D and n-3 supplementation on incident cancer and cardiovascular disease, also showed that 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of n-3 FA supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases.

Now, investigators Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston, Massachusetts, and colleagues reported that among 21,592 participants in VITAL who agreed to be followed for an additional 2 years after discontinuation, the protection against autoimmune diseases from daily vitamin D (cholecalciferol; 2000 IU/d) was no longer statistically significant, but the benefits of daily marine n-3 FAs (1 g/d as a fish-oil capsule containing 460 mg of eicosapentaenoic acid and 380 mg of docosahexaenoic acid) remained significant.

“VITAL observational extension results suggest that vitamin D supplementation should be given on a continuous basis for long-term prevention of [autoimmune diseases]. The beneficial effects of n-3 fatty acids, however, may be prolonged for at least 2 years after discontinuation,” they wrote in an article published in Arthritis & Rheumatology.

Dr. Costenbader told this news organization that the results of the observational extension study suggest that the benefits of vitamin D “wear off more quickly, and it should be continued for a longer period of time or indefinitely, rather than only for 5 years.”

In addition to the disparity in the duration of the protective effect, the investigators also saw differences in the effects across different autoimmune diseases.

“The protective effect of vitamin D seemed strongest for psoriasis, while for omega-3 fatty acids, the protective effects were strongest for rheumatoid arthritis and inflammatory bowel disease,” she said.
 

Mixed Effects

In an interview with this news organization, Janet Funk, MD, MS, vice chair of research in the Department of Medicine and professor in the School of Nutritional Science and Wellness at the University of Arizona, Tucson, Arizona, who was not involved in the study, saidthat the results suggest that while each supplement may offer protection against autoimmune diseases, the effects are inconsistent and may not apply to all patients.

“I think the VITAL extension results suggest that either supplement (or both together) may have benefits in reducing risk of autoimmune diseases, including possible persistent effects posttreatment, but that these effects are nuanced (ie, only in normal weight post-vitamin D treatment) and possibly not uniform across all autoimmune diseases (including possible adverse effects for some — eg, inverse association between prior omega-3 and psoriasis and tendency for increased autoimmune thyroid disease for vitamin D), although the study was not powered sufficiently to draw disease-specific conclusions,” she said.

In an editorial accompanying the study, rheumatologist Joel M. Kremer, MD, of Albany Medical College and the Corrona Research Foundation in Delray Beach, Florida, wrote that “[T]he studies by Dr. Costenbader, et al. have shed new light on the possibility that dietary supplements of n-3 FA [fatty acid] may prevent the onset of [autoimmune disease]. The sustained benefits they describe for as long as 2 years after the supplements are discontinued are consistent with the chronicity of FA species in cellular plasma membranes where they serve as substrates for a diverse array of salient metabolic and inflammatory pathways.”
 

VITAL Then

To test whether vitamin D or marine-derived long-chain n-3 FA supplementation could protect against autoimmune disease over time, Dr. Costenbader and colleagues piggybacked an ancillary study onto the VITAL trial, which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older and 13,085 women aged 55 and older. The study had a 2 × 2 factorial design, with patients randomly assigned to vitamin D 2000 IU/d or placebo and then further randomized to either 1 g/d n-3 FAs or placebo in both the vitamin D and placebo primary randomization arms.

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with a hazard ratio (HR) of 0.68 (P = .02) for incident autoimmune disease, n-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03). However, when probable incident autoimmune disease cases were included, the effect of n-3 became significant, with an HR of 0.82.
 

VITAL Now

In the current analysis, Dr. Costenbader and colleagues reported observational data on 21,592 VITAL participants, a sample representing 83.5% of those who were initially randomized, and 87.9% of those who were alive and could be contacted at the end of the study.

As in the initial trial, the investigators used annual questionnaires to assess incident autoimmune diseases during the randomized follow-up. Participants were asked about new-onset, doctor-diagnosed rheumatoid arthritis, polymyalgia rheumatica, psoriasis, autoimmune thyroid disease, and inflammatory bowel disease. Participants could also write in any other new autoimmune disease diagnoses.

There were 236 new cases of confirmed autoimmune disease that occurred since the initial publication of the trial results, as well as 65 probable cases identified during the median 5.3 years of the randomized portion, and 42 probable cases diagnosed during the 2-year observational phase.

The investigators found that after the 2-year observation period, 255 participants initially randomized to receive vitamin D had a newly developed confirmed autoimmune disease, compared with 259 of those initially randomized to a vitamin D placebo. This translated into a nonsignificant HR of 0.98.

Adding probable autoimmune cases to the confirmed cases made little difference, resulting in a nonsignificant adjusted HR of 0.95.

In contrast, there were 234 confirmed autoimmune disease cases among patients initially assigned to n-3, compared with 280 among patients randomized to the n-3 placebo, translating into a statistically significant HR of 0.83 for new-onset autoimmune disease with n-3.

Dr. Costenbader and colleagues acknowledged that the study was limited by the use of doses intended to prevent cancer or cardiovascular disease and that higher doses intended for high-risk or nutritionally deficient populations might reveal larger effects of supplementation. In addition, they noted the difficulty of identifying the timing and onset of incident disease, and that the small number of cases that occurred during the 2-year observational period precluded detailed analyses of individual autoimmune diseases.

The study was funded by grants from the National Institutes of Health. Dr. Costenbader, Dr. Funk, and Dr. Kremer reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

People with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2) inhibitors show a significantly reduced risk of developing kidney stones compared with those treated with other commonly used diabetes drugs.

“To our knowledge, this study is the first and largest to assess the association between SGLT2 inhibitors use and risk of nephrolithiasis [kidney stones] in patients with type 2 diabetes in routine US clinical practice,” said the authors of the study, published in JAMA Internal Medicine. 

“Our results suggest that for patients with type 2 diabetes, the individual risk profile for developing nephrolithiasis could be a consideration when deciding which glucose-lowering agent patients should initiate,” they wrote.

The prevalence of kidney stones has been on the rise, and the problem is especially relevant to those with type 2 diabetes, which is known to have an increased risk of kidney stones, potentially causing severe pain and leading to kidney function decline.

With SGLT2 inhibitors showing renoprotective, in addition to cardiovascular benefits, first author Julie Paik, MD, MPH, an associate professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics and the Division of Renal (Kidney) Medicine at Brigham and Women’s Hospital in Boston, Massachusetts, and colleagues conducted an active comparator cohort study using data from three nationwide databases on patients with type 2 diabetes in routine clinical practice.

In the study’s two arms of propensity score-matched patients, 358,203 pairs of patients with type 2 diabetes were matched 1:1 to either those who were new users of SGLT2 inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), with patients in those groups having a mean age of 61 and being about 51% female.

In addition, 331,028 pairs matched new SGLT2 inhibitor users 1:1 with didpeptidyl peptidase-4 (DPP4) inhibitor users, who also had a mean age of about 61.5 years and were about 47% female.

Over a median follow-up of 192 days, those treated with SGLT2 inhibitors had about a 31% significantly lower risk of kidney stones than GLP-1RA users (14.9 vs 21.3 events per 1000 person-years; hazard ratio [HR], 0.69).

And the SGLT2 group also had a 26% lower kidney stone risk vs DPP4 inhibitor users (14.6 vs 19.9 events per 1000 person-years; HR, 0.74).

There were no differences in the results with either groups of pairs based on sex, race, ethnicity, a history of chronic kidney disease, or obesity.

Of note, the magnitude of the risk reduction observed with SGLT2 inhibitors was greater in adults aged < 70 years than in those aged ≥ 70 years (HR, 0.85; P for interaction < .001).

The age-related difference could possibly be due to changes in stone composition that occurs with aging, which may influence SGLT2 inhibitor response, Dr Paik told this news organization.

“However, we did not have information on stone composition in our study.”

In the study, patients were taking, on average, more than two antidiabetic medications upon entrance to the study, with 13% taking thiazides and 12% taking loop diuretics. In addition, approximately half of patients discontinued SGLT2 inhibitors (52.6%) and DPP4 inhibitors (53.2%).

However, the results remained consistent after adjusting for those factors, Dr. Paik noted.
 

Mechanisms: Urinary Citrate Excretion?

Among key possible explanations for the lower risk of kidney stones with SGLT2 inhibitors is that the drugs have increased urinary citrate excretion, with one study showing a nearly 50% increase in urinary citrate excretion among patients treated with empagliflozin vs placebo over 4 weeks and other studies also showing similar increases.

“This increased urinary citrate excretion may play a pivotal role in decreasing stone risk by inhibiting supersaturation and crystallization of calcium crystals,” the authors explained.

In addition, the urinary citrate excretion could further play a role by “forming complexes with calcium and thus lowering urinary calcium concentration, and raising urinary pH, thereby reducing the risk of uric acid stones,” they added.

SGLT inhibitors’ anti-inflammatory effects could also reduce stone formation by “suppressing the expression of a stone core matrix protein, osteopontin, and markers of kidney injury, inflammation, and macrophages that promote stone formation,” the authors noted.

Ultimately, however, “while we found a lower risk of kidney stones in our study, we don’t fully understand how they lower the risk,” Dr. Paik said. The potential explanations “remain to be studied further.”

Either way, “the risk of kidney stones in a patient might be one additional consideration for a clinician to take into account when choosing among the different glucose-lowering agents for patients with type 2 diabetes,” Dr. Paik said.

The study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, the National Institute of Aging the Patient-Centered Outcomes Research Institute, the US Food and Drug Administration, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

A version of this article appeared on Medscape.com .

People with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2) inhibitors show a significantly reduced risk of developing kidney stones compared with those treated with other commonly used diabetes drugs.

“To our knowledge, this study is the first and largest to assess the association between SGLT2 inhibitors use and risk of nephrolithiasis [kidney stones] in patients with type 2 diabetes in routine US clinical practice,” said the authors of the study, published in JAMA Internal Medicine. 

“Our results suggest that for patients with type 2 diabetes, the individual risk profile for developing nephrolithiasis could be a consideration when deciding which glucose-lowering agent patients should initiate,” they wrote.

The prevalence of kidney stones has been on the rise, and the problem is especially relevant to those with type 2 diabetes, which is known to have an increased risk of kidney stones, potentially causing severe pain and leading to kidney function decline.

With SGLT2 inhibitors showing renoprotective, in addition to cardiovascular benefits, first author Julie Paik, MD, MPH, an associate professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics and the Division of Renal (Kidney) Medicine at Brigham and Women’s Hospital in Boston, Massachusetts, and colleagues conducted an active comparator cohort study using data from three nationwide databases on patients with type 2 diabetes in routine clinical practice.

In the study’s two arms of propensity score-matched patients, 358,203 pairs of patients with type 2 diabetes were matched 1:1 to either those who were new users of SGLT2 inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), with patients in those groups having a mean age of 61 and being about 51% female.

In addition, 331,028 pairs matched new SGLT2 inhibitor users 1:1 with didpeptidyl peptidase-4 (DPP4) inhibitor users, who also had a mean age of about 61.5 years and were about 47% female.

Over a median follow-up of 192 days, those treated with SGLT2 inhibitors had about a 31% significantly lower risk of kidney stones than GLP-1RA users (14.9 vs 21.3 events per 1000 person-years; hazard ratio [HR], 0.69).

And the SGLT2 group also had a 26% lower kidney stone risk vs DPP4 inhibitor users (14.6 vs 19.9 events per 1000 person-years; HR, 0.74).

There were no differences in the results with either groups of pairs based on sex, race, ethnicity, a history of chronic kidney disease, or obesity.

Of note, the magnitude of the risk reduction observed with SGLT2 inhibitors was greater in adults aged < 70 years than in those aged ≥ 70 years (HR, 0.85; P for interaction < .001).

The age-related difference could possibly be due to changes in stone composition that occurs with aging, which may influence SGLT2 inhibitor response, Dr Paik told this news organization.

“However, we did not have information on stone composition in our study.”

In the study, patients were taking, on average, more than two antidiabetic medications upon entrance to the study, with 13% taking thiazides and 12% taking loop diuretics. In addition, approximately half of patients discontinued SGLT2 inhibitors (52.6%) and DPP4 inhibitors (53.2%).

However, the results remained consistent after adjusting for those factors, Dr. Paik noted.
 

Mechanisms: Urinary Citrate Excretion?

Among key possible explanations for the lower risk of kidney stones with SGLT2 inhibitors is that the drugs have increased urinary citrate excretion, with one study showing a nearly 50% increase in urinary citrate excretion among patients treated with empagliflozin vs placebo over 4 weeks and other studies also showing similar increases.

“This increased urinary citrate excretion may play a pivotal role in decreasing stone risk by inhibiting supersaturation and crystallization of calcium crystals,” the authors explained.

In addition, the urinary citrate excretion could further play a role by “forming complexes with calcium and thus lowering urinary calcium concentration, and raising urinary pH, thereby reducing the risk of uric acid stones,” they added.

SGLT inhibitors’ anti-inflammatory effects could also reduce stone formation by “suppressing the expression of a stone core matrix protein, osteopontin, and markers of kidney injury, inflammation, and macrophages that promote stone formation,” the authors noted.

Ultimately, however, “while we found a lower risk of kidney stones in our study, we don’t fully understand how they lower the risk,” Dr. Paik said. The potential explanations “remain to be studied further.”

Either way, “the risk of kidney stones in a patient might be one additional consideration for a clinician to take into account when choosing among the different glucose-lowering agents for patients with type 2 diabetes,” Dr. Paik said.

The study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, the National Institute of Aging the Patient-Centered Outcomes Research Institute, the US Food and Drug Administration, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

A version of this article appeared on Medscape.com .

People with type 2 diabetes treated with sodium-glucose cotransporter 2 inhibitors (SGLT2) inhibitors show a significantly reduced risk of developing kidney stones compared with those treated with other commonly used diabetes drugs.

“To our knowledge, this study is the first and largest to assess the association between SGLT2 inhibitors use and risk of nephrolithiasis [kidney stones] in patients with type 2 diabetes in routine US clinical practice,” said the authors of the study, published in JAMA Internal Medicine. 

“Our results suggest that for patients with type 2 diabetes, the individual risk profile for developing nephrolithiasis could be a consideration when deciding which glucose-lowering agent patients should initiate,” they wrote.

The prevalence of kidney stones has been on the rise, and the problem is especially relevant to those with type 2 diabetes, which is known to have an increased risk of kidney stones, potentially causing severe pain and leading to kidney function decline.

With SGLT2 inhibitors showing renoprotective, in addition to cardiovascular benefits, first author Julie Paik, MD, MPH, an associate professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics and the Division of Renal (Kidney) Medicine at Brigham and Women’s Hospital in Boston, Massachusetts, and colleagues conducted an active comparator cohort study using data from three nationwide databases on patients with type 2 diabetes in routine clinical practice.

In the study’s two arms of propensity score-matched patients, 358,203 pairs of patients with type 2 diabetes were matched 1:1 to either those who were new users of SGLT2 inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), with patients in those groups having a mean age of 61 and being about 51% female.

In addition, 331,028 pairs matched new SGLT2 inhibitor users 1:1 with didpeptidyl peptidase-4 (DPP4) inhibitor users, who also had a mean age of about 61.5 years and were about 47% female.

Over a median follow-up of 192 days, those treated with SGLT2 inhibitors had about a 31% significantly lower risk of kidney stones than GLP-1RA users (14.9 vs 21.3 events per 1000 person-years; hazard ratio [HR], 0.69).

And the SGLT2 group also had a 26% lower kidney stone risk vs DPP4 inhibitor users (14.6 vs 19.9 events per 1000 person-years; HR, 0.74).

There were no differences in the results with either groups of pairs based on sex, race, ethnicity, a history of chronic kidney disease, or obesity.

Of note, the magnitude of the risk reduction observed with SGLT2 inhibitors was greater in adults aged < 70 years than in those aged ≥ 70 years (HR, 0.85; P for interaction < .001).

The age-related difference could possibly be due to changes in stone composition that occurs with aging, which may influence SGLT2 inhibitor response, Dr Paik told this news organization.

“However, we did not have information on stone composition in our study.”

In the study, patients were taking, on average, more than two antidiabetic medications upon entrance to the study, with 13% taking thiazides and 12% taking loop diuretics. In addition, approximately half of patients discontinued SGLT2 inhibitors (52.6%) and DPP4 inhibitors (53.2%).

However, the results remained consistent after adjusting for those factors, Dr. Paik noted.
 

Mechanisms: Urinary Citrate Excretion?

Among key possible explanations for the lower risk of kidney stones with SGLT2 inhibitors is that the drugs have increased urinary citrate excretion, with one study showing a nearly 50% increase in urinary citrate excretion among patients treated with empagliflozin vs placebo over 4 weeks and other studies also showing similar increases.

“This increased urinary citrate excretion may play a pivotal role in decreasing stone risk by inhibiting supersaturation and crystallization of calcium crystals,” the authors explained.

In addition, the urinary citrate excretion could further play a role by “forming complexes with calcium and thus lowering urinary calcium concentration, and raising urinary pH, thereby reducing the risk of uric acid stones,” they added.

SGLT inhibitors’ anti-inflammatory effects could also reduce stone formation by “suppressing the expression of a stone core matrix protein, osteopontin, and markers of kidney injury, inflammation, and macrophages that promote stone formation,” the authors noted.

Ultimately, however, “while we found a lower risk of kidney stones in our study, we don’t fully understand how they lower the risk,” Dr. Paik said. The potential explanations “remain to be studied further.”

Either way, “the risk of kidney stones in a patient might be one additional consideration for a clinician to take into account when choosing among the different glucose-lowering agents for patients with type 2 diabetes,” Dr. Paik said.

The study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, the National Institute of Aging the Patient-Centered Outcomes Research Institute, the US Food and Drug Administration, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 

A version of this article appeared on Medscape.com .

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .