MDedge Endocrinology

Twice-daily esmolol hydrochloride gel (Galnobax, NovaLead) appears to significantly improve closure of diabetic foot ulcers, particularly in patients with risk factors for impeded wound healing, say Indian researchers.
 

Esmolol is a short-acting beta-adrenergic receptor blocker that is currently approved by the Food and Drug Administration for cardiac indications such as short-term use for supraventricular tachycardia.

As a gel, esmolol hydrochloride is administered topically to stimulate wound healing via mechanisms such as the migration of keratinocytes, fibroblasts, and endothelial cells into wound tissue.

The current trial enrolled patients with type 1 or 2 diabetes, finding that, among 140 assessed, target ulcer closure within 12 weeks was more than twice as likely in those assigned esmolol gel plus standard of care than those given standard of care alone.

The impact of adding esmolol gel to standard of care was even greater in patients with a body mass index (BMI) over 25 kg/m² and in those who weighed more than 80 kg (176 lb).

“The use of esmolol in the treatment of diabetic foot ulcers in addition to standard of care may be an important addition to the endeavor of healing diabetic foot ulcers,” wrote Ashu Rastogi, MD, DM, department of endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India, and colleagues, in their article recently published in JAMA Network Open.

Dr. Rastogi first presented the findings at the 2022 annual meeting of the European Association for the Study of Diabetes. The results were well received, with one clinician describing them as “astounding.”

However, Andrew Boulton, MD, PhD, said in an interview that, although the final published data are “interesting,” they “need further confirmation” because “there are one or two unusual features” about the study. Dr. Boulton is a professor of medicine, division of diabetes, endocrinology & gastroenterology, at the University of Manchester (England).

He highlighted that the study was of “basically neuropathic ulcers, many of which were plantar and should be able to heal without any specific additional therapy.”

In addition, the inclusion criteria state that the ulcers could be below the malleoli or 5 cm above them, which Dr. Boulton explained is “very unusual and would therefore include some atypical and not truly diabetic ‘foot’ ulcers.”

And Frances Game, MBBCh, department of diabetes and endocrinology, University Hospitals of Derby (England) and Burton NHS Foundation Trust, added that there are questions about the study methodology.

She said in an interview that although it is a “fascinating study,” the main comparison group did not receive vehicle, or placebo, gel in addition to standard of care. “How were they blinded [to treatment]?”

The “biggest problem” with the study, however, is that the primary outcome was reported as a per-protocol endpoint, not as a standard intention-to-treat analysis, which allowed the researchers to exclude patients whose ulcers increased in size by over 30% on two consecutive visits.

“That kind of makes [esmolol gel] look better than it is because they’ve taken out the ones who got worse,” Dr. Game noted. However, the findings, while not conclusive, do warrant further study of esmolol gel.

The authors noted that diabetic foot ulcers are a severe complication of diabetes, with a prevalence of 1.3%-12.0% across various countries, And the complication contributes to patient morbidity and mortality, with a 5-year mortality that is substantially higher than that of many cancers.

Moreover, “even with the best therapy,” such as advanced moist wound therapy, bioengineered tissue or skin substitutes, peptides, growth factors, electric stimulation, and negative-pressure wound therapy, just 30% of wounds linked to diabetes heal and recurrence is as high as 70%.

Against this backdrop, topical esmolol 14% gel was shown in a phase 1/2 study to be associated with ulcer area reduction and earlier wound closure versus standard of care plus a control vehicle gel.

The current phase 3, randomized, controlled trial involved individuals aged 18-75 years with type 1 or type 2 diabetes and noninfected diabetic foot ulcers classified as grade 1A and 1C on the University of Texas Wound Classification System, which had been open for at least 6 weeks and had an area of 2-25 cm2.

Patients from 27 tertiary care centers across India were enrolled in 2018-2020. They were randomized in a 3:3:1 ratio to one of three groups: esmolol 14% gel plus standard of care, standard of care only, or vehicle plus standard of care.

The study lasted 25 weeks and included a 1-week screening phase, during which all patients received standard of care, a 12-week treatment phase, and a 12-week follow-up phase. The latter included a closure confirmation period of 4 weeks and an observation period of 8 weeks.

Patients were assessed once a week during the treatment phase, and then at weeks 14, 16, 20, and 24.

In all, 176 patients were enrolled. Participants were a mean age of 56.4 years and 69.3% were men. Average hemoglobin A1c was 8.6%. Mean diabetic foot ulcer area was 4.7 cm² and the average ulcer duration was 49.8 weeks.

The primary outcome was the proportion of patients who achieved target ulcer closure during the 12-week treatment phase and was assessed in 140 patients.

Overall, 60.3% of patients treated with esmolol gel plus standard of care achieved target ulcer closure versus 41.7% of those in the standard of care alone group (odds ratio, 2.13; P = .03).

The secondary outcome was the proportion of patients with target ulcer closure by the study end and was assessed in 120 patients.

In total, 77.2% of patients in the esmolol gel plus standard of care group met the secondary endpoint, compared with 55.6% of those receiving standard of care alone (OR, 1.72; P = .01).

Further analysis suggested the benefit seen with esmolol gel plus standard of care was greater in patients with a weight greater than 80 kg versus standard of care alone (OR, 4.04; P = .04), and in those with a BMI greater than 25 (OR, 2.72; P = .03).

Treatment-emergent adverse events were reported by 33 (18.8%) participants, with 12 events deemed serious. “However, none of the serious adverse events were considered as drug-related by the investigators,” concluded the researchers.

The study was partly funded by NovaLead Pharma and the Biotechnology Industry Research Assistance Council, New Delhi, set up by the Department of Biotechnology, Government of India. Dr. Rastogi reported no relevant financial relationships.

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

Twice-daily esmolol hydrochloride gel (Galnobax, NovaLead) appears to significantly improve closure of diabetic foot ulcers, particularly in patients with risk factors for impeded wound healing, say Indian researchers.
 

Esmolol is a short-acting beta-adrenergic receptor blocker that is currently approved by the Food and Drug Administration for cardiac indications such as short-term use for supraventricular tachycardia.

As a gel, esmolol hydrochloride is administered topically to stimulate wound healing via mechanisms such as the migration of keratinocytes, fibroblasts, and endothelial cells into wound tissue.

The current trial enrolled patients with type 1 or 2 diabetes, finding that, among 140 assessed, target ulcer closure within 12 weeks was more than twice as likely in those assigned esmolol gel plus standard of care than those given standard of care alone.

The impact of adding esmolol gel to standard of care was even greater in patients with a body mass index (BMI) over 25 kg/m² and in those who weighed more than 80 kg (176 lb).

“The use of esmolol in the treatment of diabetic foot ulcers in addition to standard of care may be an important addition to the endeavor of healing diabetic foot ulcers,” wrote Ashu Rastogi, MD, DM, department of endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India, and colleagues, in their article recently published in JAMA Network Open.

Dr. Rastogi first presented the findings at the 2022 annual meeting of the European Association for the Study of Diabetes. The results were well received, with one clinician describing them as “astounding.”

However, Andrew Boulton, MD, PhD, said in an interview that, although the final published data are “interesting,” they “need further confirmation” because “there are one or two unusual features” about the study. Dr. Boulton is a professor of medicine, division of diabetes, endocrinology & gastroenterology, at the University of Manchester (England).

He highlighted that the study was of “basically neuropathic ulcers, many of which were plantar and should be able to heal without any specific additional therapy.”

In addition, the inclusion criteria state that the ulcers could be below the malleoli or 5 cm above them, which Dr. Boulton explained is “very unusual and would therefore include some atypical and not truly diabetic ‘foot’ ulcers.”

And Frances Game, MBBCh, department of diabetes and endocrinology, University Hospitals of Derby (England) and Burton NHS Foundation Trust, added that there are questions about the study methodology.

She said in an interview that although it is a “fascinating study,” the main comparison group did not receive vehicle, or placebo, gel in addition to standard of care. “How were they blinded [to treatment]?”

The “biggest problem” with the study, however, is that the primary outcome was reported as a per-protocol endpoint, not as a standard intention-to-treat analysis, which allowed the researchers to exclude patients whose ulcers increased in size by over 30% on two consecutive visits.

“That kind of makes [esmolol gel] look better than it is because they’ve taken out the ones who got worse,” Dr. Game noted. However, the findings, while not conclusive, do warrant further study of esmolol gel.

The authors noted that diabetic foot ulcers are a severe complication of diabetes, with a prevalence of 1.3%-12.0% across various countries, And the complication contributes to patient morbidity and mortality, with a 5-year mortality that is substantially higher than that of many cancers.

Moreover, “even with the best therapy,” such as advanced moist wound therapy, bioengineered tissue or skin substitutes, peptides, growth factors, electric stimulation, and negative-pressure wound therapy, just 30% of wounds linked to diabetes heal and recurrence is as high as 70%.

Against this backdrop, topical esmolol 14% gel was shown in a phase 1/2 study to be associated with ulcer area reduction and earlier wound closure versus standard of care plus a control vehicle gel.

The current phase 3, randomized, controlled trial involved individuals aged 18-75 years with type 1 or type 2 diabetes and noninfected diabetic foot ulcers classified as grade 1A and 1C on the University of Texas Wound Classification System, which had been open for at least 6 weeks and had an area of 2-25 cm2.

Patients from 27 tertiary care centers across India were enrolled in 2018-2020. They were randomized in a 3:3:1 ratio to one of three groups: esmolol 14% gel plus standard of care, standard of care only, or vehicle plus standard of care.

The study lasted 25 weeks and included a 1-week screening phase, during which all patients received standard of care, a 12-week treatment phase, and a 12-week follow-up phase. The latter included a closure confirmation period of 4 weeks and an observation period of 8 weeks.

Patients were assessed once a week during the treatment phase, and then at weeks 14, 16, 20, and 24.

In all, 176 patients were enrolled. Participants were a mean age of 56.4 years and 69.3% were men. Average hemoglobin A1c was 8.6%. Mean diabetic foot ulcer area was 4.7 cm² and the average ulcer duration was 49.8 weeks.

The primary outcome was the proportion of patients who achieved target ulcer closure during the 12-week treatment phase and was assessed in 140 patients.

Overall, 60.3% of patients treated with esmolol gel plus standard of care achieved target ulcer closure versus 41.7% of those in the standard of care alone group (odds ratio, 2.13; P = .03).

The secondary outcome was the proportion of patients with target ulcer closure by the study end and was assessed in 120 patients.

In total, 77.2% of patients in the esmolol gel plus standard of care group met the secondary endpoint, compared with 55.6% of those receiving standard of care alone (OR, 1.72; P = .01).

Further analysis suggested the benefit seen with esmolol gel plus standard of care was greater in patients with a weight greater than 80 kg versus standard of care alone (OR, 4.04; P = .04), and in those with a BMI greater than 25 (OR, 2.72; P = .03).

Treatment-emergent adverse events were reported by 33 (18.8%) participants, with 12 events deemed serious. “However, none of the serious adverse events were considered as drug-related by the investigators,” concluded the researchers.

The study was partly funded by NovaLead Pharma and the Biotechnology Industry Research Assistance Council, New Delhi, set up by the Department of Biotechnology, Government of India. Dr. Rastogi reported no relevant financial relationships.

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

Twice-daily esmolol hydrochloride gel (Galnobax, NovaLead) appears to significantly improve closure of diabetic foot ulcers, particularly in patients with risk factors for impeded wound healing, say Indian researchers.
 

Esmolol is a short-acting beta-adrenergic receptor blocker that is currently approved by the Food and Drug Administration for cardiac indications such as short-term use for supraventricular tachycardia.

As a gel, esmolol hydrochloride is administered topically to stimulate wound healing via mechanisms such as the migration of keratinocytes, fibroblasts, and endothelial cells into wound tissue.

The current trial enrolled patients with type 1 or 2 diabetes, finding that, among 140 assessed, target ulcer closure within 12 weeks was more than twice as likely in those assigned esmolol gel plus standard of care than those given standard of care alone.

The impact of adding esmolol gel to standard of care was even greater in patients with a body mass index (BMI) over 25 kg/m² and in those who weighed more than 80 kg (176 lb).

“The use of esmolol in the treatment of diabetic foot ulcers in addition to standard of care may be an important addition to the endeavor of healing diabetic foot ulcers,” wrote Ashu Rastogi, MD, DM, department of endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India, and colleagues, in their article recently published in JAMA Network Open.

Dr. Rastogi first presented the findings at the 2022 annual meeting of the European Association for the Study of Diabetes. The results were well received, with one clinician describing them as “astounding.”

However, Andrew Boulton, MD, PhD, said in an interview that, although the final published data are “interesting,” they “need further confirmation” because “there are one or two unusual features” about the study. Dr. Boulton is a professor of medicine, division of diabetes, endocrinology & gastroenterology, at the University of Manchester (England).

He highlighted that the study was of “basically neuropathic ulcers, many of which were plantar and should be able to heal without any specific additional therapy.”

In addition, the inclusion criteria state that the ulcers could be below the malleoli or 5 cm above them, which Dr. Boulton explained is “very unusual and would therefore include some atypical and not truly diabetic ‘foot’ ulcers.”

And Frances Game, MBBCh, department of diabetes and endocrinology, University Hospitals of Derby (England) and Burton NHS Foundation Trust, added that there are questions about the study methodology.

She said in an interview that although it is a “fascinating study,” the main comparison group did not receive vehicle, or placebo, gel in addition to standard of care. “How were they blinded [to treatment]?”

The “biggest problem” with the study, however, is that the primary outcome was reported as a per-protocol endpoint, not as a standard intention-to-treat analysis, which allowed the researchers to exclude patients whose ulcers increased in size by over 30% on two consecutive visits.

“That kind of makes [esmolol gel] look better than it is because they’ve taken out the ones who got worse,” Dr. Game noted. However, the findings, while not conclusive, do warrant further study of esmolol gel.

The authors noted that diabetic foot ulcers are a severe complication of diabetes, with a prevalence of 1.3%-12.0% across various countries, And the complication contributes to patient morbidity and mortality, with a 5-year mortality that is substantially higher than that of many cancers.

Moreover, “even with the best therapy,” such as advanced moist wound therapy, bioengineered tissue or skin substitutes, peptides, growth factors, electric stimulation, and negative-pressure wound therapy, just 30% of wounds linked to diabetes heal and recurrence is as high as 70%.

Against this backdrop, topical esmolol 14% gel was shown in a phase 1/2 study to be associated with ulcer area reduction and earlier wound closure versus standard of care plus a control vehicle gel.

The current phase 3, randomized, controlled trial involved individuals aged 18-75 years with type 1 or type 2 diabetes and noninfected diabetic foot ulcers classified as grade 1A and 1C on the University of Texas Wound Classification System, which had been open for at least 6 weeks and had an area of 2-25 cm2.

Patients from 27 tertiary care centers across India were enrolled in 2018-2020. They were randomized in a 3:3:1 ratio to one of three groups: esmolol 14% gel plus standard of care, standard of care only, or vehicle plus standard of care.

The study lasted 25 weeks and included a 1-week screening phase, during which all patients received standard of care, a 12-week treatment phase, and a 12-week follow-up phase. The latter included a closure confirmation period of 4 weeks and an observation period of 8 weeks.

Patients were assessed once a week during the treatment phase, and then at weeks 14, 16, 20, and 24.

In all, 176 patients were enrolled. Participants were a mean age of 56.4 years and 69.3% were men. Average hemoglobin A1c was 8.6%. Mean diabetic foot ulcer area was 4.7 cm² and the average ulcer duration was 49.8 weeks.

The primary outcome was the proportion of patients who achieved target ulcer closure during the 12-week treatment phase and was assessed in 140 patients.

Overall, 60.3% of patients treated with esmolol gel plus standard of care achieved target ulcer closure versus 41.7% of those in the standard of care alone group (odds ratio, 2.13; P = .03).

The secondary outcome was the proportion of patients with target ulcer closure by the study end and was assessed in 120 patients.

In total, 77.2% of patients in the esmolol gel plus standard of care group met the secondary endpoint, compared with 55.6% of those receiving standard of care alone (OR, 1.72; P = .01).

Further analysis suggested the benefit seen with esmolol gel plus standard of care was greater in patients with a weight greater than 80 kg versus standard of care alone (OR, 4.04; P = .04), and in those with a BMI greater than 25 (OR, 2.72; P = .03).

Treatment-emergent adverse events were reported by 33 (18.8%) participants, with 12 events deemed serious. “However, none of the serious adverse events were considered as drug-related by the investigators,” concluded the researchers.

The study was partly funded by NovaLead Pharma and the Biotechnology Industry Research Assistance Council, New Delhi, set up by the Department of Biotechnology, Government of India. Dr. Rastogi reported no relevant financial relationships.

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

Screening for and treating chronic kidney disease (CKD) in all U.S. adults 35-75 years old is cost effective using a strategy that starts by measuring their urine albumin-creatinine ratio (UACR) followed by confirmatory tests and treatment of confirmed cases with current standard-care medications, according to an analysis published in the Annals of Internal Medicine.

This new evidence may prove important as the U.S. Preventive Services Task Force has begun revisiting its 2012 conclusion that “evidence is insufficient to assess the balance of benefits and harms of routine screening for chronic kidney disease in asymptomatic adults.”

A big difference between 2012 and today has been that sodium-glucose cotransporter 2 (SGLT2) inhibitors arrived on the scene as an important complement to well-established treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. SGLT2 inhibitors have been documented as safe and effective for slowing CKD progression regardless of a person’s diabetes status, and have “dramatically altered” first-line treatment of adults with CKD, wrote the authors of the new study.
 

‘Large population health gains’ from CKD screening

“Given the high prevalence of CKD, even among those without risk factors, low-cost screening combined with effective treatment using SGLT2 inhibitors represent value,” explained Marika M. Cusick, lead author of the report, a PhD student, and a health policy researcher at Stanford (Calif.) University. “Our results show large population health gains can be achieved through CKD screening,” she said in an interview.

“This is a well-designed cost-effectiveness analysis that, importantly, considers newer treatments shown to be effective for slowing progression of CKD. The overall findings are convincing,” commented Deidra C. Crews, MD, a nephrologist and professor at Johns Hopkins University in Baltimore who was not involved in the research.

Dr. Crews, who is also president-elect of the American Society of Nephrology noted that the findings “may be a conservative estimate of the cost-effectiveness of CKD screening in certain subgroups, particularly when considering profound racial, ethnic and socioeconomic disparities in survival and CKD progression.”

The USPSTF starts a relook

The new evidence of cost-effectiveness of routine CKD screening follows the USPSTF’s release in January 2023 of a draft research plan to reassess the potential role for CKD screening of asymptomatic adults in the United States, the first step on a potential path to a revised set of recommendations. Public comment on the draft plan closed in February, and based on the standard USPSTF development steps and time frames, a final recommendation statement could appear by early 2026.

Revisiting the prior USPSTF decision from 2012 received endorsement earlier in 2023 from the ASN. The organization issued a statement last January that cited “more than a decade of advocacy in support of more kidney health screening by ASN and other stakeholders dedicated to intervening earlier to slow or stop the progression of kidney diseases.”

A more detailed letter of support for CKD screening sent to top USPSTF officials followed in February 2023 from ASN president Michelle A. Josephson, MD, who said in part that “ASN believes that kidney care is at an inflection point. There are now far more novel therapeutics to slow the progression of CKD, evidence to support the impact of nonpharmacologic interventions on CKD, and an increased commitment in public health to confront disparities and their causes.”
 

USPSTF recommendation could make a difference

Dr. Josephson also cited the modest effect that CKD screening recommendations from other groups have had up to now.

“Although guidance from Kidney Disease Improving Global Outcomes and the National Kidney Foundation recommends CKD screening among patients with hypertension, only approximately 10% of individuals with hypertension receive yearly screening. Furthermore, American Diabetes Association guidelines recommend yearly CKD screening in patients with diabetes, but only 40%-50% of patients receive this.”

“USPSTF recommendations tend to reach clinicians in primary care settings, where screening for diseases most commonly occurs, much more than recommendations from professional or patient organizations,” Dr. Crews said in an interview. “USPSTF recommendations also often influence health policies that might financially incentivize clinicians and health systems to screen their patients.”

“We hope [the USPSTF] will be interested in including our results within the totality of evidence assessed in their review of CKD screening,” said Ms. Cusick.
 

Preventing hundreds of thousands dialysis cases

The Stanford researchers developed a decision analytic Markov cohort model of CKD progression in U.S. adults aged 35 years or older and fit their model to data from the National Health and Nutrition Examination Survey (NHANES). They found that implementing one-time screening and adding SGLT2 inhibitors to treatment of the 158 million U.S. adults 35-75 years old would prevent the need for kidney replacement therapy (dialysis or transplant) in approximately 398,000 people over their lifetimes, representing a 10% decrease in such cases, compared with the status quo. Screening every 10 or 5 years combined with SGLT2 inhibitors would prevent approximately 598,000 or 658,000 people, respectively, from requiring kidney replacement therapy, compared with not screening.

Analysis showed that one-time screening produced an incremental cost-effectiveness ratio of $86,300 per quality-adjusted life-year (QALY) gained when one-time screening occurred in adults when they reached 55 years old. Screening every 10 years until people became 75 years old cost $98,400 per QALY gained for this group when adults were 35 years old, and $89,800 per QALY gained when screening occurred at 65 years old. These QALY costs are less than “commonly used” U.S. thresholds for acceptable cost-effectiveness of $100,000-$150,000 per QALY gained, the authors said.

Ms. Cusick highlighted the advantages of population-level screening for all U.S. adults, including those who are asymptomatic, compared with focusing on adults with risk factors, such as hypertension or diabetes.

“While risk-based screening can be more cost effective in some settings, risk factors are not always known, especially in marginalized and disadvantaged populations. This may lead to disparities in the use of screening and downstream health outcomes that could be avoided through universal screening policies,” she explained.

The study received no commercial funding. Ms. Cusick had no disclosures. Dr. Crews has received research grants from Somatus. Dr. Josephson has been a consultant to Exosome Diagnostics, IMMUCOR, Labcorp, Otsuka, UBC, and Vera Therapeutics, and has an ownership interest in Seagen.

Screening for and treating chronic kidney disease (CKD) in all U.S. adults 35-75 years old is cost effective using a strategy that starts by measuring their urine albumin-creatinine ratio (UACR) followed by confirmatory tests and treatment of confirmed cases with current standard-care medications, according to an analysis published in the Annals of Internal Medicine.

This new evidence may prove important as the U.S. Preventive Services Task Force has begun revisiting its 2012 conclusion that “evidence is insufficient to assess the balance of benefits and harms of routine screening for chronic kidney disease in asymptomatic adults.”

A big difference between 2012 and today has been that sodium-glucose cotransporter 2 (SGLT2) inhibitors arrived on the scene as an important complement to well-established treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. SGLT2 inhibitors have been documented as safe and effective for slowing CKD progression regardless of a person’s diabetes status, and have “dramatically altered” first-line treatment of adults with CKD, wrote the authors of the new study.
 

‘Large population health gains’ from CKD screening

“Given the high prevalence of CKD, even among those without risk factors, low-cost screening combined with effective treatment using SGLT2 inhibitors represent value,” explained Marika M. Cusick, lead author of the report, a PhD student, and a health policy researcher at Stanford (Calif.) University. “Our results show large population health gains can be achieved through CKD screening,” she said in an interview.

“This is a well-designed cost-effectiveness analysis that, importantly, considers newer treatments shown to be effective for slowing progression of CKD. The overall findings are convincing,” commented Deidra C. Crews, MD, a nephrologist and professor at Johns Hopkins University in Baltimore who was not involved in the research.

Dr. Crews, who is also president-elect of the American Society of Nephrology noted that the findings “may be a conservative estimate of the cost-effectiveness of CKD screening in certain subgroups, particularly when considering profound racial, ethnic and socioeconomic disparities in survival and CKD progression.”

The USPSTF starts a relook

The new evidence of cost-effectiveness of routine CKD screening follows the USPSTF’s release in January 2023 of a draft research plan to reassess the potential role for CKD screening of asymptomatic adults in the United States, the first step on a potential path to a revised set of recommendations. Public comment on the draft plan closed in February, and based on the standard USPSTF development steps and time frames, a final recommendation statement could appear by early 2026.

Revisiting the prior USPSTF decision from 2012 received endorsement earlier in 2023 from the ASN. The organization issued a statement last January that cited “more than a decade of advocacy in support of more kidney health screening by ASN and other stakeholders dedicated to intervening earlier to slow or stop the progression of kidney diseases.”

A more detailed letter of support for CKD screening sent to top USPSTF officials followed in February 2023 from ASN president Michelle A. Josephson, MD, who said in part that “ASN believes that kidney care is at an inflection point. There are now far more novel therapeutics to slow the progression of CKD, evidence to support the impact of nonpharmacologic interventions on CKD, and an increased commitment in public health to confront disparities and their causes.”
 

USPSTF recommendation could make a difference

Dr. Josephson also cited the modest effect that CKD screening recommendations from other groups have had up to now.

“Although guidance from Kidney Disease Improving Global Outcomes and the National Kidney Foundation recommends CKD screening among patients with hypertension, only approximately 10% of individuals with hypertension receive yearly screening. Furthermore, American Diabetes Association guidelines recommend yearly CKD screening in patients with diabetes, but only 40%-50% of patients receive this.”

“USPSTF recommendations tend to reach clinicians in primary care settings, where screening for diseases most commonly occurs, much more than recommendations from professional or patient organizations,” Dr. Crews said in an interview. “USPSTF recommendations also often influence health policies that might financially incentivize clinicians and health systems to screen their patients.”

“We hope [the USPSTF] will be interested in including our results within the totality of evidence assessed in their review of CKD screening,” said Ms. Cusick.
 

Preventing hundreds of thousands dialysis cases

The Stanford researchers developed a decision analytic Markov cohort model of CKD progression in U.S. adults aged 35 years or older and fit their model to data from the National Health and Nutrition Examination Survey (NHANES). They found that implementing one-time screening and adding SGLT2 inhibitors to treatment of the 158 million U.S. adults 35-75 years old would prevent the need for kidney replacement therapy (dialysis or transplant) in approximately 398,000 people over their lifetimes, representing a 10% decrease in such cases, compared with the status quo. Screening every 10 or 5 years combined with SGLT2 inhibitors would prevent approximately 598,000 or 658,000 people, respectively, from requiring kidney replacement therapy, compared with not screening.

Analysis showed that one-time screening produced an incremental cost-effectiveness ratio of $86,300 per quality-adjusted life-year (QALY) gained when one-time screening occurred in adults when they reached 55 years old. Screening every 10 years until people became 75 years old cost $98,400 per QALY gained for this group when adults were 35 years old, and $89,800 per QALY gained when screening occurred at 65 years old. These QALY costs are less than “commonly used” U.S. thresholds for acceptable cost-effectiveness of $100,000-$150,000 per QALY gained, the authors said.

Ms. Cusick highlighted the advantages of population-level screening for all U.S. adults, including those who are asymptomatic, compared with focusing on adults with risk factors, such as hypertension or diabetes.

“While risk-based screening can be more cost effective in some settings, risk factors are not always known, especially in marginalized and disadvantaged populations. This may lead to disparities in the use of screening and downstream health outcomes that could be avoided through universal screening policies,” she explained.

The study received no commercial funding. Ms. Cusick had no disclosures. Dr. Crews has received research grants from Somatus. Dr. Josephson has been a consultant to Exosome Diagnostics, IMMUCOR, Labcorp, Otsuka, UBC, and Vera Therapeutics, and has an ownership interest in Seagen.

Screening for and treating chronic kidney disease (CKD) in all U.S. adults 35-75 years old is cost effective using a strategy that starts by measuring their urine albumin-creatinine ratio (UACR) followed by confirmatory tests and treatment of confirmed cases with current standard-care medications, according to an analysis published in the Annals of Internal Medicine.

This new evidence may prove important as the U.S. Preventive Services Task Force has begun revisiting its 2012 conclusion that “evidence is insufficient to assess the balance of benefits and harms of routine screening for chronic kidney disease in asymptomatic adults.”

A big difference between 2012 and today has been that sodium-glucose cotransporter 2 (SGLT2) inhibitors arrived on the scene as an important complement to well-established treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. SGLT2 inhibitors have been documented as safe and effective for slowing CKD progression regardless of a person’s diabetes status, and have “dramatically altered” first-line treatment of adults with CKD, wrote the authors of the new study.
 

‘Large population health gains’ from CKD screening

“Given the high prevalence of CKD, even among those without risk factors, low-cost screening combined with effective treatment using SGLT2 inhibitors represent value,” explained Marika M. Cusick, lead author of the report, a PhD student, and a health policy researcher at Stanford (Calif.) University. “Our results show large population health gains can be achieved through CKD screening,” she said in an interview.

“This is a well-designed cost-effectiveness analysis that, importantly, considers newer treatments shown to be effective for slowing progression of CKD. The overall findings are convincing,” commented Deidra C. Crews, MD, a nephrologist and professor at Johns Hopkins University in Baltimore who was not involved in the research.

Dr. Crews, who is also president-elect of the American Society of Nephrology noted that the findings “may be a conservative estimate of the cost-effectiveness of CKD screening in certain subgroups, particularly when considering profound racial, ethnic and socioeconomic disparities in survival and CKD progression.”

The USPSTF starts a relook

The new evidence of cost-effectiveness of routine CKD screening follows the USPSTF’s release in January 2023 of a draft research plan to reassess the potential role for CKD screening of asymptomatic adults in the United States, the first step on a potential path to a revised set of recommendations. Public comment on the draft plan closed in February, and based on the standard USPSTF development steps and time frames, a final recommendation statement could appear by early 2026.

Revisiting the prior USPSTF decision from 2012 received endorsement earlier in 2023 from the ASN. The organization issued a statement last January that cited “more than a decade of advocacy in support of more kidney health screening by ASN and other stakeholders dedicated to intervening earlier to slow or stop the progression of kidney diseases.”

A more detailed letter of support for CKD screening sent to top USPSTF officials followed in February 2023 from ASN president Michelle A. Josephson, MD, who said in part that “ASN believes that kidney care is at an inflection point. There are now far more novel therapeutics to slow the progression of CKD, evidence to support the impact of nonpharmacologic interventions on CKD, and an increased commitment in public health to confront disparities and their causes.”
 

USPSTF recommendation could make a difference

Dr. Josephson also cited the modest effect that CKD screening recommendations from other groups have had up to now.

“Although guidance from Kidney Disease Improving Global Outcomes and the National Kidney Foundation recommends CKD screening among patients with hypertension, only approximately 10% of individuals with hypertension receive yearly screening. Furthermore, American Diabetes Association guidelines recommend yearly CKD screening in patients with diabetes, but only 40%-50% of patients receive this.”

“USPSTF recommendations tend to reach clinicians in primary care settings, where screening for diseases most commonly occurs, much more than recommendations from professional or patient organizations,” Dr. Crews said in an interview. “USPSTF recommendations also often influence health policies that might financially incentivize clinicians and health systems to screen their patients.”

“We hope [the USPSTF] will be interested in including our results within the totality of evidence assessed in their review of CKD screening,” said Ms. Cusick.
 

Preventing hundreds of thousands dialysis cases

The Stanford researchers developed a decision analytic Markov cohort model of CKD progression in U.S. adults aged 35 years or older and fit their model to data from the National Health and Nutrition Examination Survey (NHANES). They found that implementing one-time screening and adding SGLT2 inhibitors to treatment of the 158 million U.S. adults 35-75 years old would prevent the need for kidney replacement therapy (dialysis or transplant) in approximately 398,000 people over their lifetimes, representing a 10% decrease in such cases, compared with the status quo. Screening every 10 or 5 years combined with SGLT2 inhibitors would prevent approximately 598,000 or 658,000 people, respectively, from requiring kidney replacement therapy, compared with not screening.

Analysis showed that one-time screening produced an incremental cost-effectiveness ratio of $86,300 per quality-adjusted life-year (QALY) gained when one-time screening occurred in adults when they reached 55 years old. Screening every 10 years until people became 75 years old cost $98,400 per QALY gained for this group when adults were 35 years old, and $89,800 per QALY gained when screening occurred at 65 years old. These QALY costs are less than “commonly used” U.S. thresholds for acceptable cost-effectiveness of $100,000-$150,000 per QALY gained, the authors said.

Ms. Cusick highlighted the advantages of population-level screening for all U.S. adults, including those who are asymptomatic, compared with focusing on adults with risk factors, such as hypertension or diabetes.

“While risk-based screening can be more cost effective in some settings, risk factors are not always known, especially in marginalized and disadvantaged populations. This may lead to disparities in the use of screening and downstream health outcomes that could be avoided through universal screening policies,” she explained.

The study received no commercial funding. Ms. Cusick had no disclosures. Dr. Crews has received research grants from Somatus. Dr. Josephson has been a consultant to Exosome Diagnostics, IMMUCOR, Labcorp, Otsuka, UBC, and Vera Therapeutics, and has an ownership interest in Seagen.

Patients with arginine vasopressin deficiency (AVD) appear to also be deficient in oxytocin, the “love hormone,” suggesting a possible pathway for treating the psychological symptoms associated with the illness.
 

Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.

It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.

Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.

“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.

“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.

The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.

“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.

“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.

However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.

“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.

In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
 

Eightfold increase in plasma oxytocin levels in patients vs. control persons

The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.

All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.

Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.

In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.

The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).

The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.

The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.

“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.

Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.

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

Patients with arginine vasopressin deficiency (AVD) appear to also be deficient in oxytocin, the “love hormone,” suggesting a possible pathway for treating the psychological symptoms associated with the illness.
 

Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.

It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.

Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.

“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.

“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.

The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.

“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.

“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.

However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.

“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.

In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
 

Eightfold increase in plasma oxytocin levels in patients vs. control persons

The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.

All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.

Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.

In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.

The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).

The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.

The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.

“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.

Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.

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

Patients with arginine vasopressin deficiency (AVD) appear to also be deficient in oxytocin, the “love hormone,” suggesting a possible pathway for treating the psychological symptoms associated with the illness.
 

Formerly known as central diabetes insipidus, AVD is a rare neuroendocrine condition in which fluid isn’t regulated, leading to polydipsia and polyuria. The vasopressin receptor 2 agonist desmopressin treats those symptoms, but patients often also experience psychopathological problems, such as increased anxiety, depression, and emotional withdrawal.

It has been hypothesized that those symptoms are caused by a concurrent deficiency of the so-called “love hormone” oxytocin, given the anatomic proximity of vasopressin and oxytocin production in the brain.

Now, for the first time, researchers have demonstrated evidence of that phenomenon using 3,4-methylenedioxymethamphetamine (MDMA, also known as “ecstasy”) to provoke oxytocin release. In individuals without AVD, use of MDMA resulted in large increases in plasma oxytocin concentrations, whereas there was very little response among those with AVD, suggesting that the latter patients were deficient in oxytocin.

“These findings are suggestive of a new hypothalamic–pituitary disease entity and contribute to deepening our understanding of oxytocin as a key hormone in centrally generated socioemotional effects, as reflected by reduced prosocial, empathic, and anxiolytic effects in patients with an oxytocin deficiency,” Cihan Atila, MD, of the University of Basel (Switzerland), and colleagues wrote.

“Future studies should evaluate whether oxytocin replacement therapy can alleviate residual symptoms related to oxytocin deficiency in patients with [AVD],” they added.

The findings, from a single-center study of 15 patients with AVD and 15 healthy control persons, were published online in The Lancet Diabetes and Endocrinology.

“Atila and colleagues provide compelling evidence for a clinically relevant oxytocin deficiency in this population of patients, which appears to be at least partly responsible for the associated increase in psychopathological findings,” say Mirela Diana Ilie, MD, an endocrinologist in training at the National Institute of Endocrinology, Bucharest, Romania, and Gérald Raverot, MD, professor of endocrinology at Lyon (France) University Hospital, France, in an accompanying editorial.

“From a therapeutic viewpoint, the findings ... pave the way to intervention studies assessing the effect of intranasal oxytocin in patients with [AVD] and better clinical care for these patients,” they add.

However, Dr. Ilie and Dr. Raverot urged caution for a variety of reasons, including the fact that, thus far, only one patient with arginine vasopressin deficiency has been administered oxytocin on a long-term basis. They suggested further studies to answer many pertinent questions, such as what the appropriate doses and frequency of oxytocin administration are, whether the dose should remain constant or be increased during stress or particular acute situations, whether long-term administration is suitable for all patients regardless of the extent of oxytocin deficiency, and how follow-up should be conducted.

“Answering these questions seems all the more important considering that oxytocin therapy has shown conflicting results when administered for psychiatric disorders,” said Dr. Ilie and Dr. Raverot.

In the meantime, “independent of the potential use of oxytocin, given the frequent and important psychological burden of [AVD], clinicians should screen patients for psychological comorbidities and should not hesitate to refer them to appropriate psychological and psychiatric care,” the editorialists wrote.
 

Eightfold increase in plasma oxytocin levels in patients vs. control persons

The 15 AVD patients and 15 matched healthy control persons were recruited between Feb. 1, 2021, and May 1, 2022. Of those with AVD, eight had an isolated posterior pituitary dysfunction, and seven had a combined pituitary dysfunction. The patients had significantly higher scores on measures of anxiety, alexithymia, and depression, and self-reported mental health was lower, compared with control persons.

All participants were randomly assigned to receive either a single oral dose of MDMA 100 mg or placebo in the first experimental session and the opposite treatment in a second session. There was a 2-week washout period in between.

Median oxytocin concentrations at baseline were 77 pg/mL in the healthy control persons and peaked after MDMA stimulation to 624 pg/mL after 180 minutes, with a maximum of 659 pg/mL. In contrast, among the patients with AVD, baseline oxytocin levels were 60 pg/mL and peaked to just 92 pg/mL after 150 minutes, with a maximum change in concentration of 66 pg/mL.

In response to MDMA, there was an eightfold increase in plasma oxytocin area under the curve among the control persons versus no notable increase in the patients with AVD.

The net incremental oxytocin area under the curve after MDMA administration was 82% higher among control persons than patients (P < .0001).

The MDMA-induced increase in oxytocin was associated with reduced anxiety scores among the control persons but not the AVD patients. Similar results were seen for subjective prosocial and empathic effects.

The most frequently reported adverse effects of the MDMA provocation in both groups were fatigue, lack of appetite, and dry mouth, all of which occurred in more than half of participants.

“These findings contradict the previous theory that oxytocin stimulation has only a secondary role in the effects of MDMA. Our results, by contrast, suggest a paradigm shift and underline the importance of oxytocin as a key feature of the effects of MDMA,” Dr. Atila and colleagues concluded.

Dr. Atila, Dr. Ilie, and Dr. Raverot have disclosed no relevant financial relationships. One study coauthor owns stock in MiniMed.

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

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.

“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”

Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.

Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:

• Personal or family history of thyroid disease.
• History of head or neck radiation.
• History of a prior thyroid surgery.
• Over age 30.
• Any autoimmune disease.
• A body mass index greater than 40 kg/m².
• History of pregnancy loss, preterm delivery, or infertility.
• Recently used amiodarone lithium or iodine-based contrast.
• Lived in an area of known iodine deficiency.
• Clinical suspicion of thyroid disease.

ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.

Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).

“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”

The researchers did not find any significant difference in preterm delivery rates.

Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.

In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.

Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
 

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

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

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

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

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

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

DUBLIN – Substantial reductions in body weight across body mass index categories, as well as improved body composition, were achieved with tirzepatide (Mounjaro) in adults for chronic weight management, according to the latest results of the SURMOUNT-1 study.

The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.

Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.

Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.

Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.

“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.

Weight loss and body composition explored

Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization. 

The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m² (class I, II, III obesity) or greater than or equal to 27 kg/m² (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m², and 94.5% of participants had BMI greater than or equal to 30 kg/m².

Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m², greater than or equal to 30 to less than 35 kg/m² (class 1 obesity), greater than or equal to 35 to less than 40 kg/m² (class 2 obesity), and greater than or equal to 40 kg/m² (class 3 obesity).

In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).

The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).

The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.

By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category. 

“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m²,” he explained. “It’s the higher BMI categories where we need the higher dose.”

As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.

“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”

Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported. 

Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.

With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.

“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.

Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.

“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”

“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”

The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.

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

DUBLIN – Substantial reductions in body weight across body mass index categories, as well as improved body composition, were achieved with tirzepatide (Mounjaro) in adults for chronic weight management, according to the latest results of the SURMOUNT-1 study.

The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.

Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.

Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.

Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.

“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.

Weight loss and body composition explored

Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization. 

The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m² (class I, II, III obesity) or greater than or equal to 27 kg/m² (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m², and 94.5% of participants had BMI greater than or equal to 30 kg/m².

Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m², greater than or equal to 30 to less than 35 kg/m² (class 1 obesity), greater than or equal to 35 to less than 40 kg/m² (class 2 obesity), and greater than or equal to 40 kg/m² (class 3 obesity).

In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).

The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).

The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.

By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category. 

“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m²,” he explained. “It’s the higher BMI categories where we need the higher dose.”

As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.

“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”

Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported. 

Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.

With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.

“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.

Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.

“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”

“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”

The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.

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

DUBLIN – Substantial reductions in body weight across body mass index categories, as well as improved body composition, were achieved with tirzepatide (Mounjaro) in adults for chronic weight management, according to the latest results of the SURMOUNT-1 study.

The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.

Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.

Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.

Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.

“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.

Weight loss and body composition explored

Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization. 

The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m² (class I, II, III obesity) or greater than or equal to 27 kg/m² (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m², and 94.5% of participants had BMI greater than or equal to 30 kg/m².

Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m², greater than or equal to 30 to less than 35 kg/m² (class 1 obesity), greater than or equal to 35 to less than 40 kg/m² (class 2 obesity), and greater than or equal to 40 kg/m² (class 3 obesity).

In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).

The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).

The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.

By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category. 

“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m²,” he explained. “It’s the higher BMI categories where we need the higher dose.”

As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.

“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”

Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported. 

Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.

With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.

“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.

Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.

“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”

“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”

The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.

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

DUBLIN – Ear acupuncture with stimulation beads leads to weight loss and a reduction in both waist circumference and body fat percentage, when combined with restricted food intake, in men with high levels of visceral fat and overweight/obesity.

Edward Olive/Dreamstime.com

Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.

According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.

Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.

Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.

“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”

Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”

In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.

The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.

Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.

“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.

The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.

At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m² and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.

After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m² (from 28.4 at baseline to 25.5 at 3 months; P < .001).

Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.

“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.

He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”

Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.

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

DUBLIN – Ear acupuncture with stimulation beads leads to weight loss and a reduction in both waist circumference and body fat percentage, when combined with restricted food intake, in men with high levels of visceral fat and overweight/obesity.

Edward Olive/Dreamstime.com

Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.

According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.

Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.

Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.

“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”

Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”

In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.

The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.

Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.

“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.

The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.

At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m² and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.

After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m² (from 28.4 at baseline to 25.5 at 3 months; P < .001).

Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.

“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.

He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”

Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.

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

DUBLIN – Ear acupuncture with stimulation beads leads to weight loss and a reduction in both waist circumference and body fat percentage, when combined with restricted food intake, in men with high levels of visceral fat and overweight/obesity.

Edward Olive/Dreamstime.com

Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.

According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.

Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.

Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.

“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”

Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”

In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.

The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.

Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.

“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.

The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.

At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m² and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.

After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m² (from 28.4 at baseline to 25.5 at 3 months; P < .001).

Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.

“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.

He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”

Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.

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

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

AURORA, COLO. – Artificial Intelligence has arrived at medical offices, whether or not clinicians feel ready for it.

AI might result in more accurate, efficient, and cost-effective care. But it’s possible it could cause harm. That’s according to Benjamin Collins, MD, at Vanderbilt University Medical Center, Nashville, Tenn., who spoke on the subject at the annual meeting of the Society of General Internal Medicine.

Understanding the nuances of AI is even more important because of the quick development of the algorithms.

“When I submitted this workshop, there was no ChatGPT,” said Dr. Collins, referring to Chat Generative Pre-trained Transformer, a recently released natural language processing model. “A lot has already changed.”
 

Biased data

Biased data are perhaps the biggest pitfall of AI algorithms, Dr. Collins said. If garbage data go in, garbage predictions come out.

If the dataset that trains the algorithm underrepresents a particular gender or ethnic group, for example, the algorithm may not respond accurately to prompts. When an AI tool compounds existing inequalities related to socioeconomic status, ethnicity, or sexual orientation, the algorithm is biased, according to Harvard researchers.

“People often assume that artificial intelligence is free of bias due to the use of scientific processes and its development,” he said. “But whatever flaws exist in data collection and old data can lead to poor representation or underrepresentation in the data used to train the AI tool.”

Racial minorities are underrepresented in studies; therefore, data input into an AI tool might skew results for these patients.

The Framingham Heart Study, for example, which began in 1948, examined heart disease in mainly White participants. The findings from the study resulted in the creation of a sex-specific algorithm that was used to estimate the 10-year cardiovascular risk of a patient. While the cardiovascular risk score was accurate for White persons, it was less accurate for Black patients.

A study published in Science in 2019 revealed bias in an algorithm that used health care costs as a proxy for health needs. Because less money was spent on Black patients who had the same level of need as their White counterparts, the output inaccurately showed that Black patients were healthier and thus did not require extra care.

Developers can also be a source of bias, inasmuch as AI often reflects preexisting human biases, Dr. Collins said.

“Algorithmic bias presents a clear risk of harm that clinicians must play against the benefits of using AI,” Dr. Collins said. “That risk of harm is often disproportionately distributed to marginalized populations.”

As clinicians use AI algorithms to diagnose and detect disease, predict outcomes, and guide treatment, trouble comes when those algorithms perform well for some patients and poorly for others. This gap can exacerbate existing disparities in health care outcomes.

Dr. Collins advised clinicians to push to find out what data were used to train AI algorithms to determine how bias could have influenced the model and whether the developers risk-adjusted for bias. If the training data are not available, clinicians should ask their employers and AI developers to know more about the system.

Clinicians may face the so-called black box phenomenon, which occurs when developers cannot or will not explain what data went into an AI model, Dr. Collins said.

According to Stanford (Calif.) University, AI must be trained on large datasets of images that have been annotated by human experts. Those datasets can cost millions of dollars to create, meaning corporations often fund them and do not always share the data publicly.

Some groups, such as Stanford’s Center for Artificial Intelligence in Medicine and Imaging, are working to acquire annotated datasets so researchers who train AI models can know where the data came from.

Paul Haidet, MD, MPH, an internist at Penn State College of Medicine, Hershey, sees the technology as a tool that requires careful handling.

“It takes a while to learn how to use a stethoscope, and AI is like that,” Dr. Haidet said. “The thing about AI, though, is that it can be just dropped into a system and no one knows how it works.”

Dr. Haidet said he likes knowing how the sausage is made, something AI developers are often reticent to make known.

“If you’re just putting blind faith in a tool, that’s scary,” Dr. Haidet said.
 

Transparency and ‘explainability’

The ability to explain what goes into tools is essential to maintaining trust in the health care system, Dr. Collins said.

“Part of knowing how much trust to place in the system is the transparency of those systems and the ability to audit how well the algorithm is performing,” Dr. Collins said. “The system should also regularly report to users the level of certainty with which it is providing an output rather than providing a simple binary output.”

Dr. Collins recommends that providers develop an understanding of the limits of AI regulations as well, which might including learning how the system was approved and how it is monitored.

“The FDA has oversight over some applications of AI and health care for software as a medical device, but there’s currently no dedicated process to evaluate the systems for the presence of bias,” Dr. Collins said. “The gaps in regulation leave the door open for the use of AI in clinical care that contain significant biases.”

Dr. Haidet likened AI tools to the Global Positioning System: A good GPS system will let users see alternate routes, opt out of toll roads or highways, and will highlight why routes have changed. But users need to understand how to read the map so they can tell when something seems amiss.

Dr. Collins and Dr. Haidet report no relevant financial relationships

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

AURORA, COLO. – How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

AURORA, COLO. – How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

AURORA, COLO. – How often do you talk with patients about how to lower their out-of-pocket costs for medical care?

For most clinicians, the answer is: not often enough. But having those conversations can improve medication adherence and strengthen the patient-clinician relationship, according to panelists at the annual meeting of the Society of General Internal Medicine.

The inverse association between out-of-pocket expenditures and fidelity to prescriptions is clear. A 2020 study by the IQVIA Institute for Human Data Science, for example, found that rates of prescription abandonment are less than 5% when a given medication carries no out-of-pocket cost for patients. That figure rises to 45% when the cost is more than $125, and to 60% when it exceeds $500. One in five Americans said cost prevented them from adhering to medication regimens, according to a new study in JAMA Network Open.

The researchers surveyed more than 2,000 men and women, 40.4% of whom were aged 75 or older. They found that nearly 90% of respondents said they would not be uncomfortable being asked about drug costs before a visit with a physician. A similar share (89.5%) said they would welcome the use by their physician of a real-time tool to determine the cost of their medication.

But the survey results contained a note of warning for clinicians: A significant number of respondents said they would be “extremely” upset if the cost of their medication exceeded the estimate from the pricing tool. And many also said they would be “moderately” or “extremely” angry if their physician used a pricing tool but failed to share the results with them.

“Real-time benefit tools may support medication cost conversations and cost-conscious prescribing, and patients are enthusiastic about their use,” the authors write. “However, if disclosed prices are inaccurate, there is potential for harm through loss of confidence in the physician and nonadherence to prescribed medications.”

While having conversations about cost can be difficult for both clinicians and patients, studies have shown that patients who discuss cost concerns with their doctors feel as if they have stronger relationships as a result.

Clinicians often avoid conversations about out-of-pocket expenses because they don’t know specific price information, they lack solutions to address cost, or they are uncomfortable bringing up the issue.

One member of the audience at the SGIM meeting recalled a patient who worked in a warehouse for a large company. The man, who had type 2 diabetes, had medical insurance, but even with insurance, insulin was going to cost him $150 per month. He struggled to afford the necessary treatment.

“He looked at me and said, ‘What do they want me to do? Do they want me to actually not be able to work for them and not manage my diabetes?’ ”

The clinician said he offered empathy in the moment but felt he could do little else.

Panelists acknowledged that clinicians are crunched on time when seeing patients, but being willing to initiate conversations about cost with patients and to offer resources can help patients get necessary treatment.
 

Start the conversation

Panel member Caroline Sloan, MD, an assistant professor of medicine at Duke University, Durham, N.C., said making patients aware that you know cost can make a big difference.

The American College of Physicians advises clinicians to ask patients whether they are worried about the cost of care and to not assume which patients may have concerns.

The conversation could be started like this: “I’d like to discuss any concerns you might have about the cost of your health care.”

Normalize the concern by making it more general, and reassure your patient that your goal is to get them the best care. Say something like, “I’ve heard from many patients the cost of medications or tests is becoming hard to manage.”

Once a patient’s concerns are clear, you can direct them to resources for assistance in reducing their costs, Dr. Sloan said, such as ClearHealthCosts, FAIR Health, Healthcare Bluebook, New Choice Health, GoodRx, PharmacyChecker, HealthWell Foundation, Patient Advocate Foundation, Good Days, Good Health Will, Mercy Medical Angels, and the American Association of Family Physicians Neighborhood Navigator.

Dr. Sloan said she knows clinicians don’t have time to understand every insurance plan and other issues related to cost. “But at least know to ask about costs,” she said. “Practice, practice, practice. It feels awkward at first, but it gets easier every time.”

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

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

DUBLIN – Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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