Sjögren Subtypes Have Distinct Pathophysiologic Profiles

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TOPLINE:

Sjögren disease (SjD) presents three distinct phenotypes ― B-cell active with low symptom burden, high systemic activity with high symptom burden, and low systemic activity with high symptom burden; each phenotype has unique cytokine profiles and interferon (IFN) signatures, with elevated cytokine levels for T and B lymphocyte activation in the first two groups and a prominent IFN signature in the B-cell active group.

METHODOLOGY:

  • Researchers conducted this study to assess whether three distinct phenotypes of patients with SjD were associated with distinct pathophysiological pathways and IFN signatures.
  • They included 395 patients (median age, 53 years; 94% women) from the Assessment of Systemic Signs and Evolution in Sjögren’s Syndrome (ASSESS) cohort who met the 2002 American-European Consensus Group criteria for SjD.
  • A panel of biomarkers including IFN alpha-2, IFN gamma, CXCL10, CXCL13, B-cell activating factor, interleukin (IL) 7, FLT3, CCL19, and tumor necrosis factor receptor II (TNF-RII) was compared between the three phenotypes.
  • The IFN signature was assessed using whole blood transcriptomic analysis.
  • Analysis compared systemic and symptomatic evolution and assessed the risk for new immunosuppressant prescription and lymphoma development across three clusters on the basis of the IFN signature.

TAKEAWAY:

  • Higher levels of CXCL13, IL-7, and TNF-RII cytokines were found in both the B-cell active and high systemic activity groups than in the low systemic activity group (P < .05 for all).
  • The low systemic activity cluster with reduced cytokine levels showed less disease progression, with no instances of lymphoma reported in this group.
  • A high IFN signature was found in a higher percentage of patients in the B-cell active group (57%) than in the high systemic activity (48%) and low systemic activity (38%) groups.
  • In the B-cell active cluster, this high IFN signature was associated with an increased risk for new immunosuppressant prescription, indicating greater disease progression (hazard ratio, 9.38; P = .0032); also, all cases of lymphoma within this group were found in individuals exhibiting a high IFN signature.

IN PRACTICE:

“Our study demonstrated that our stratification, defined by symptoms, systemic clinical signs, and routine biological data, is based on different pathophysiological pathways, particularly B and T lymphocyte activation and the interferon alpha pathway. The latter could help predict the evolution of the BALS cluster, a biological but minimally symptomatic cluster, to consider closer monitoring and/or early treatments to prevent complications,” the authors wrote.

SOURCE:

The study was led by Yann Nguyen, MD, PhD, Department of Rheumatology, Hôpital Bicêtre, Assistance Publique — Hôpitaux de Paris, Université Paris-Saclay, Paris, France, and was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study evaluated only a few cytokines at the time of inclusion in the ASSESS cohort, which may not have captured the full range of biologic markers relevant to SjD. The evolution of systemic activity defined using the European Alliance of Associations for Rheumatology Sjogren’s Syndrome Disease Activity Index showed no difference according to the IFN signature in the B-cell active with low symptom burden cluster, possibly due to treatments received between annual evaluations.

DISCLOSURES:

The ASSESS cohort is supported by research grants from the French Society of Rheumatology. Some authors reported receiving grants, payments, honoraria, consulting fees, and support for attending meetings and having contracts or other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Sjögren disease (SjD) presents three distinct phenotypes ― B-cell active with low symptom burden, high systemic activity with high symptom burden, and low systemic activity with high symptom burden; each phenotype has unique cytokine profiles and interferon (IFN) signatures, with elevated cytokine levels for T and B lymphocyte activation in the first two groups and a prominent IFN signature in the B-cell active group.

METHODOLOGY:

  • Researchers conducted this study to assess whether three distinct phenotypes of patients with SjD were associated with distinct pathophysiological pathways and IFN signatures.
  • They included 395 patients (median age, 53 years; 94% women) from the Assessment of Systemic Signs and Evolution in Sjögren’s Syndrome (ASSESS) cohort who met the 2002 American-European Consensus Group criteria for SjD.
  • A panel of biomarkers including IFN alpha-2, IFN gamma, CXCL10, CXCL13, B-cell activating factor, interleukin (IL) 7, FLT3, CCL19, and tumor necrosis factor receptor II (TNF-RII) was compared between the three phenotypes.
  • The IFN signature was assessed using whole blood transcriptomic analysis.
  • Analysis compared systemic and symptomatic evolution and assessed the risk for new immunosuppressant prescription and lymphoma development across three clusters on the basis of the IFN signature.

TAKEAWAY:

  • Higher levels of CXCL13, IL-7, and TNF-RII cytokines were found in both the B-cell active and high systemic activity groups than in the low systemic activity group (P < .05 for all).
  • The low systemic activity cluster with reduced cytokine levels showed less disease progression, with no instances of lymphoma reported in this group.
  • A high IFN signature was found in a higher percentage of patients in the B-cell active group (57%) than in the high systemic activity (48%) and low systemic activity (38%) groups.
  • In the B-cell active cluster, this high IFN signature was associated with an increased risk for new immunosuppressant prescription, indicating greater disease progression (hazard ratio, 9.38; P = .0032); also, all cases of lymphoma within this group were found in individuals exhibiting a high IFN signature.

IN PRACTICE:

“Our study demonstrated that our stratification, defined by symptoms, systemic clinical signs, and routine biological data, is based on different pathophysiological pathways, particularly B and T lymphocyte activation and the interferon alpha pathway. The latter could help predict the evolution of the BALS cluster, a biological but minimally symptomatic cluster, to consider closer monitoring and/or early treatments to prevent complications,” the authors wrote.

SOURCE:

The study was led by Yann Nguyen, MD, PhD, Department of Rheumatology, Hôpital Bicêtre, Assistance Publique — Hôpitaux de Paris, Université Paris-Saclay, Paris, France, and was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study evaluated only a few cytokines at the time of inclusion in the ASSESS cohort, which may not have captured the full range of biologic markers relevant to SjD. The evolution of systemic activity defined using the European Alliance of Associations for Rheumatology Sjogren’s Syndrome Disease Activity Index showed no difference according to the IFN signature in the B-cell active with low symptom burden cluster, possibly due to treatments received between annual evaluations.

DISCLOSURES:

The ASSESS cohort is supported by research grants from the French Society of Rheumatology. Some authors reported receiving grants, payments, honoraria, consulting fees, and support for attending meetings and having contracts or other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Sjögren disease (SjD) presents three distinct phenotypes ― B-cell active with low symptom burden, high systemic activity with high symptom burden, and low systemic activity with high symptom burden; each phenotype has unique cytokine profiles and interferon (IFN) signatures, with elevated cytokine levels for T and B lymphocyte activation in the first two groups and a prominent IFN signature in the B-cell active group.

METHODOLOGY:

  • Researchers conducted this study to assess whether three distinct phenotypes of patients with SjD were associated with distinct pathophysiological pathways and IFN signatures.
  • They included 395 patients (median age, 53 years; 94% women) from the Assessment of Systemic Signs and Evolution in Sjögren’s Syndrome (ASSESS) cohort who met the 2002 American-European Consensus Group criteria for SjD.
  • A panel of biomarkers including IFN alpha-2, IFN gamma, CXCL10, CXCL13, B-cell activating factor, interleukin (IL) 7, FLT3, CCL19, and tumor necrosis factor receptor II (TNF-RII) was compared between the three phenotypes.
  • The IFN signature was assessed using whole blood transcriptomic analysis.
  • Analysis compared systemic and symptomatic evolution and assessed the risk for new immunosuppressant prescription and lymphoma development across three clusters on the basis of the IFN signature.

TAKEAWAY:

  • Higher levels of CXCL13, IL-7, and TNF-RII cytokines were found in both the B-cell active and high systemic activity groups than in the low systemic activity group (P < .05 for all).
  • The low systemic activity cluster with reduced cytokine levels showed less disease progression, with no instances of lymphoma reported in this group.
  • A high IFN signature was found in a higher percentage of patients in the B-cell active group (57%) than in the high systemic activity (48%) and low systemic activity (38%) groups.
  • In the B-cell active cluster, this high IFN signature was associated with an increased risk for new immunosuppressant prescription, indicating greater disease progression (hazard ratio, 9.38; P = .0032); also, all cases of lymphoma within this group were found in individuals exhibiting a high IFN signature.

IN PRACTICE:

“Our study demonstrated that our stratification, defined by symptoms, systemic clinical signs, and routine biological data, is based on different pathophysiological pathways, particularly B and T lymphocyte activation and the interferon alpha pathway. The latter could help predict the evolution of the BALS cluster, a biological but minimally symptomatic cluster, to consider closer monitoring and/or early treatments to prevent complications,” the authors wrote.

SOURCE:

The study was led by Yann Nguyen, MD, PhD, Department of Rheumatology, Hôpital Bicêtre, Assistance Publique — Hôpitaux de Paris, Université Paris-Saclay, Paris, France, and was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study evaluated only a few cytokines at the time of inclusion in the ASSESS cohort, which may not have captured the full range of biologic markers relevant to SjD. The evolution of systemic activity defined using the European Alliance of Associations for Rheumatology Sjogren’s Syndrome Disease Activity Index showed no difference according to the IFN signature in the B-cell active with low symptom burden cluster, possibly due to treatments received between annual evaluations.

DISCLOSURES:

The ASSESS cohort is supported by research grants from the French Society of Rheumatology. Some authors reported receiving grants, payments, honoraria, consulting fees, and support for attending meetings and having contracts or other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Early Patching Benefits Kids Born With Cataract in One Eye

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TOPLINE:

Children with congenital cataract in one eye are more likely to achieve nearly normal vision when their caregivers maintain consistent daily patching schedules in the first year after surgery, particularly in the morning or at regular times every day.

METHODOLOGY:

  • Researchers conducted a post hoc analysis of the Infant Aphakia Treatment Study to examine the association between the reported consistency in patching during the first year after unilateral cataract surgery and visual acuity.
  • They included data from 101 children whose caregivers completed 7-day patching diaries at 2 months after surgery or at age 13 months.
  • The treatment protocol required caregivers to have their child wear a patch over the fellow eye for 1 hour daily from the second week after cataract surgery until age 8 months, followed by patching for 50% of waking hours until age 5 years.
  • Consistent patching was defined as daily patching with an average start time before 9 AM or an interquartile range of the first application time of 60 minutes or less.
  • Visual acuity in the treated eye was the primary outcome, assessed at ages 54 + 1 months and 10.5 years; participants with a visual acuity of 20/40 or better were said to have near-normal vision.

TAKEAWAY:

  • Children whose caregivers reported consistent patching patterns demonstrated better average visual acuity at age 54 months than those whose caregivers reported inconsistent patching patterns (mean difference in logMAR visual acuity, 0.55; 95% CI, 0.22-0.87); the results were promising for children aged 10.5 years, as well.
  • Data from the diary completed at age 13 months showed children whose caregivers reported patching before 9 AM or around the same time daily were more likely to achieve near-normal vision at age 54 + 1 months and 10.5 years (relative risk, 3.55; 95% CI, 1.61-7.80, and 2.31; 95% CI, 1.12-4.78, respectively) than those whose caregivers did not report such behavior.
  • Children whose caregivers reported consistent vs inconsistent patching patterns achieved more average daily hours of patching both during the first year (4.82 h vs 3.50 h) and between ages 12 and 48 months (4.96 h vs 3.03 h).

IN PRACTICE:

“This information can be used by healthcare providers to motivate caregivers to develop consistent patching habits. Further, providers can present caregivers with simple advice: Apply the patch every day either first thing in the morning or about the same time every day,” the authors of the study wrote.

SOURCE:

The study was led by Carolyn Drews-Botsch, PhD, MPH, of the Department of Global and Community Health at George Mason University, in Fairfax, Virginia. It was published online in Ophthalmology.

LIMITATIONS:

The diaries covered only 14 days of the first year following surgery, which may not have fully represented patching patterns during other periods. The researchers noted that establishing a routine for patching was particularly challenging for infants aged less than 5 months at the time of the first diary completion as these infants may not yet have established regular sleep and feeding routines. Parents who participated in this trial may have differed from those in routine practice, potentially affecting the generalizability of the findings to general clinical populations.

DISCLOSURES:

This study was supported by the following grants: 1 R21 EY032152, 2 UG1 EY031287, 5 U10 EY013287, 5 UG1 EY02553, and 7 UG1 EY013272. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Children with congenital cataract in one eye are more likely to achieve nearly normal vision when their caregivers maintain consistent daily patching schedules in the first year after surgery, particularly in the morning or at regular times every day.

METHODOLOGY:

  • Researchers conducted a post hoc analysis of the Infant Aphakia Treatment Study to examine the association between the reported consistency in patching during the first year after unilateral cataract surgery and visual acuity.
  • They included data from 101 children whose caregivers completed 7-day patching diaries at 2 months after surgery or at age 13 months.
  • The treatment protocol required caregivers to have their child wear a patch over the fellow eye for 1 hour daily from the second week after cataract surgery until age 8 months, followed by patching for 50% of waking hours until age 5 years.
  • Consistent patching was defined as daily patching with an average start time before 9 AM or an interquartile range of the first application time of 60 minutes or less.
  • Visual acuity in the treated eye was the primary outcome, assessed at ages 54 + 1 months and 10.5 years; participants with a visual acuity of 20/40 or better were said to have near-normal vision.

TAKEAWAY:

  • Children whose caregivers reported consistent patching patterns demonstrated better average visual acuity at age 54 months than those whose caregivers reported inconsistent patching patterns (mean difference in logMAR visual acuity, 0.55; 95% CI, 0.22-0.87); the results were promising for children aged 10.5 years, as well.
  • Data from the diary completed at age 13 months showed children whose caregivers reported patching before 9 AM or around the same time daily were more likely to achieve near-normal vision at age 54 + 1 months and 10.5 years (relative risk, 3.55; 95% CI, 1.61-7.80, and 2.31; 95% CI, 1.12-4.78, respectively) than those whose caregivers did not report such behavior.
  • Children whose caregivers reported consistent vs inconsistent patching patterns achieved more average daily hours of patching both during the first year (4.82 h vs 3.50 h) and between ages 12 and 48 months (4.96 h vs 3.03 h).

IN PRACTICE:

“This information can be used by healthcare providers to motivate caregivers to develop consistent patching habits. Further, providers can present caregivers with simple advice: Apply the patch every day either first thing in the morning or about the same time every day,” the authors of the study wrote.

SOURCE:

The study was led by Carolyn Drews-Botsch, PhD, MPH, of the Department of Global and Community Health at George Mason University, in Fairfax, Virginia. It was published online in Ophthalmology.

LIMITATIONS:

The diaries covered only 14 days of the first year following surgery, which may not have fully represented patching patterns during other periods. The researchers noted that establishing a routine for patching was particularly challenging for infants aged less than 5 months at the time of the first diary completion as these infants may not yet have established regular sleep and feeding routines. Parents who participated in this trial may have differed from those in routine practice, potentially affecting the generalizability of the findings to general clinical populations.

DISCLOSURES:

This study was supported by the following grants: 1 R21 EY032152, 2 UG1 EY031287, 5 U10 EY013287, 5 UG1 EY02553, and 7 UG1 EY013272. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Children with congenital cataract in one eye are more likely to achieve nearly normal vision when their caregivers maintain consistent daily patching schedules in the first year after surgery, particularly in the morning or at regular times every day.

METHODOLOGY:

  • Researchers conducted a post hoc analysis of the Infant Aphakia Treatment Study to examine the association between the reported consistency in patching during the first year after unilateral cataract surgery and visual acuity.
  • They included data from 101 children whose caregivers completed 7-day patching diaries at 2 months after surgery or at age 13 months.
  • The treatment protocol required caregivers to have their child wear a patch over the fellow eye for 1 hour daily from the second week after cataract surgery until age 8 months, followed by patching for 50% of waking hours until age 5 years.
  • Consistent patching was defined as daily patching with an average start time before 9 AM or an interquartile range of the first application time of 60 minutes or less.
  • Visual acuity in the treated eye was the primary outcome, assessed at ages 54 + 1 months and 10.5 years; participants with a visual acuity of 20/40 or better were said to have near-normal vision.

TAKEAWAY:

  • Children whose caregivers reported consistent patching patterns demonstrated better average visual acuity at age 54 months than those whose caregivers reported inconsistent patching patterns (mean difference in logMAR visual acuity, 0.55; 95% CI, 0.22-0.87); the results were promising for children aged 10.5 years, as well.
  • Data from the diary completed at age 13 months showed children whose caregivers reported patching before 9 AM or around the same time daily were more likely to achieve near-normal vision at age 54 + 1 months and 10.5 years (relative risk, 3.55; 95% CI, 1.61-7.80, and 2.31; 95% CI, 1.12-4.78, respectively) than those whose caregivers did not report such behavior.
  • Children whose caregivers reported consistent vs inconsistent patching patterns achieved more average daily hours of patching both during the first year (4.82 h vs 3.50 h) and between ages 12 and 48 months (4.96 h vs 3.03 h).

IN PRACTICE:

“This information can be used by healthcare providers to motivate caregivers to develop consistent patching habits. Further, providers can present caregivers with simple advice: Apply the patch every day either first thing in the morning or about the same time every day,” the authors of the study wrote.

SOURCE:

The study was led by Carolyn Drews-Botsch, PhD, MPH, of the Department of Global and Community Health at George Mason University, in Fairfax, Virginia. It was published online in Ophthalmology.

LIMITATIONS:

The diaries covered only 14 days of the first year following surgery, which may not have fully represented patching patterns during other periods. The researchers noted that establishing a routine for patching was particularly challenging for infants aged less than 5 months at the time of the first diary completion as these infants may not yet have established regular sleep and feeding routines. Parents who participated in this trial may have differed from those in routine practice, potentially affecting the generalizability of the findings to general clinical populations.

DISCLOSURES:

This study was supported by the following grants: 1 R21 EY032152, 2 UG1 EY031287, 5 U10 EY013287, 5 UG1 EY02553, and 7 UG1 EY013272. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Dry January: Should Doctors Make It Year-Round?

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For millennia in medicine, alcohol, particularly red wine, carried a health halo; in small doses, it has historically been thought to have cardioprotective benefits. Michael Farkouh, MD, a professor of cardiology at Cedars-Sinai, estimates half the physicians still accept people having a drink or two a day. “That is still in practice, though the numbers are reducing,” he said.

But Farkouh no longer drinks alcohol, a position he has come to after getting more involved in research into the substance and his realization that many of the studies touting alcohol’s health benefits were flawed.

Today, alcohol sits alongside asbestos and tobacco as class 1 carcinogens. According to the World Health Organization, it has no known safe ingestible amount. In 2018, a blockbuster report in The Lancet found no amount of any kind of alcohol improves health. In early January, US Surgeon General Vivek Murthy called for adding cancer warnings to alcohol labels.

But the way doctors drink is far from black and white. For physicians, drinking habits are tied up in personal values, professional understanding of a substance with a confusing research history, and the fact alcohol is deeply ingrained in the social fabric of society — and in medicine. As thinking on alcohol shifts, this news organization spoke with physicians about their own drinking habits, how they counsel patients on it, and alcohol’s place in a field that works to keep people healthy.

 

Cultural Currency

From the days of Hippocrates, who believed alcohol could cure virtually every ailment, alcohol has held a large role in medicine. Through much of the 19th century, patent remedies like Hamlin’s Wizard Oil and the Seven Sutherland Sisters Hair Grower, contained alcohol — sometimes in concentrations exceeding 50%.

The first American Pharmacopoeia, published in 1820, even contained nine wine-based medicines. Throughout the second half of the 19th century, physicians largely debated alcohol’s role in medicine. However, a 1922 poll of members of the American Medical Association found that physicians were still using alcohol as a medicine for everything from heart attacks to animal bites.

Today, alcohol’s presence in medicine is, in some ways, representative of a realized cognitive dissonance.

“In my mind, alcohol has completely lost any illusion of benefit. It is a poison to almost every single organ in our body. Yet I’m currently engaged in a duel of being a physician who drinks in moderation and constantly judging myself for it,” said Tyra Fainstad, MD, an internist and an associate professor at CU Medicine in Denver.

Fainstad said every academic national conference she has attended has had a reception with multiple cash bars — and professional recruitment dinners regularly include at least the offering of alcohol. Private hospitals often have open bars at events.

“Drinking has historically been a way that people unwind, even in medicine,” said addiction psychiatrist Alexis Ritvo, MD. Ritvo — who said she drinks occasionally but much less than she used to after paying attention to how alcohol makes her feel and the harm alcohol can cause — noted that some occasions where alcohol is present socially in medicine don’t bother her. Alcohol is even an option at the addiction psychiatry conference, where attendees can exchange tickets for drinks. But last year, the event provided separate bars for alcoholic and nonalcoholic drinks.

“Our life is full of things that are contradictory or at odds,” Ritvo said. “We want things to either be wrong or right, appropriate or inappropriate, but just like all things, everything’s pretty nuanced.”

But there are examples of alcohol being a part of an event that are downright inappropriate, such as when she attended a fundraiser for a recovery facility that had an open bar.

Farkouh said alcohol at events can exclude others. (He recommends that instead of calling a social gathering “going out for drinks,” someone might say, “We’re getting together.”) He drinks mocktails or nonalcoholic beer at work events where alcohol is served.

Brian Dwinnell, MD, associate dean of student life at CU Medicine, said alcohol can quickly become the focus of an event — something he noticed at an annual kickball game between first- and second-year students that has historically served beer.

In recent years, school leadership has removed alcohol from his institution’s match day celebration and the kickball game. “Initially, there was some pushback from students,” he said of making these events dry, “but now, it’s just sort of accepted, and the events have been just as great as they were when we did provide alcohol.”

 

How Doctors Drink

Physicians may have a greater understanding of alcohol’s health harms. Still, they don’t necessarily drink less because of it, and whether they should becomes a question not just of health but also of the standards to which society holds medical professionals.

Data suggest physicians tend to drink at rates similar to those among the general population. A recent Medscape Medical News survey found nearly 60% of physicians have started drinking less.

Dwinnell said he is a long-time “wine connoisseur” and drinks on occasion. But he admitted that while he thinks about the health implications of alcohol more — and he has nixed it from various events for medical students — he does not believe his drinking habits have changed much.

Navya Mysore, MD, a family physician in New York City, said she has become interested in wine over the past few years, even taking classes to learn more about it. “I like understanding how it’s made, the regions it’s from, and how to pair it with food,” she said. Mysore admits she drank a little more than usual throughout the pandemic, yet today, she said her relationship with alcohol in moderation is related to family, community, and connection.

Fainstad, who drinks socially, said: “I think there’s an immeasurable quality to the social ritual of it. I think for better or worse — probably for worse — for many generations, alcohol has been a part of many meaningful traditions and rituals that we hold.”

Farkouh was quick to underscore the importance of social connection, and that alcohol reduces stress for some people. “I don’t want to take that away from people,” he said. But he also stated the importance of finding other ways to find social fulfillment and enjoyment — and said it’s essential for societal norms to shift to reflect this.

With emerging data, alcohol’s image in society is shifting. Ireland recently became the first country to pass regulation requiring all alcohol sold there to come with a cancer warning. All the clinicians interviewed for this article spoke about the increased acceptability of choosing not to drink for whatever reason.

In the context of alcohol, Dwinnell often asks his students, “What if you were out at a restaurant and you saw your mother’s surgeon there and they were intoxicated? Are you going to feel comfortable with that individual operating on your mother tomorrow or any time?” He added: “Physicians are held to a higher professional standard than those in other fields — and they should be. This is a high-stakes business.”

Dwinnell’s hypothetical question to students is a good one, albeit perhaps not always a fair one. “It’s important for people to realize that physicians are humans,” Mysore said. “We are people, we have lives, and we may choose to have habits that are not necessarily the healthiest for us.”

Fainstad said there’s no shame in medical professionals drinking on occasion. “You can’t be held accountable for something you don’t know about,” she said, acknowledging the known harms of alcohol and that there is still more to learn. But she does wonder how doctors who drank might be perceived in years to come. “I can imagine in a couple of decades, people could say, ‘Even doctors used to have a glass of wine with dinner.’”

 

‘Physicians Should Tighten Their Stances on Alcohol’

The 2020-2025 Dietary Guidelines suggest limiting intake to two alcoholic drinks or less daily for men and one drink or less for women or to choose not to drink. Farkouh said he skews toward the latter, encouraging patients to drink as little as possible or nothing at all. “If you take a holistic approach, physicians should tighten their stances on alcohol,” he said.

Ultimately, he said a randomized trial is warranted to address the risk for cardiovascular disease, in particular.

Of course, physicians vary in how they discuss the topic with patients.

Mysore said she regularly educates patients about pour size and ways to swap out alcoholic drinks with nonalcoholic ones. Outside of cases of addiction, she favors the idea of moderation. “I don’t really subscribe to all-or-nothing mindsets. If there’s something that you enjoy having as a part of your life, I don’t think there’s any reason why you need to eliminate it,” she said. “You just need to figure out what moderation looks like for you.”

Ritvo favors motivational interviewing and tries to understand someone’s relationship with alcohol.

Fainstad provides the Dietary Guidelines’ cutoffs to patients and educates them on the poisonous nature of the substance.

Clearer guidance from large governing bodies — potential changes around alcohol in the 2025-230 revision of the US Dietary Guidelines or cancer warnings on booze sold in the United States — are coming and could help streamline messaging.

And although he speaks with urgency about alcohol’s dangers, Farkouh emphasized the need for a judgment-free and patient-centered approach to conversations around drinking: “People have grown up with alcohol being acceptable, and it’s going to take time to change that.”

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

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For millennia in medicine, alcohol, particularly red wine, carried a health halo; in small doses, it has historically been thought to have cardioprotective benefits. Michael Farkouh, MD, a professor of cardiology at Cedars-Sinai, estimates half the physicians still accept people having a drink or two a day. “That is still in practice, though the numbers are reducing,” he said.

But Farkouh no longer drinks alcohol, a position he has come to after getting more involved in research into the substance and his realization that many of the studies touting alcohol’s health benefits were flawed.

Today, alcohol sits alongside asbestos and tobacco as class 1 carcinogens. According to the World Health Organization, it has no known safe ingestible amount. In 2018, a blockbuster report in The Lancet found no amount of any kind of alcohol improves health. In early January, US Surgeon General Vivek Murthy called for adding cancer warnings to alcohol labels.

But the way doctors drink is far from black and white. For physicians, drinking habits are tied up in personal values, professional understanding of a substance with a confusing research history, and the fact alcohol is deeply ingrained in the social fabric of society — and in medicine. As thinking on alcohol shifts, this news organization spoke with physicians about their own drinking habits, how they counsel patients on it, and alcohol’s place in a field that works to keep people healthy.

 

Cultural Currency

From the days of Hippocrates, who believed alcohol could cure virtually every ailment, alcohol has held a large role in medicine. Through much of the 19th century, patent remedies like Hamlin’s Wizard Oil and the Seven Sutherland Sisters Hair Grower, contained alcohol — sometimes in concentrations exceeding 50%.

The first American Pharmacopoeia, published in 1820, even contained nine wine-based medicines. Throughout the second half of the 19th century, physicians largely debated alcohol’s role in medicine. However, a 1922 poll of members of the American Medical Association found that physicians were still using alcohol as a medicine for everything from heart attacks to animal bites.

Today, alcohol’s presence in medicine is, in some ways, representative of a realized cognitive dissonance.

“In my mind, alcohol has completely lost any illusion of benefit. It is a poison to almost every single organ in our body. Yet I’m currently engaged in a duel of being a physician who drinks in moderation and constantly judging myself for it,” said Tyra Fainstad, MD, an internist and an associate professor at CU Medicine in Denver.

Fainstad said every academic national conference she has attended has had a reception with multiple cash bars — and professional recruitment dinners regularly include at least the offering of alcohol. Private hospitals often have open bars at events.

“Drinking has historically been a way that people unwind, even in medicine,” said addiction psychiatrist Alexis Ritvo, MD. Ritvo — who said she drinks occasionally but much less than she used to after paying attention to how alcohol makes her feel and the harm alcohol can cause — noted that some occasions where alcohol is present socially in medicine don’t bother her. Alcohol is even an option at the addiction psychiatry conference, where attendees can exchange tickets for drinks. But last year, the event provided separate bars for alcoholic and nonalcoholic drinks.

“Our life is full of things that are contradictory or at odds,” Ritvo said. “We want things to either be wrong or right, appropriate or inappropriate, but just like all things, everything’s pretty nuanced.”

But there are examples of alcohol being a part of an event that are downright inappropriate, such as when she attended a fundraiser for a recovery facility that had an open bar.

Farkouh said alcohol at events can exclude others. (He recommends that instead of calling a social gathering “going out for drinks,” someone might say, “We’re getting together.”) He drinks mocktails or nonalcoholic beer at work events where alcohol is served.

Brian Dwinnell, MD, associate dean of student life at CU Medicine, said alcohol can quickly become the focus of an event — something he noticed at an annual kickball game between first- and second-year students that has historically served beer.

In recent years, school leadership has removed alcohol from his institution’s match day celebration and the kickball game. “Initially, there was some pushback from students,” he said of making these events dry, “but now, it’s just sort of accepted, and the events have been just as great as they were when we did provide alcohol.”

 

How Doctors Drink

Physicians may have a greater understanding of alcohol’s health harms. Still, they don’t necessarily drink less because of it, and whether they should becomes a question not just of health but also of the standards to which society holds medical professionals.

Data suggest physicians tend to drink at rates similar to those among the general population. A recent Medscape Medical News survey found nearly 60% of physicians have started drinking less.

Dwinnell said he is a long-time “wine connoisseur” and drinks on occasion. But he admitted that while he thinks about the health implications of alcohol more — and he has nixed it from various events for medical students — he does not believe his drinking habits have changed much.

Navya Mysore, MD, a family physician in New York City, said she has become interested in wine over the past few years, even taking classes to learn more about it. “I like understanding how it’s made, the regions it’s from, and how to pair it with food,” she said. Mysore admits she drank a little more than usual throughout the pandemic, yet today, she said her relationship with alcohol in moderation is related to family, community, and connection.

Fainstad, who drinks socially, said: “I think there’s an immeasurable quality to the social ritual of it. I think for better or worse — probably for worse — for many generations, alcohol has been a part of many meaningful traditions and rituals that we hold.”

Farkouh was quick to underscore the importance of social connection, and that alcohol reduces stress for some people. “I don’t want to take that away from people,” he said. But he also stated the importance of finding other ways to find social fulfillment and enjoyment — and said it’s essential for societal norms to shift to reflect this.

With emerging data, alcohol’s image in society is shifting. Ireland recently became the first country to pass regulation requiring all alcohol sold there to come with a cancer warning. All the clinicians interviewed for this article spoke about the increased acceptability of choosing not to drink for whatever reason.

In the context of alcohol, Dwinnell often asks his students, “What if you were out at a restaurant and you saw your mother’s surgeon there and they were intoxicated? Are you going to feel comfortable with that individual operating on your mother tomorrow or any time?” He added: “Physicians are held to a higher professional standard than those in other fields — and they should be. This is a high-stakes business.”

Dwinnell’s hypothetical question to students is a good one, albeit perhaps not always a fair one. “It’s important for people to realize that physicians are humans,” Mysore said. “We are people, we have lives, and we may choose to have habits that are not necessarily the healthiest for us.”

Fainstad said there’s no shame in medical professionals drinking on occasion. “You can’t be held accountable for something you don’t know about,” she said, acknowledging the known harms of alcohol and that there is still more to learn. But she does wonder how doctors who drank might be perceived in years to come. “I can imagine in a couple of decades, people could say, ‘Even doctors used to have a glass of wine with dinner.’”

 

‘Physicians Should Tighten Their Stances on Alcohol’

The 2020-2025 Dietary Guidelines suggest limiting intake to two alcoholic drinks or less daily for men and one drink or less for women or to choose not to drink. Farkouh said he skews toward the latter, encouraging patients to drink as little as possible or nothing at all. “If you take a holistic approach, physicians should tighten their stances on alcohol,” he said.

Ultimately, he said a randomized trial is warranted to address the risk for cardiovascular disease, in particular.

Of course, physicians vary in how they discuss the topic with patients.

Mysore said she regularly educates patients about pour size and ways to swap out alcoholic drinks with nonalcoholic ones. Outside of cases of addiction, she favors the idea of moderation. “I don’t really subscribe to all-or-nothing mindsets. If there’s something that you enjoy having as a part of your life, I don’t think there’s any reason why you need to eliminate it,” she said. “You just need to figure out what moderation looks like for you.”

Ritvo favors motivational interviewing and tries to understand someone’s relationship with alcohol.

Fainstad provides the Dietary Guidelines’ cutoffs to patients and educates them on the poisonous nature of the substance.

Clearer guidance from large governing bodies — potential changes around alcohol in the 2025-230 revision of the US Dietary Guidelines or cancer warnings on booze sold in the United States — are coming and could help streamline messaging.

And although he speaks with urgency about alcohol’s dangers, Farkouh emphasized the need for a judgment-free and patient-centered approach to conversations around drinking: “People have grown up with alcohol being acceptable, and it’s going to take time to change that.”

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

For millennia in medicine, alcohol, particularly red wine, carried a health halo; in small doses, it has historically been thought to have cardioprotective benefits. Michael Farkouh, MD, a professor of cardiology at Cedars-Sinai, estimates half the physicians still accept people having a drink or two a day. “That is still in practice, though the numbers are reducing,” he said.

But Farkouh no longer drinks alcohol, a position he has come to after getting more involved in research into the substance and his realization that many of the studies touting alcohol’s health benefits were flawed.

Today, alcohol sits alongside asbestos and tobacco as class 1 carcinogens. According to the World Health Organization, it has no known safe ingestible amount. In 2018, a blockbuster report in The Lancet found no amount of any kind of alcohol improves health. In early January, US Surgeon General Vivek Murthy called for adding cancer warnings to alcohol labels.

But the way doctors drink is far from black and white. For physicians, drinking habits are tied up in personal values, professional understanding of a substance with a confusing research history, and the fact alcohol is deeply ingrained in the social fabric of society — and in medicine. As thinking on alcohol shifts, this news organization spoke with physicians about their own drinking habits, how they counsel patients on it, and alcohol’s place in a field that works to keep people healthy.

 

Cultural Currency

From the days of Hippocrates, who believed alcohol could cure virtually every ailment, alcohol has held a large role in medicine. Through much of the 19th century, patent remedies like Hamlin’s Wizard Oil and the Seven Sutherland Sisters Hair Grower, contained alcohol — sometimes in concentrations exceeding 50%.

The first American Pharmacopoeia, published in 1820, even contained nine wine-based medicines. Throughout the second half of the 19th century, physicians largely debated alcohol’s role in medicine. However, a 1922 poll of members of the American Medical Association found that physicians were still using alcohol as a medicine for everything from heart attacks to animal bites.

Today, alcohol’s presence in medicine is, in some ways, representative of a realized cognitive dissonance.

“In my mind, alcohol has completely lost any illusion of benefit. It is a poison to almost every single organ in our body. Yet I’m currently engaged in a duel of being a physician who drinks in moderation and constantly judging myself for it,” said Tyra Fainstad, MD, an internist and an associate professor at CU Medicine in Denver.

Fainstad said every academic national conference she has attended has had a reception with multiple cash bars — and professional recruitment dinners regularly include at least the offering of alcohol. Private hospitals often have open bars at events.

“Drinking has historically been a way that people unwind, even in medicine,” said addiction psychiatrist Alexis Ritvo, MD. Ritvo — who said she drinks occasionally but much less than she used to after paying attention to how alcohol makes her feel and the harm alcohol can cause — noted that some occasions where alcohol is present socially in medicine don’t bother her. Alcohol is even an option at the addiction psychiatry conference, where attendees can exchange tickets for drinks. But last year, the event provided separate bars for alcoholic and nonalcoholic drinks.

“Our life is full of things that are contradictory or at odds,” Ritvo said. “We want things to either be wrong or right, appropriate or inappropriate, but just like all things, everything’s pretty nuanced.”

But there are examples of alcohol being a part of an event that are downright inappropriate, such as when she attended a fundraiser for a recovery facility that had an open bar.

Farkouh said alcohol at events can exclude others. (He recommends that instead of calling a social gathering “going out for drinks,” someone might say, “We’re getting together.”) He drinks mocktails or nonalcoholic beer at work events where alcohol is served.

Brian Dwinnell, MD, associate dean of student life at CU Medicine, said alcohol can quickly become the focus of an event — something he noticed at an annual kickball game between first- and second-year students that has historically served beer.

In recent years, school leadership has removed alcohol from his institution’s match day celebration and the kickball game. “Initially, there was some pushback from students,” he said of making these events dry, “but now, it’s just sort of accepted, and the events have been just as great as they were when we did provide alcohol.”

 

How Doctors Drink

Physicians may have a greater understanding of alcohol’s health harms. Still, they don’t necessarily drink less because of it, and whether they should becomes a question not just of health but also of the standards to which society holds medical professionals.

Data suggest physicians tend to drink at rates similar to those among the general population. A recent Medscape Medical News survey found nearly 60% of physicians have started drinking less.

Dwinnell said he is a long-time “wine connoisseur” and drinks on occasion. But he admitted that while he thinks about the health implications of alcohol more — and he has nixed it from various events for medical students — he does not believe his drinking habits have changed much.

Navya Mysore, MD, a family physician in New York City, said she has become interested in wine over the past few years, even taking classes to learn more about it. “I like understanding how it’s made, the regions it’s from, and how to pair it with food,” she said. Mysore admits she drank a little more than usual throughout the pandemic, yet today, she said her relationship with alcohol in moderation is related to family, community, and connection.

Fainstad, who drinks socially, said: “I think there’s an immeasurable quality to the social ritual of it. I think for better or worse — probably for worse — for many generations, alcohol has been a part of many meaningful traditions and rituals that we hold.”

Farkouh was quick to underscore the importance of social connection, and that alcohol reduces stress for some people. “I don’t want to take that away from people,” he said. But he also stated the importance of finding other ways to find social fulfillment and enjoyment — and said it’s essential for societal norms to shift to reflect this.

With emerging data, alcohol’s image in society is shifting. Ireland recently became the first country to pass regulation requiring all alcohol sold there to come with a cancer warning. All the clinicians interviewed for this article spoke about the increased acceptability of choosing not to drink for whatever reason.

In the context of alcohol, Dwinnell often asks his students, “What if you were out at a restaurant and you saw your mother’s surgeon there and they were intoxicated? Are you going to feel comfortable with that individual operating on your mother tomorrow or any time?” He added: “Physicians are held to a higher professional standard than those in other fields — and they should be. This is a high-stakes business.”

Dwinnell’s hypothetical question to students is a good one, albeit perhaps not always a fair one. “It’s important for people to realize that physicians are humans,” Mysore said. “We are people, we have lives, and we may choose to have habits that are not necessarily the healthiest for us.”

Fainstad said there’s no shame in medical professionals drinking on occasion. “You can’t be held accountable for something you don’t know about,” she said, acknowledging the known harms of alcohol and that there is still more to learn. But she does wonder how doctors who drank might be perceived in years to come. “I can imagine in a couple of decades, people could say, ‘Even doctors used to have a glass of wine with dinner.’”

 

‘Physicians Should Tighten Their Stances on Alcohol’

The 2020-2025 Dietary Guidelines suggest limiting intake to two alcoholic drinks or less daily for men and one drink or less for women or to choose not to drink. Farkouh said he skews toward the latter, encouraging patients to drink as little as possible or nothing at all. “If you take a holistic approach, physicians should tighten their stances on alcohol,” he said.

Ultimately, he said a randomized trial is warranted to address the risk for cardiovascular disease, in particular.

Of course, physicians vary in how they discuss the topic with patients.

Mysore said she regularly educates patients about pour size and ways to swap out alcoholic drinks with nonalcoholic ones. Outside of cases of addiction, she favors the idea of moderation. “I don’t really subscribe to all-or-nothing mindsets. If there’s something that you enjoy having as a part of your life, I don’t think there’s any reason why you need to eliminate it,” she said. “You just need to figure out what moderation looks like for you.”

Ritvo favors motivational interviewing and tries to understand someone’s relationship with alcohol.

Fainstad provides the Dietary Guidelines’ cutoffs to patients and educates them on the poisonous nature of the substance.

Clearer guidance from large governing bodies — potential changes around alcohol in the 2025-230 revision of the US Dietary Guidelines or cancer warnings on booze sold in the United States — are coming and could help streamline messaging.

And although he speaks with urgency about alcohol’s dangers, Farkouh emphasized the need for a judgment-free and patient-centered approach to conversations around drinking: “People have grown up with alcohol being acceptable, and it’s going to take time to change that.”

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

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PSMA-PET Detects Metastatic Disease in Prostate Cancer Patients With Negative Conventional Imaging

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TOPLINE: 

Prostate-specific membrane antigen (PSMA)–PET detected metastatic disease in 46% of patients with high-risk prostate cancer previously classified as nonmetastatic by conventional imaging. Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.

METHODOLOGY:

  • Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
  • A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
  • Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
  • Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.

TAKEAWAY:

  • PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
  • Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
  • Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
  • According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.

IN PRACTICE:

“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”

SOURCE:

This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.

LIMITATIONS:

The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.

DISCLOSURES:

Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

Prostate-specific membrane antigen (PSMA)–PET detected metastatic disease in 46% of patients with high-risk prostate cancer previously classified as nonmetastatic by conventional imaging. Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.

METHODOLOGY:

  • Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
  • A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
  • Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
  • Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.

TAKEAWAY:

  • PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
  • Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
  • Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
  • According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.

IN PRACTICE:

“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”

SOURCE:

This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.

LIMITATIONS:

The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.

DISCLOSURES:

Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Prostate-specific membrane antigen (PSMA)–PET detected metastatic disease in 46% of patients with high-risk prostate cancer previously classified as nonmetastatic by conventional imaging. Results were positive in 84% of patients, with polymetastatic disease found in 24% of cases.

METHODOLOGY:

  • Recurrent nonmetastatic hormone-sensitive prostate cancer is characterized by increasing prostate-specific antigen (PSA) levels while naive or responsive to androgen deprivation therapy, without evidence of metastasis on conventional imaging.
  • A post hoc, retrospective, cross-sectional analysis included 182 patients from four prospective studies conducted from September 2016 to September 2021, with participants having recurrent prostate cancer after radical prostatectomy, definitive radiotherapy, or salvage radiotherapy.
  • Inclusion criteria encompassed PSA levels > 1.0 ng/mL after radical prostatectomy and salvage radiotherapy or > 2.0 ng/mL above nadir after definitive radiotherapy, PSA doubling time ≤ 9 months, and serum testosterone ≥ 150 ng/dL.
  • Researchers at the University of California, Los Angeles, performed Gallium-68-PSMA-11 PET/CT imaging with a median injection of 5.0 mCi and uptake time of 61 minutes, with 98% of patients receiving CT contrast.

TAKEAWAY:

  • PSMA-PET findings were positive in 80% of patients after radical prostatectomy, 92% after definitive radiotherapy, 85% after radical prostatectomy and salvage radiotherapy, and 84% overall (153 of 182 patients).
  • Distant metastatic disease was detected in 34% of patients after radical prostatectomy, 56% after definitive radiotherapy, 60% after radical prostatectomy and salvage radiotherapy, and 46% overall.
  • Polymetastatic disease (≥ 5 lesions) was identified in 19% of patients after radical prostatectomy, 36% after definitive radiotherapy, 23% after radical prostatectomy and salvage radiotherapy, and 24% overall.
  • According to the authors, these findings suggest that patients’ high-risk nonmetastatic hormone-sensitive prostate cancers are understaged by conventional imaging.

IN PRACTICE:

“In a cohort of patients with high-risk hormone-sensitive prostate cancer without evidence of metastatic disease by conventional imaging, PSMA-PET results were positive in 84% of patients, detected M1 disease stage in 46% of patients, and found polymetastatic disease in 24% of patients. ... The results challenge the interpretation of previous studies, such as the EMBARK trial, and support the evolving role of PSMA-PET for patient selection in clinical and trial interventions in prostate cancer,” the authors of the new paper wrote. “Further studies are needed to assess its independent prognostic value and use for treatment guidance.”

SOURCE:

This study was led by Adrien Holzgreve, MD, and Wesley R. Armstrong, BS, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles. It was published online on January 3 in JAMA Network Open.

LIMITATIONS:

The analysis included significantly fewer patients treated with combined radical prostatectomy and salvage radiotherapy than the original EMBARK trial (29% vs 49%). Patients in this study had a lower median PSA doubling time and serum PSA level at enrollment than those in the EMBARK study. The retrospective nature of this study precluded systematic baseline imaging that would be standard for clinical trial enrollment. Additionally, while PSMA-PET offers the best diagnostic accuracy for prostate cancer staging, it can produce false-positive findings, particularly in bone metastases, with a positive predictive value of 0.84% in biochemical recurrence.

DISCLOSURES:

Holzgreve reported receiving personal fees from ABX advanced biochemical compounds outside the submitted work. This study was supported by grants from the Deutsche Forschungsgemeinschaft, the Prostate Cancer Foundation, and the Society of Nuclear Medicine and Molecular Imaging. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Retatrutide Produces Greatest Weight Loss

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A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

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A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

A systematic review of 26 randomized controlled trials (RCTs) finds that, among glucagon-like peptide 1 (GLP-1) receptor agonists and co-agonists on the market or still being investigated, the experimental drug retatrutide (Eli Lilly) produces the greatest weight loss.

The review, conducted by researchers at McGill University, Montreal, Quebec, Canada, examined three commercially available medications in the class and nine that have not yet received regulatory approval.

In healthy adults with overweight or obesity who did not have diabetes, the highest mean reductions in relative and absolute body weight were achieved with once-weekly triple glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 and glucagon receptor agonist retatrutide, followed by the dual GIP/GLP-1 agonist tirzepatide (Eli Lilly) and lastly by the GLP-1 agonist semaglutide (Novo Nordisk), according to the authors.

The use of all the GLP-1s or co-agonist medications “led to decreased body mass index (BMI), waist circumference, SBP (systolic blood pressure), and DBP (diastolic blood pressure),” wrote the authors in Annals of Internal Medicine. All the medications had a similar safety profile.

The researchers did not find any head-to-head studies, so instead examined the results from 26 RCTs that enrolled more than 15,000 patients. Only trials with a treatment duration of at least 16 weeks were included, to ensure that patients had at least a month of a fixed dose.

Not surprisingly, the review found that, except for semaglutide, trials with “dual and triple agonists generally reported numerically greater mean weight losses than single GLP-1 agonists.”

They caution, however, against drawing conclusions about comparative efficacy, as the populations, control groups, and contexts of the various studies might not be directly comparable. All the trial enrollees also received lifestyle modification along with drug therapy or placebo, but the interventions and protocols varied across the studies.

The authors found that individuals on retatrutide (12-mg once-weekly injection) lost 22% of body weight from baseline after 48 weeks. Tirzepatide (15 mg once-weekly injection) recipients lost almost 18% of body weight after 72 weeks, while those on semaglutide (2.4-mg once-weekly injection) lost about 14% after 68 weeks. Both tirzepatide and semaglutide are commercially available.

Patients taking liraglutide (3-mg once-daily injection), also on the market, lost up to 6% of body weight after 26 weeks.

The authors also examined studies of investigational agents and reported that the greatest loss, aside from retatrutide, was with the dual glucagon/GLP-1 agonists survodutide (Boehringer Ingelheim; 6%-15%) and mazdutide (Innovent Biologics; 7%-11%).

Orforglipron (Eli Lilly), a once-daily pill, produced weight loss of 9%-15%, depending on the dose.

The study found that four investigational drugs did not produce as much weight loss: Beinaglutide (0.2-mg injection three times daily, 6%), efpeglenatide (4- to 8-mg injection once weekly, about 7%), exenatide (10-mcg injection twice daily, 5-kg change in weight), and noiiglutide (once-daily injection, 9%).

The most common adverse events for all GLP-1s were gastrointestinal (GI), such as nausea, diarrhea, constipation, and vomiting. Across all agents, 60%-80% of patients taking the medications experienced a GI adverse event, although most were transient, according to the authors. A total of 6%-26% of patients discontinued treatment as a result of a side effect.

The authors said that no serious GI disorders, such as bowel obstruction or gastroparesis, were reported in any of the 26 trials.

The review also shows that it is likely that GLP-1s would have to be used chronically to have the greatest effect, said the authors. They noted that they found that trials “with longer treatment durations demonstrate similar weight loss results to those with shorter follow-up, reinforcing the idea that continuous treatment may be required.”

One coauthor reported receiving payments or honoraria from Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, and Novo Nordisk. The study was carried out independently without any grant or other funding.

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

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Using AI to ID Osteoporosis: A Medico-Legal Minefield?

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Could an artificial intelligence (AI)–driven tool that mines medical records for suspected cases of osteoporosis be so successful that it becomes a potential liability? Yes, according to Christopher White, PhD, executive director of Maridulu Budyari Gumal, the Sydney Partnership for Health, Education, Research, and Enterprise, a research translation center in Liverpool, Australia.

In a thought-provoking presentation at the Endocrine Society’s AI in Healthcare Virtual Summit, White described the results after his fracture liaison team at Prince of Wales Hospital in Randwick, Australia, tried to plug the “osteoporosis treatment gap” by mining medical records to identify patients with the disorder.

 

‘Be Careful What You Wish For’

White and colleagues developed a robust standalone database over 20 years that informed fracture risk among patients with osteoporosis in Sydney. The database included all relevant clinical information, as well as bone density measurements, on about 30,000 patients and could be interrogated for randomized controlled trial recruitment.

However, a “crisis” occurred around 2011, when the team received a recruitment request for the first head-to-head comparison of alendronate with romosozumab. “We had numerous postmenopausal women in the age range with the required bone density, but we hadn’t captured the severity of their vertebral fracture or how many they actually had,” White told the this news organization. For recruitment into the study, participants must have had at least two moderate or severe vertebral fractures or a proximal vertebral fracture that was sustained between 3 and 24 months before recruitment.

White turned to his hospital’s mainframe, which had coding data and time intervals for patients who were admitted with vertebral or hip fractures. He calculated how many patients who met the study criteria had been discharged and how many of those he thought he’d be able to capture through the mainframe. He was confident he would have enough, but he was wrong. He underrecruited and could not participate in the trial.

Determined not to wind up in a similar situation in the future, he investigated and found that other centers were struggling with similar problems. This led to a collaboration with four investigators who were using AI and Advanced Encryption Standard (AES) coding to identify patients at risk for osteoporotic fractures. White, meanwhile, had developed a natural language processing tool called XRAIT that also identified patients at fracture risk. A study comparing the two electronic search programs, which screen medical records for fractures, found that both reliably identified patients who had had a fracture. White and his colleagues concluded that hybrid tools combining XRAIT and AES would likely improve the identification of patients with osteoporosis who would require follow-up or might participate in future trials.

Those patients were not being identified sooner for multiple reasons, White explained. Sometimes, the radiologist would report osteoporosis, but it wouldn’t get coded. Or, in the emergency department, a patient with a fracture would be treated and then sent home, and the possibility of osteoporosis wasn’t reported.

“As we went deeper and deeper with our tools into the medical record, we found more and more patients who hadn’t been coded or reported but who actually had osteoporosis,” White said. “It was incredibly prevalent.”

But the number of patients identified was more than the hospital could comfortably handle.

Ironically, he added, “To my relief and probably not to the benefit of the patients, there was a system upgrade of the radiology reporting system, which was incompatible with the natural language processing technology that I had installed. The AI was turned off at that point, but I had a look over the edge and into the mine pit.”

“The lesson learned,” White told this news organization, is “If you mine the medical record for unidentified patients before you know what to do with the output, you create a medico-legal minefield. You need to be careful what you wish for with technology, because it may actually come true.”

 

Grappling With the Treatment Gap

An (over)abundance of patients is likely contributing to the “osteoporosis treatment gap” that Australia’s fracture liaison services, which handle many of these patients, are grappling with. One recent meta-analysis showed that not all eligible patients are treated and that not all patients who are treated actually start treatment. Another study showed that only a minority of patients — anywhere between 20% and 40% — who start are still persisting at about 3 years, White said.

Various types of fracture liaison services exist, he noted. The model that has been shown to best promote adherence is the one requiring clinicians to “identify, educate [usually, the primary care physician], evaluate, start treatment, continue treatment, and follow-up at 12 months for to confirm that there is adherence.”

What’s happening now, he said, is that the technology is identifying a high number of vertebral crush fractures, and there’s no education or evaluation. “The radiologist just refers the patient to a primary care physician and hopes for the best. AI isn’t contributing to solving the treatment gap problem; it’s amplifying it. It’s ahead of the ability of organizations to accommodate the findings.”

Solutions, he said, would require support at the top of health systems and organizations, and funding to proceed; data surveys concentrating on vertical integration of the medical record to follow patients wherever they are — eg, hospital, primary care — in their health journeys; a workflow with synchronous diagnosis and treatment planning, delivery, monitoring, and payment; and clinical and community champions advocating and “leading the charge in health tech.”

Furthermore, he advised, organizations need to be “very, very careful with safety and security — that is, managing the digital risks.”

“Oscar Wilde said there are two tragedies in life: One is not getting what one wants, and the other is getting it,” White concluded. “In my career, we’ve moved on from not knowing how to treat osteoporosis to knowing how to treat it. And that is both an asset and a liability.”

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

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Could an artificial intelligence (AI)–driven tool that mines medical records for suspected cases of osteoporosis be so successful that it becomes a potential liability? Yes, according to Christopher White, PhD, executive director of Maridulu Budyari Gumal, the Sydney Partnership for Health, Education, Research, and Enterprise, a research translation center in Liverpool, Australia.

In a thought-provoking presentation at the Endocrine Society’s AI in Healthcare Virtual Summit, White described the results after his fracture liaison team at Prince of Wales Hospital in Randwick, Australia, tried to plug the “osteoporosis treatment gap” by mining medical records to identify patients with the disorder.

 

‘Be Careful What You Wish For’

White and colleagues developed a robust standalone database over 20 years that informed fracture risk among patients with osteoporosis in Sydney. The database included all relevant clinical information, as well as bone density measurements, on about 30,000 patients and could be interrogated for randomized controlled trial recruitment.

However, a “crisis” occurred around 2011, when the team received a recruitment request for the first head-to-head comparison of alendronate with romosozumab. “We had numerous postmenopausal women in the age range with the required bone density, but we hadn’t captured the severity of their vertebral fracture or how many they actually had,” White told the this news organization. For recruitment into the study, participants must have had at least two moderate or severe vertebral fractures or a proximal vertebral fracture that was sustained between 3 and 24 months before recruitment.

White turned to his hospital’s mainframe, which had coding data and time intervals for patients who were admitted with vertebral or hip fractures. He calculated how many patients who met the study criteria had been discharged and how many of those he thought he’d be able to capture through the mainframe. He was confident he would have enough, but he was wrong. He underrecruited and could not participate in the trial.

Determined not to wind up in a similar situation in the future, he investigated and found that other centers were struggling with similar problems. This led to a collaboration with four investigators who were using AI and Advanced Encryption Standard (AES) coding to identify patients at risk for osteoporotic fractures. White, meanwhile, had developed a natural language processing tool called XRAIT that also identified patients at fracture risk. A study comparing the two electronic search programs, which screen medical records for fractures, found that both reliably identified patients who had had a fracture. White and his colleagues concluded that hybrid tools combining XRAIT and AES would likely improve the identification of patients with osteoporosis who would require follow-up or might participate in future trials.

Those patients were not being identified sooner for multiple reasons, White explained. Sometimes, the radiologist would report osteoporosis, but it wouldn’t get coded. Or, in the emergency department, a patient with a fracture would be treated and then sent home, and the possibility of osteoporosis wasn’t reported.

“As we went deeper and deeper with our tools into the medical record, we found more and more patients who hadn’t been coded or reported but who actually had osteoporosis,” White said. “It was incredibly prevalent.”

But the number of patients identified was more than the hospital could comfortably handle.

Ironically, he added, “To my relief and probably not to the benefit of the patients, there was a system upgrade of the radiology reporting system, which was incompatible with the natural language processing technology that I had installed. The AI was turned off at that point, but I had a look over the edge and into the mine pit.”

“The lesson learned,” White told this news organization, is “If you mine the medical record for unidentified patients before you know what to do with the output, you create a medico-legal minefield. You need to be careful what you wish for with technology, because it may actually come true.”

 

Grappling With the Treatment Gap

An (over)abundance of patients is likely contributing to the “osteoporosis treatment gap” that Australia’s fracture liaison services, which handle many of these patients, are grappling with. One recent meta-analysis showed that not all eligible patients are treated and that not all patients who are treated actually start treatment. Another study showed that only a minority of patients — anywhere between 20% and 40% — who start are still persisting at about 3 years, White said.

Various types of fracture liaison services exist, he noted. The model that has been shown to best promote adherence is the one requiring clinicians to “identify, educate [usually, the primary care physician], evaluate, start treatment, continue treatment, and follow-up at 12 months for to confirm that there is adherence.”

What’s happening now, he said, is that the technology is identifying a high number of vertebral crush fractures, and there’s no education or evaluation. “The radiologist just refers the patient to a primary care physician and hopes for the best. AI isn’t contributing to solving the treatment gap problem; it’s amplifying it. It’s ahead of the ability of organizations to accommodate the findings.”

Solutions, he said, would require support at the top of health systems and organizations, and funding to proceed; data surveys concentrating on vertical integration of the medical record to follow patients wherever they are — eg, hospital, primary care — in their health journeys; a workflow with synchronous diagnosis and treatment planning, delivery, monitoring, and payment; and clinical and community champions advocating and “leading the charge in health tech.”

Furthermore, he advised, organizations need to be “very, very careful with safety and security — that is, managing the digital risks.”

“Oscar Wilde said there are two tragedies in life: One is not getting what one wants, and the other is getting it,” White concluded. “In my career, we’ve moved on from not knowing how to treat osteoporosis to knowing how to treat it. And that is both an asset and a liability.”

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

Could an artificial intelligence (AI)–driven tool that mines medical records for suspected cases of osteoporosis be so successful that it becomes a potential liability? Yes, according to Christopher White, PhD, executive director of Maridulu Budyari Gumal, the Sydney Partnership for Health, Education, Research, and Enterprise, a research translation center in Liverpool, Australia.

In a thought-provoking presentation at the Endocrine Society’s AI in Healthcare Virtual Summit, White described the results after his fracture liaison team at Prince of Wales Hospital in Randwick, Australia, tried to plug the “osteoporosis treatment gap” by mining medical records to identify patients with the disorder.

 

‘Be Careful What You Wish For’

White and colleagues developed a robust standalone database over 20 years that informed fracture risk among patients with osteoporosis in Sydney. The database included all relevant clinical information, as well as bone density measurements, on about 30,000 patients and could be interrogated for randomized controlled trial recruitment.

However, a “crisis” occurred around 2011, when the team received a recruitment request for the first head-to-head comparison of alendronate with romosozumab. “We had numerous postmenopausal women in the age range with the required bone density, but we hadn’t captured the severity of their vertebral fracture or how many they actually had,” White told the this news organization. For recruitment into the study, participants must have had at least two moderate or severe vertebral fractures or a proximal vertebral fracture that was sustained between 3 and 24 months before recruitment.

White turned to his hospital’s mainframe, which had coding data and time intervals for patients who were admitted with vertebral or hip fractures. He calculated how many patients who met the study criteria had been discharged and how many of those he thought he’d be able to capture through the mainframe. He was confident he would have enough, but he was wrong. He underrecruited and could not participate in the trial.

Determined not to wind up in a similar situation in the future, he investigated and found that other centers were struggling with similar problems. This led to a collaboration with four investigators who were using AI and Advanced Encryption Standard (AES) coding to identify patients at risk for osteoporotic fractures. White, meanwhile, had developed a natural language processing tool called XRAIT that also identified patients at fracture risk. A study comparing the two electronic search programs, which screen medical records for fractures, found that both reliably identified patients who had had a fracture. White and his colleagues concluded that hybrid tools combining XRAIT and AES would likely improve the identification of patients with osteoporosis who would require follow-up or might participate in future trials.

Those patients were not being identified sooner for multiple reasons, White explained. Sometimes, the radiologist would report osteoporosis, but it wouldn’t get coded. Or, in the emergency department, a patient with a fracture would be treated and then sent home, and the possibility of osteoporosis wasn’t reported.

“As we went deeper and deeper with our tools into the medical record, we found more and more patients who hadn’t been coded or reported but who actually had osteoporosis,” White said. “It was incredibly prevalent.”

But the number of patients identified was more than the hospital could comfortably handle.

Ironically, he added, “To my relief and probably not to the benefit of the patients, there was a system upgrade of the radiology reporting system, which was incompatible with the natural language processing technology that I had installed. The AI was turned off at that point, but I had a look over the edge and into the mine pit.”

“The lesson learned,” White told this news organization, is “If you mine the medical record for unidentified patients before you know what to do with the output, you create a medico-legal minefield. You need to be careful what you wish for with technology, because it may actually come true.”

 

Grappling With the Treatment Gap

An (over)abundance of patients is likely contributing to the “osteoporosis treatment gap” that Australia’s fracture liaison services, which handle many of these patients, are grappling with. One recent meta-analysis showed that not all eligible patients are treated and that not all patients who are treated actually start treatment. Another study showed that only a minority of patients — anywhere between 20% and 40% — who start are still persisting at about 3 years, White said.

Various types of fracture liaison services exist, he noted. The model that has been shown to best promote adherence is the one requiring clinicians to “identify, educate [usually, the primary care physician], evaluate, start treatment, continue treatment, and follow-up at 12 months for to confirm that there is adherence.”

What’s happening now, he said, is that the technology is identifying a high number of vertebral crush fractures, and there’s no education or evaluation. “The radiologist just refers the patient to a primary care physician and hopes for the best. AI isn’t contributing to solving the treatment gap problem; it’s amplifying it. It’s ahead of the ability of organizations to accommodate the findings.”

Solutions, he said, would require support at the top of health systems and organizations, and funding to proceed; data surveys concentrating on vertical integration of the medical record to follow patients wherever they are — eg, hospital, primary care — in their health journeys; a workflow with synchronous diagnosis and treatment planning, delivery, monitoring, and payment; and clinical and community champions advocating and “leading the charge in health tech.”

Furthermore, he advised, organizations need to be “very, very careful with safety and security — that is, managing the digital risks.”

“Oscar Wilde said there are two tragedies in life: One is not getting what one wants, and the other is getting it,” White concluded. “In my career, we’ve moved on from not knowing how to treat osteoporosis to knowing how to treat it. And that is both an asset and a liability.”

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

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Using GLP-1s to Meet BMI Goal for Orthopedic Surgery

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The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

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The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

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RSV Vaccines and Treatments Face Global Access Hurdles

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Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.

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Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.

Almost 70 years after the discovery of the respiratory syncytial virus (RSV), vaccines and preventive treatments are giving babies a chance to beat the potentially deadly childhood infection.

As doctors turn to monoclonal antibody therapies and governments plan vaccination programs, clinical researchers are asking whether these measures will reduce the spread of the virus. Will fewer babies die from RSV, and fewer children develop permanent wheezing?

Recent studies offer clues.

Fabio Midulla, an associate professor of pediatrics at Sapienza University of Rome in Rome, Italy, said that the pharmaceutical industry is poised to push governments to use vaccines and monoclonal antibodies for even more children. “Such a push might work,” he said at the European Respiratory Society (ERS) 2024 Congress, “given that several studies have already demonstrated that their use can improve outcomes for children who do become infected and reduce societal costs by reducing hospitalizations.”

But Mariëlle WH Pijnenburg, a pulmonary specialist at Erasmus University Rotterdam in the Netherlands, said at the Congress that greater rollout would require governments to force industry to lower prices. If treatments remain beyond the reach of lower-income countries — where the burden of RSV is the greatest — the death toll from this common childhood infection will remain stubbornly high, and the prospect of global elimination will remain forever out of reach, she said.

New Tools in the Fight Against RSV

Nirsevimab, a long-acting monoclonal antibody given to newborns to prevent severe infection, was approved by the European Medicines Agency (EMA) in October 2022 and the US Food and Drug Administration (FDA) in July 2023. And Abrysvo, a vaccine given to older adults and pregnant women to stop them from passing the virus to babies from birth through 6 months of age, was approved by the FDA and the EMA in 2023.

RSV is responsible for over 33 million lung infections in children younger than 5 years annually, with more than 4 million hospitalizations and nearly 200,000 deaths. According to the Centers for Disease Control and Prevention, every year, 2.1 million children younger than 5 years old visit a healthcare provider because of an RSV infection and between 58,000 and 80,000 children younger than 5 years old are hospitalized in the United States. The burden of severe RSV disease is also high among adults, with an estimated 123,000-193,000 hospitalizations, 24,400-34,900 ICU admissions, and 4680-8620 in-hospital deaths occurring annually among US adults.

While the virus affects all age groups, it is particularly severe in infants, swelling their airways and causing them to struggle for breath. Infection in infancy can lead to later complications, such as the development of wheezing, a condition that causes breathlessness and a feeling of tightening in the chest, and possibly also asthma.

Studies have shown that children and preterm infants infected with RSV who were given monoclonal antibodies experienced less post-infection wheezing, suggesting that RSV prophylaxis could prevent the development of wheezing bronchitis.

study conducted in Galicia, Spain, showed that only 0.3% of infants who received prophylaxis with Nirsevimab were hospitalized for RSV-related lower respiratory tract infections. “This is very promising,” Yvonne Maldonado, MD, professor of pediatrics and epidemiology and population health at Stanford University in Stanford, California, told Medscape Medical News. “But this virus is ubiquitous. It’s found everywhere. It comes around every winter season. And immunity is not long-lasting.”

Older children who are not receiving monoclonal antibodies still experience RSV-related hospitalizations, suggesting the virus continues to circulate at high enough levels in the community. “The vaccine and monoclonal antibodies can reduce the risk of hospitalization and more severe disease in young kids, but they won’t eliminate the virus,” Maldonado said. “Right now, the goal is to prevent serious infection, not to prevent the spread of the virus completely.”

Expanding Access to RSV Prevention in Low-Income Countries

Currently, the RSV vaccine and monoclonal antibodies are only given in the United States, Europe, United Kingdom, and Canada to newborns, children at risk for severe disease, and pregnant women. However, Midulla said that pharmaceutical companies are pushing to broaden the rollout to a broader population within these countries. Yet, he said, over 99% of RSV infection–related deaths occur in the Global South.

No pharmaceutical company has sought approval in low-income countries such as those in Africa. “Unless they see there being a market in a country, they’re not going to go through the onerous process of getting [a vaccine] licensed,” Shabir Madhi, dean of the faculty of health sciences and a professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, told Medscape Medical News.

He highlighted that almost 50% of RSV-related deaths occur in African children younger than 5 years, despite these children comprising just one fifth of the global under-5 population. The high burden of RSV mortality in the Global South is mainly due to poor access to healthcare and supportive treatments, such as supplemental oxygen, which can help children recover from severe RSV infection.

Companies are unlikely to pursue regulatory approval and licensing in low- and middle-income countries until GAVI, the global vaccine alliance, commits to procuring and funding the vaccines for these regions. GAVI’s decision would provide the necessary market incentive for manufacturers to seek approval.

Madhi suggested that GAVI’s decision on RSV vaccine procurement is imminent, likely early next year, following the World Health Organization’s Strategic Advisory Group of Experts on Immunization recommendation to vaccinate all pregnant women with the RSV vaccine, regardless of whether they are in high-income or low-income countries.

Nevertheless, even if vaccines become available, many African countries may still struggle to afford them. Madhi said that these countries would likely depend on GAVI and organizations like UNICEF to procure the vaccines at affordable prices. “The unfortunate reality is that many countries — especially in Africa — still wouldn’t be able to afford it, even if the vaccine cost as little as $5,” said Madhi. “But that’s where they would have the greatest impact.”

Midulla, Pijnenburg reported no relevant financial relationships. Madhi’s research unit, the Vaccines and Infectious Disease Analytics Unit, was involved in the clinical trials for the Pfizer RSV vaccine, the GSK RSV vaccine (which was terminated), as well as the MEDLEY trial of palivizumab. All funding for these studies went to his institution, the University of the Witwatersrand. Maldonado was Stanford principal investigator for the Pfizer RSV vaccine.
 

A version of this article appeared on Medscape.com.

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Hypermucoviscous K pneumoniae Shows Reduced Drug Resistance

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TOPLINE:

Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.

METHODOLOGY:

  • Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
  • They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
  • These studies spanned across four continents: Asia, Africa, Europe, and North America.
  • The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.

TAKEAWAY:

  • The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
  • Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).

IN PRACTICE:

“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.

SOURCE:

The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.

LIMITATIONS:

Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.

DISCLOSURES:

No funding sources were mentioned, and no conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.

METHODOLOGY:

  • Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
  • They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
  • These studies spanned across four continents: Asia, Africa, Europe, and North America.
  • The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.

TAKEAWAY:

  • The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
  • Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).

IN PRACTICE:

“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.

SOURCE:

The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.

LIMITATIONS:

Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.

DISCLOSURES:

No funding sources were mentioned, and no conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Hypermucoviscous Klebsiella pneumoniae (hmKp) strains demonstrate a significantly lower prevalence of extended-spectrum beta-lactamase (ESBL) production and slightly lower carbapenem resistance than non-hmKp strains, according to a recent meta-analysis of 2049 clinical isolates.

METHODOLOGY:

  • Researchers conducted a meta-analysis to assess the prevalence of ESBL-producing strains and carbapenem-resistant strains among the hmKp and non-hmKp clinical isolates.
  • They included 15 studies published between 2014 and 2023, with 2049 clinical isolates of K pneumoniae identified using a string test to distinguish hypermucoviscous from non-hypermucoviscous strains.
  • These studies spanned across four continents: Asia, Africa, Europe, and North America.
  • The primary outcome was the prevalence of ESBL-producing and carbapenem-resistant strains, determined through antimicrobial susceptibility testing.

TAKEAWAY:

  • The hmKp strains were associated with a significantly lower prevalence of ESBL-producing strains than non-hmKp strains (pooled odds ratio [OR], 0.26; P = .003).
  • Similarly, hmKp strains were associated with a slightly lower prevalence of carbapenem-resistant strains than non-hmKp strains (pooled OR, 0.63; P = .038).

IN PRACTICE:

“Therapeutic options for CRKP [carbapenem-resistant K pneumoniae] infections are extremely limited due to the scarcity of effective antibacterial drugs. Therefore, it is crucial to consider the risks posed by CRKP strains when administering treatment to patients with hmKp infections and a history of the aforementioned risk factors,” the authors wrote.

SOURCE:

The study was led by Hiroki Namikawa, Department of Medical Education and General Practice, Graduate School of Medicine, Osaka Metropolitan University, Japan. It was published online on December 16, 2024, in Emerging Microbes & Infections.

LIMITATIONS:

Only three databases (PubMed, Scopus, and Cochrane Library) were searched for identifying studies, potentially missing relevant studies from other sources. Furthermore, only articles published in English were included, which may have restricted the scope of analysis. Additionally, geographical distribution was predominantly limited to Asia, limiting the global applicability of the results.

DISCLOSURES:

No funding sources were mentioned, and no conflicts of interest were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Lupus Ups Atherosclerosis Risk, But Disease Remission Helps

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Changed

TOPLINE:

Patients with systemic lupus erythematosus (SLE) face more than double the risk for atherosclerotic plaque progression than healthy control individuals without the condition, but management of traditional cardiovascular risk factors and prolonged clinical remission can successfully mitigate it.

METHODOLOGY:

  • Researchers performed a prospective study to assess the progression of subclinical atherosclerosis plaques and the development of cardiovascular events in patients with SLE over a 10-year follow-up period.
  • They included 111 patients with SLE (mean age, 43 years; 91% women) and 94 matched healthy control individuals without prior atherosclerotic cardiovascular disease (CVD), active malignancy, pregnancy, or diabetes mellitus who underwent carotid ultrasound measurements.
  • A total of 738 carotid measurements were analyzed from baseline to 3-, 7-, and 10-year follow-up periods for assessing new carotid plaque development; incident CVD events were also analyzed during follow-up.
  • Disease remission was evaluated based on the Definition of Remission in SLE criteria.
  • Target for management of cardiovascular risk factors was based on standard recommendations.
  •  

TAKEAWAY:

  • During the 10-year follow-up, patients with SLE showed a 2.3-fold higher risk for plaque progression than healthy control participants (adjusted incidence rate ratio [aIRR], 2.26; P = .002).
  • Achieving risk reduction target for each standard cardiovascular risk factor (blood pressure, lipids, smoking, body weight, and physical activity) was associated with a 32% reduction in the risk for plaque progression (aIRR, 0.68; P = .004).
  • Staying in remission for ≥ 75% of the follow-up period was significantly associated with a 43% reduction in the risk for plaque progression (aIRR, 0.57; P = .033).
  • Patients with SLE also had a higher incidence of CVD events than healthy control participants (permutation-based log-rank P = .036).
  •  

IN PRACTICE:

“These findings support the importance of prioritizing sustained remission rather than a low disease activity state for the prevention of atherosclerosis development and progression in SLE,” the authors wrote.

SOURCE:

The study was led by Nikolaos Papazoglou, MD, First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens in Greece. It was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study had limited statistical power to perform a multivariate analysis of incident CVD events due to low event rates. The cohort consisted solely of White Europeans, possibly limiting the generalizability of the findings to more ethnically diverse populations. Because antiphospholipid antibodies are known to be associated with CVD events in the general population, the lack of testing for antiphospholipid antibody positivity in healthy control participants could be another limitation.

DISCLOSURES:

The study did not receive any funding from public, commercial, or not-for-profit sectors. The authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Patients with systemic lupus erythematosus (SLE) face more than double the risk for atherosclerotic plaque progression than healthy control individuals without the condition, but management of traditional cardiovascular risk factors and prolonged clinical remission can successfully mitigate it.

METHODOLOGY:

  • Researchers performed a prospective study to assess the progression of subclinical atherosclerosis plaques and the development of cardiovascular events in patients with SLE over a 10-year follow-up period.
  • They included 111 patients with SLE (mean age, 43 years; 91% women) and 94 matched healthy control individuals without prior atherosclerotic cardiovascular disease (CVD), active malignancy, pregnancy, or diabetes mellitus who underwent carotid ultrasound measurements.
  • A total of 738 carotid measurements were analyzed from baseline to 3-, 7-, and 10-year follow-up periods for assessing new carotid plaque development; incident CVD events were also analyzed during follow-up.
  • Disease remission was evaluated based on the Definition of Remission in SLE criteria.
  • Target for management of cardiovascular risk factors was based on standard recommendations.
  •  

TAKEAWAY:

  • During the 10-year follow-up, patients with SLE showed a 2.3-fold higher risk for plaque progression than healthy control participants (adjusted incidence rate ratio [aIRR], 2.26; P = .002).
  • Achieving risk reduction target for each standard cardiovascular risk factor (blood pressure, lipids, smoking, body weight, and physical activity) was associated with a 32% reduction in the risk for plaque progression (aIRR, 0.68; P = .004).
  • Staying in remission for ≥ 75% of the follow-up period was significantly associated with a 43% reduction in the risk for plaque progression (aIRR, 0.57; P = .033).
  • Patients with SLE also had a higher incidence of CVD events than healthy control participants (permutation-based log-rank P = .036).
  •  

IN PRACTICE:

“These findings support the importance of prioritizing sustained remission rather than a low disease activity state for the prevention of atherosclerosis development and progression in SLE,” the authors wrote.

SOURCE:

The study was led by Nikolaos Papazoglou, MD, First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens in Greece. It was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study had limited statistical power to perform a multivariate analysis of incident CVD events due to low event rates. The cohort consisted solely of White Europeans, possibly limiting the generalizability of the findings to more ethnically diverse populations. Because antiphospholipid antibodies are known to be associated with CVD events in the general population, the lack of testing for antiphospholipid antibody positivity in healthy control participants could be another limitation.

DISCLOSURES:

The study did not receive any funding from public, commercial, or not-for-profit sectors. The authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Patients with systemic lupus erythematosus (SLE) face more than double the risk for atherosclerotic plaque progression than healthy control individuals without the condition, but management of traditional cardiovascular risk factors and prolonged clinical remission can successfully mitigate it.

METHODOLOGY:

  • Researchers performed a prospective study to assess the progression of subclinical atherosclerosis plaques and the development of cardiovascular events in patients with SLE over a 10-year follow-up period.
  • They included 111 patients with SLE (mean age, 43 years; 91% women) and 94 matched healthy control individuals without prior atherosclerotic cardiovascular disease (CVD), active malignancy, pregnancy, or diabetes mellitus who underwent carotid ultrasound measurements.
  • A total of 738 carotid measurements were analyzed from baseline to 3-, 7-, and 10-year follow-up periods for assessing new carotid plaque development; incident CVD events were also analyzed during follow-up.
  • Disease remission was evaluated based on the Definition of Remission in SLE criteria.
  • Target for management of cardiovascular risk factors was based on standard recommendations.
  •  

TAKEAWAY:

  • During the 10-year follow-up, patients with SLE showed a 2.3-fold higher risk for plaque progression than healthy control participants (adjusted incidence rate ratio [aIRR], 2.26; P = .002).
  • Achieving risk reduction target for each standard cardiovascular risk factor (blood pressure, lipids, smoking, body weight, and physical activity) was associated with a 32% reduction in the risk for plaque progression (aIRR, 0.68; P = .004).
  • Staying in remission for ≥ 75% of the follow-up period was significantly associated with a 43% reduction in the risk for plaque progression (aIRR, 0.57; P = .033).
  • Patients with SLE also had a higher incidence of CVD events than healthy control participants (permutation-based log-rank P = .036).
  •  

IN PRACTICE:

“These findings support the importance of prioritizing sustained remission rather than a low disease activity state for the prevention of atherosclerosis development and progression in SLE,” the authors wrote.

SOURCE:

The study was led by Nikolaos Papazoglou, MD, First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens in Greece. It was published online on December 25, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

The study had limited statistical power to perform a multivariate analysis of incident CVD events due to low event rates. The cohort consisted solely of White Europeans, possibly limiting the generalizability of the findings to more ethnically diverse populations. Because antiphospholipid antibodies are known to be associated with CVD events in the general population, the lack of testing for antiphospholipid antibody positivity in healthy control participants could be another limitation.

DISCLOSURES:

The study did not receive any funding from public, commercial, or not-for-profit sectors. The authors reported no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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