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More evidence shows COVID-19’s link to risk for autoimmune disease

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Changed
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TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

  • In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
  • Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
  • Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

  • Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
  • Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
  •  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

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TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

  • In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
  • Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
  • Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

  • Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
  • Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
  •  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

 

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

  • In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
  • Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
  • Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

  • Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
  • Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
  •  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

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Choosing which biologic to prescribe for psoriasis

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With 11 different biologics approved for the treatment of plaque psoriasis on the market, settling on which one to prescribe can be tricky.

“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.

Dr. Armstrong
Dr. April W. Armstrong

One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.

In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).

In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).

In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”

Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.



Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.

The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.

She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”

She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”

If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”

Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.

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With 11 different biologics approved for the treatment of plaque psoriasis on the market, settling on which one to prescribe can be tricky.

“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.

Dr. Armstrong
Dr. April W. Armstrong

One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.

In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).

In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).

In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”

Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.



Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.

The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.

She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”

She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”

If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”

Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.

With 11 different biologics approved for the treatment of plaque psoriasis on the market, settling on which one to prescribe can be tricky.

“When you look at the list of options it can be confusing to many clinicians in deciding which one to choose,” April W. Armstrong, MD, MPH, professor and chief of dermatology at the University of California, Los Angeles, said at the annual symposium of the California Society of Dermatology & Dermatologic Surgery.

Dr. Armstrong
Dr. April W. Armstrong

One approach is to consider how the biologics compare in short- and long-term efficacy. “Several different meta-analyses of biologics have been conducted,” which include some head-to head studies, Dr. Armstrong said. “In terms of efficacy, [biologics] are similar at the population level,” she said.

In a meta-analysis of 71 randomized, controlled trials through July 2020, Dr. Armstrong and colleagues found that in the short-term, Psoriasis Area and Severity Index (PASI) 90 response rates at 10-16 weeks from baseline were highest for ixekizumab (72.9%), risankizumab (72.5%), and brodalumab (72%). These PASI 90 responses were significantly higher than among patients on guselkumab (65%), secukinumab (65%), infliximab (56.8%), certolizumab (400 mg: 49.6%; 200 mg: 42.2%), ustekinumab (90 mg: 47.9%; weight-based: 45.7%; 45 mg: 44.6%), adalimumab (43%), tildrakizumab (200 mg: 39.7%; 100 mg: 37.2%), etanercept (18.0%), apremilast (12.4%), and dimethyl fumarate (12.2%).

In a more recent meta-analysis, Dr. Armstrong and coauthors used area under the curve (AUC) analyses to compare the cumulative clinical benefits of biologics over 1 year. They found that the placebo-adjusted normalized maximum AUC for a PASI 100 response was greatest for ixekizumab (0.436), risankizumab (0.423), and brodalumab (0.378), followed by guselkumab (0.358), secukinumab (0.324), ustekinumab (0.201), adalimumab (0.183), and etanercept (0.087).

In Dr. Armstrong’s opinion, the tumor necrosis factor (TNF) inhibitors etanercept, infliximab, adalimumab, and certolizumab “have served their purpose for plaque psoriasis over time, but these days I would probably choose either an IL [interleukin]-17 inhibitor or an IL-23 inhibitor first,” she said. Still, TNF inhibitors “are certainly good for psoriatic arthritis, and certolizumab is appropriate for patients who are pregnant or breastfeeding,” she said. “Avoid them in patients with demyelinating disease and in those with hepatitis B. They are not preferred in patients with latent TB or advanced CHF.”

Dr. Armstrong said that there are robust efficacy data for the IL-17 inhibitors ixekizumab, secukinumab, and brodalumab in psoriasis and in the peripheral and axial forms of psoriatic arthritis (PsA). “Avoid using them in patients with a personal history of inflammatory bowel disease,” she advised.



Low rates of oral candidiasis have been reported in the literature, “but this has not been issue with our approved IL-17 inhibitors so far,” she said.

The IL-23 inhibitors guselkumab, risankizumab, tildrakizumab, and ustekinumab have robust data for psoriasis efficacy, she said, and three – guselkumab, risankizumab, and ustekinumab – are also approved for PsA. “These agents have the advantage of fewer injections, and the evidence [of efficacy] for IL-23 inhibitors continues to evolve, such as in patients with psoriatic arthritis involving the spine,” Dr. Armstrong said.

She also shared how she deals with patients who fail to respond to biologics. “Do you switch drugs, or do you dose escalate?” she asked. “In most cases, the strategy for dose escalation is to shorten the interval between the injections so the dosing is delivered more frequently.” In a case of primary failure, which Dr. Armstrong defined as a patient who has never responded optimally to a biologic, consider revisiting the diagnosis. “Maybe it’s cutaneous T-cell lymphoma or some other condition, because our current IL-17 and IL-23 medications work extremely well,” she said. “So, if you have a patient who is not responding at all, I would question the diagnosis and consider a biopsy.”

She generally waits about 6 months before switching a patient to another biologic, “to see if they’re one of the late bloomers who may catch up in efficacy,” she explained. “Switching the class of biologic is another consideration.”

If a patient had responded to the biologic for a long time and then lost response – known as secondary failure – Dr. Armstrong considers dose escalation or a switch to another agent within the same class “if it helps to address comorbidities such as PsA,” she said. “You can also try across-class switching.”

Dr. Armstrong disclosed ties with AbbVie, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermira, Dermavant, EPI, Galderma, InCyte, Janssen, Leo, Lilly, Meiji, Modmed, Nimbus, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi, Suna, UCB, and Ventyx.

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Pelvic yoga, physical conditioning both improve urinary incontinence

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Fri, 10/06/2023 - 13:21

– Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.

“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”

The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.

Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.

The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.

The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.

Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.

Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.

About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.

“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).

The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.

“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.

“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.

“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”

The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.

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– Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.

“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”

The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.

Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.

The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.

The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.

Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.

Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.

About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.

“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).

The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.

“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.

“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.

“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”

The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.

– Both a pelvic yoga program and a general physical conditioning program for incontinence led to improvements in women’s incontinence, according to a study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“As clinicians, we’re usually focused on treatments that we ourselves can prescribe, perform, or administer. We’re not as good as recommending or supporting treatment or management strategies that don’t rely on costly or intensive visits with clinical specialists,” lead author Alison Huang, MD, MAS, a professor of medicine at the University of California, San Francisco, said in an interview.

“But our findings suggest that women who try pelvic yoga as a complementary management strategy for genitourinary conditions like urinary incontinence that often emerge in midlife are likely to experience substantial improvement in their genitourinary symptoms and function,” Dr. Huang said. “Some of these improvements may be shared with other forms of low-impact physical movement or exercise.”

The 240 participants from communities around three Northern California sites ranged in age from 45 to 90 years old, with an average age of 62, and all had at least daily urgency, stress, or mixed-type urinary incontinence. While most were White women, 40% identified as racial/ethnic minorities, including 14% Hispanic, 6% Black, 16% Asian American, and 4% multiracial.

Participants needed to be able to walk two blocks on level ground and get from a supine to a standing position on their own, but they should not have recently participated in any organized yoga or physical conditioning exercise classes. They also needed to forgo behavioral, invasive, or pharmacologic treatments for urinary incontinence for at least 3 months. The trial ran from 2019 to 2022, with most women completing the 3-month program virtually once the pandemic began.

The 121 women randomly assigned to the pelvic yoga program had twice-weekly group instruction by trained yoga instructors and once-weekly individual practice. The practice focused on 16 standard Hatha yoga poses in standing, seated, supine, and prone positions with an emphasis on precise alignment of their postures during each pose. Yoga props, such as blocks, straps, or bolsters, were available to minimize risk of injury and to accommodate women with less flexibility.

The 119 women randomly assigned to the physical conditioning group spent the same amount of group and individual class time on skeletal muscle stretching and strengthening exercises. These exercises focused on strengthening and stretching exercises for the upper and lower extremities in standing, sitting, or supine positions. The only props needed were exercise straps and handles and an exercise mat, and the program was designed to be safe and feasible for women across all ages.

Both groups received standard self-management pamphlets describing pelvic floor muscle exercises and recommendations on timed urination and urging suppression. After early dropouts from both arms, 107 women remained for analysis in the pelvic yoga group, and 113 women remained for analysis in the physical conditioning group.

Researchers assessed participants’ genitourinary quality of life at baseline and after 3 months using the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), and Patient Perception of Bladder Condition (PPBC). At baseline, the women’s average scores were 38.8 on the UDI-6, 101 on the IIQ, and 3.4 on the PPBC.

About one-third of the women in both groups attended all 24 group classes, and 57% of women in both groups attended 20-23 classes. In addition, 65% of the women in the pelvic yoga group and 73% of the women in the physical conditioning group completed all of the recommended additional hours of individual practice. Only 15% of pelvic yoga participants and 9% of physical conditioning participants completed less than 80% of the recommended individual practice hours. No differences in participation between the groups were statistically significant.

“Over 3 months, scores on all genitourinary quality of life measures improved by more than the minimum important difference thresholds in the pelvic yoga group,” the researchers reported, but only the UDI-6 score improved significantly – albeit still modestly – in the pelvic yoga group, compared with the physical conditioning group. Average scores improved 18.9 points in the pelvic yoga group and 13.1 points in the physical conditioning group (5.8-point difference; P = .02).

The scores on the IIQ improved an average 38.5 points in the pelvic yoga group and 31.4 points in the physical conditioning group (P = .48). PPBC scores improved 0.7 points in both groups.

“While yoga may offer benefits for genitourinary quality of life, it may not offer superior benefits compared to equivalent-time practice of other activities that improve general physical function,” Dr. Huang told attendees.

“The bottom line is that physical activity toward incontinence is a helpful technique,” Stephanie Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health and medical director for the Menopause Society, said in an interview regarding the findings. Urinary incontinence is under-recognized, Dr. Faubion said, “because women are embarrassed, so they don’t bring it up, so it doesn’t get managed.” But it’s a common problem, so clinicians need to ask patients about it, she said.

“We should realize that, in midlife and older age, genitourinary health is often connected to overall health,” Dr. Huang said in an interview. “We shouldn’t focus exclusively on treatments that are directed solely at the genital or lower urinary tract organs or tissues. We should consider the ways in which women’s urinary and sexual function are influenced by other aspects of their physical and cognitive health.”

The research was funded by the National Institutes of Health. Dr. Huang and Dr. Faubion had no disclosures.

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Respiratory infections, asthma rise before type 2 diabetes

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Respiratory tract infections and asthma are 10 times more prevalent at type 2 diabetes diagnosis, compared with matched controls without a diagnosis, shows a longitudinal study looking at comorbidities both 25 years before and 25 years after a type 2 diabetes diagnosis.

About 40% of people had respiratory tract infections at the time of diagnosis with type 2 diabetes, compared with 4% who were not diagnosed. Likewise, ear, nose, and throat infections were present in 20% of people at type 2 diabetes diagnosis, compared with around 2% who were not diagnosed. A similar pattern was seen with asthma.

Taken together, the data suggest that subacute inflammation manifesting in asthma as well as the onset of asthma or an acute infection may be a precursor to a type 2 diabetes diagnosis.

“We have also found that in the years prior to diagnosis, there are associations with infections and inflammatory disorders to a much greater degree than in those people who do not get a diabetes diagnosis but who have very similar demographics,” Adrian Heald, MD, study lead and diabetes consultant from Salford (England) Royal Hospital, said in an interview.

Five years prior to diagnosis, respiratory tract infections were documented in around 23% of patients who were later diagnosed with type 2 diabetes versus 2.5% in those not diagnosed, and a similar pattern was seen for ear, nose, and throat infections and asthma. The findings suggest that patients reporting infections, in addition to other known risk factors for type 2 diabetes, might benefit from diabetes tests and early interventions, if needed.

“These novel insights offer a fascinating and fresh perspective on the onset and natural progression to type 2 diabetes and beyond, suggesting an early phase of inflammation-related disease activity long before any clinical diagnosis of type 2 diabetes is made.”

Dr. Heald points out that clinicians may intervene to stave off progression to a type 2 diabetes diagnosis in at risk patients. “At this point, an intervention could relate to lifestyle changes and involve highlighting to the patient that the morbidity they have already accumulated is suggestive of diabetes risk,” he said, adding that, “they may have dyslipidemia, hypertension, and most often excess weight so annual checks of their HbA1c, weight management, and blood pressure would need checking,” he explained.

Moderator Coen Stehouwer, MD, professor of internal medicine at Maastricht University, the Netherlands, commented, “Before clinical diagnosis of type 2 diabetes there is often a lengthy period of undiagnosed disease and before that, prediabetes, because glucose can be abnormal up to 10 years prior to clinical diagnosis.”

But he added that, “It’s not entirely clear whether the rise seen before clinical diagnosis in this study correlates with undiagnosed diabetes or prediabetes or even if it precedes type 2 diabetes – it might be because inflammation is a common origin for type 2 diabetes and various comorbidities. This might explain how they go together.”
 

Longitudinal study 25 years before and 25 years after type 2 diagnosis

Dr. Heald presented the findings at a session on inflammation in diabetes at the annual meeting of the European Association for the Study of Diabetes. The work was also published in Diabetes Therapy.

The researchers wanted to investigate the pattern of comorbidities in the years and decades prior to a diagnosis of type 2 diabetes as well as after: “With the database we used, called DARE [Diabetes Alliance for Research in England], we are able to explore phenomena longitudinally going right back to the beginning of their digital health records, looking at phenotypes over time.”

By mapping significant health issues in people who went on to develop type 2 diabetes alongside those that did not, Dr. Heald managed to develop a continuum spanning 25 years prior and 25 years after diagnosis of type 2 diabetes. The researchers also examined relationships between sociodemographic factors and longitudinal health outcomes of relevance to cardiac conditions and lower respiratory tract infections. His talk in Hamburg primarily addressed clinical phenotypes before the point of diagnosis.

Data were drawn from 1,932 people with (1,196) and without (736) type 2 diabetes. Participants in both groups were aged 66-67 years, 43%-46% were women, age at diagnosis was 50-52 years, and participants lived in Greater Manchester, United Kingdom.

In the years leading up to type 2 diagnosis, individuals consistently exhibited a considerable increase in several clinical phenotypes, reported Dr. Heald. Of note, he added, “immediately prior to type 2 diagnosis, there was a significantly greater proportion of hypertension at 35%, respiratory tract infection at 34%, heart disease at 17%, ear, nose, and throat infection at 19%, and asthma at 12%. And by comparison, the corresponding disease trajectory in matched controls was much less dramatic.”

“There is a huge difference in people who went on to receive a diagnosis of type 2 diabetes and those who did not, and not just what we’d expect – so hypertension for example or manifestations of renal disease, but importantly inflammatory disorders are more common,” he emphasized.

In addition, a larger signal for ischemic heart disease was seen just before type 2 diabetes diagnosis.

These data suggest that longitudinal clinical histories prior to a diagnosis of type 2 diabetes might offer new information, both genetic and nongenetic, about development of type 2 diabetes in relation to comorbidities.

After type 2 diabetes diagnosis, the proportion of people exhibiting coronary artery disease, hypertension, chronic kidney disease, retinopathy, and infections climbed rapidly before plateauing, reported Dr. Heald. “We also know that individuals with coronary artery disease are more highly represented in socially disadvantaged groups, and this is borne out in the data at 25 years prior and after type 2 diagnosis.”

Dr. Heald has received speaker fees or contributed to advisory boards from Lilly, AstraZeneca, Janssen, Bristol-Myers Squibb, Besins, Bayer, Sanofi, and Recordati. Research grants from Novo Nordisk, Pfizer, and Besins. Professor Stehouwer has declared no relevant conflicts.

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

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Respiratory tract infections and asthma are 10 times more prevalent at type 2 diabetes diagnosis, compared with matched controls without a diagnosis, shows a longitudinal study looking at comorbidities both 25 years before and 25 years after a type 2 diabetes diagnosis.

About 40% of people had respiratory tract infections at the time of diagnosis with type 2 diabetes, compared with 4% who were not diagnosed. Likewise, ear, nose, and throat infections were present in 20% of people at type 2 diabetes diagnosis, compared with around 2% who were not diagnosed. A similar pattern was seen with asthma.

Taken together, the data suggest that subacute inflammation manifesting in asthma as well as the onset of asthma or an acute infection may be a precursor to a type 2 diabetes diagnosis.

“We have also found that in the years prior to diagnosis, there are associations with infections and inflammatory disorders to a much greater degree than in those people who do not get a diabetes diagnosis but who have very similar demographics,” Adrian Heald, MD, study lead and diabetes consultant from Salford (England) Royal Hospital, said in an interview.

Five years prior to diagnosis, respiratory tract infections were documented in around 23% of patients who were later diagnosed with type 2 diabetes versus 2.5% in those not diagnosed, and a similar pattern was seen for ear, nose, and throat infections and asthma. The findings suggest that patients reporting infections, in addition to other known risk factors for type 2 diabetes, might benefit from diabetes tests and early interventions, if needed.

“These novel insights offer a fascinating and fresh perspective on the onset and natural progression to type 2 diabetes and beyond, suggesting an early phase of inflammation-related disease activity long before any clinical diagnosis of type 2 diabetes is made.”

Dr. Heald points out that clinicians may intervene to stave off progression to a type 2 diabetes diagnosis in at risk patients. “At this point, an intervention could relate to lifestyle changes and involve highlighting to the patient that the morbidity they have already accumulated is suggestive of diabetes risk,” he said, adding that, “they may have dyslipidemia, hypertension, and most often excess weight so annual checks of their HbA1c, weight management, and blood pressure would need checking,” he explained.

Moderator Coen Stehouwer, MD, professor of internal medicine at Maastricht University, the Netherlands, commented, “Before clinical diagnosis of type 2 diabetes there is often a lengthy period of undiagnosed disease and before that, prediabetes, because glucose can be abnormal up to 10 years prior to clinical diagnosis.”

But he added that, “It’s not entirely clear whether the rise seen before clinical diagnosis in this study correlates with undiagnosed diabetes or prediabetes or even if it precedes type 2 diabetes – it might be because inflammation is a common origin for type 2 diabetes and various comorbidities. This might explain how they go together.”
 

Longitudinal study 25 years before and 25 years after type 2 diagnosis

Dr. Heald presented the findings at a session on inflammation in diabetes at the annual meeting of the European Association for the Study of Diabetes. The work was also published in Diabetes Therapy.

The researchers wanted to investigate the pattern of comorbidities in the years and decades prior to a diagnosis of type 2 diabetes as well as after: “With the database we used, called DARE [Diabetes Alliance for Research in England], we are able to explore phenomena longitudinally going right back to the beginning of their digital health records, looking at phenotypes over time.”

By mapping significant health issues in people who went on to develop type 2 diabetes alongside those that did not, Dr. Heald managed to develop a continuum spanning 25 years prior and 25 years after diagnosis of type 2 diabetes. The researchers also examined relationships between sociodemographic factors and longitudinal health outcomes of relevance to cardiac conditions and lower respiratory tract infections. His talk in Hamburg primarily addressed clinical phenotypes before the point of diagnosis.

Data were drawn from 1,932 people with (1,196) and without (736) type 2 diabetes. Participants in both groups were aged 66-67 years, 43%-46% were women, age at diagnosis was 50-52 years, and participants lived in Greater Manchester, United Kingdom.

In the years leading up to type 2 diagnosis, individuals consistently exhibited a considerable increase in several clinical phenotypes, reported Dr. Heald. Of note, he added, “immediately prior to type 2 diagnosis, there was a significantly greater proportion of hypertension at 35%, respiratory tract infection at 34%, heart disease at 17%, ear, nose, and throat infection at 19%, and asthma at 12%. And by comparison, the corresponding disease trajectory in matched controls was much less dramatic.”

“There is a huge difference in people who went on to receive a diagnosis of type 2 diabetes and those who did not, and not just what we’d expect – so hypertension for example or manifestations of renal disease, but importantly inflammatory disorders are more common,” he emphasized.

In addition, a larger signal for ischemic heart disease was seen just before type 2 diabetes diagnosis.

These data suggest that longitudinal clinical histories prior to a diagnosis of type 2 diabetes might offer new information, both genetic and nongenetic, about development of type 2 diabetes in relation to comorbidities.

After type 2 diabetes diagnosis, the proportion of people exhibiting coronary artery disease, hypertension, chronic kidney disease, retinopathy, and infections climbed rapidly before plateauing, reported Dr. Heald. “We also know that individuals with coronary artery disease are more highly represented in socially disadvantaged groups, and this is borne out in the data at 25 years prior and after type 2 diagnosis.”

Dr. Heald has received speaker fees or contributed to advisory boards from Lilly, AstraZeneca, Janssen, Bristol-Myers Squibb, Besins, Bayer, Sanofi, and Recordati. Research grants from Novo Nordisk, Pfizer, and Besins. Professor Stehouwer has declared no relevant conflicts.

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

Respiratory tract infections and asthma are 10 times more prevalent at type 2 diabetes diagnosis, compared with matched controls without a diagnosis, shows a longitudinal study looking at comorbidities both 25 years before and 25 years after a type 2 diabetes diagnosis.

About 40% of people had respiratory tract infections at the time of diagnosis with type 2 diabetes, compared with 4% who were not diagnosed. Likewise, ear, nose, and throat infections were present in 20% of people at type 2 diabetes diagnosis, compared with around 2% who were not diagnosed. A similar pattern was seen with asthma.

Taken together, the data suggest that subacute inflammation manifesting in asthma as well as the onset of asthma or an acute infection may be a precursor to a type 2 diabetes diagnosis.

“We have also found that in the years prior to diagnosis, there are associations with infections and inflammatory disorders to a much greater degree than in those people who do not get a diabetes diagnosis but who have very similar demographics,” Adrian Heald, MD, study lead and diabetes consultant from Salford (England) Royal Hospital, said in an interview.

Five years prior to diagnosis, respiratory tract infections were documented in around 23% of patients who were later diagnosed with type 2 diabetes versus 2.5% in those not diagnosed, and a similar pattern was seen for ear, nose, and throat infections and asthma. The findings suggest that patients reporting infections, in addition to other known risk factors for type 2 diabetes, might benefit from diabetes tests and early interventions, if needed.

“These novel insights offer a fascinating and fresh perspective on the onset and natural progression to type 2 diabetes and beyond, suggesting an early phase of inflammation-related disease activity long before any clinical diagnosis of type 2 diabetes is made.”

Dr. Heald points out that clinicians may intervene to stave off progression to a type 2 diabetes diagnosis in at risk patients. “At this point, an intervention could relate to lifestyle changes and involve highlighting to the patient that the morbidity they have already accumulated is suggestive of diabetes risk,” he said, adding that, “they may have dyslipidemia, hypertension, and most often excess weight so annual checks of their HbA1c, weight management, and blood pressure would need checking,” he explained.

Moderator Coen Stehouwer, MD, professor of internal medicine at Maastricht University, the Netherlands, commented, “Before clinical diagnosis of type 2 diabetes there is often a lengthy period of undiagnosed disease and before that, prediabetes, because glucose can be abnormal up to 10 years prior to clinical diagnosis.”

But he added that, “It’s not entirely clear whether the rise seen before clinical diagnosis in this study correlates with undiagnosed diabetes or prediabetes or even if it precedes type 2 diabetes – it might be because inflammation is a common origin for type 2 diabetes and various comorbidities. This might explain how they go together.”
 

Longitudinal study 25 years before and 25 years after type 2 diagnosis

Dr. Heald presented the findings at a session on inflammation in diabetes at the annual meeting of the European Association for the Study of Diabetes. The work was also published in Diabetes Therapy.

The researchers wanted to investigate the pattern of comorbidities in the years and decades prior to a diagnosis of type 2 diabetes as well as after: “With the database we used, called DARE [Diabetes Alliance for Research in England], we are able to explore phenomena longitudinally going right back to the beginning of their digital health records, looking at phenotypes over time.”

By mapping significant health issues in people who went on to develop type 2 diabetes alongside those that did not, Dr. Heald managed to develop a continuum spanning 25 years prior and 25 years after diagnosis of type 2 diabetes. The researchers also examined relationships between sociodemographic factors and longitudinal health outcomes of relevance to cardiac conditions and lower respiratory tract infections. His talk in Hamburg primarily addressed clinical phenotypes before the point of diagnosis.

Data were drawn from 1,932 people with (1,196) and without (736) type 2 diabetes. Participants in both groups were aged 66-67 years, 43%-46% were women, age at diagnosis was 50-52 years, and participants lived in Greater Manchester, United Kingdom.

In the years leading up to type 2 diagnosis, individuals consistently exhibited a considerable increase in several clinical phenotypes, reported Dr. Heald. Of note, he added, “immediately prior to type 2 diagnosis, there was a significantly greater proportion of hypertension at 35%, respiratory tract infection at 34%, heart disease at 17%, ear, nose, and throat infection at 19%, and asthma at 12%. And by comparison, the corresponding disease trajectory in matched controls was much less dramatic.”

“There is a huge difference in people who went on to receive a diagnosis of type 2 diabetes and those who did not, and not just what we’d expect – so hypertension for example or manifestations of renal disease, but importantly inflammatory disorders are more common,” he emphasized.

In addition, a larger signal for ischemic heart disease was seen just before type 2 diabetes diagnosis.

These data suggest that longitudinal clinical histories prior to a diagnosis of type 2 diabetes might offer new information, both genetic and nongenetic, about development of type 2 diabetes in relation to comorbidities.

After type 2 diabetes diagnosis, the proportion of people exhibiting coronary artery disease, hypertension, chronic kidney disease, retinopathy, and infections climbed rapidly before plateauing, reported Dr. Heald. “We also know that individuals with coronary artery disease are more highly represented in socially disadvantaged groups, and this is borne out in the data at 25 years prior and after type 2 diagnosis.”

Dr. Heald has received speaker fees or contributed to advisory boards from Lilly, AstraZeneca, Janssen, Bristol-Myers Squibb, Besins, Bayer, Sanofi, and Recordati. Research grants from Novo Nordisk, Pfizer, and Besins. Professor Stehouwer has declared no relevant conflicts.

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

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Precision medicine takes individual approach to diabetes

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An international consensus report on precision diabetes medicine aims to further move the field from aspirational to actionable with a person-first focus.

“Diabetes recommendations often focus on what works well for the average person. However, because diabetes is an incredibly heterogeneous disease, few people are Mr. or Mrs. ‘average’ and one-size-fits-all approaches fail many people in need. Precision medicine seeks to address this major problem,” said Precision Medicine in Diabetes Initiative (PDMI) cochair Paul Franks, PhD, MPhil, head of the department of translational medicine at the Novo Nordisk Foundation in Denmark.

The report is the second from the joint American Diabetes Association/European Association for the Study of Diabetes PDMI, a consortium organized in 2018 with the aim of addressing “the untenable health and economic burdens of diabetes prevention and care.”

Based on findings from 15 systematic reviews and expert opinions, the new statement covers the key precision medicine pillars of prevention, diagnosis, treatment, and prognosis for each of four major recognized forms of diabetes: monogenic, gestational, type 1, and type 2. It addresses clinical translation of precision medicine research, including near-term actionable measures. Working groups were tasked with defining the key research questions that need to be addressed for precision diabetes medicine to be implemented into clinical practice by 2030.

Dr. Franks noted that “precision medicine seeks to improve diabetes prevention and care by combining data about a person’s health or disease state and response to medications. The aim is to tailor the advice given about diabetes prevention or treatment to the person in question, rather than having them make do with generic advice. Precision medicine very much focuses on treating the person and not the disease.”

A 90-minute symposium summarizing the report was presented at the annual meeting of the European Association for the Study of Diabetes. An executive summary was simultaneously published in the journal Nature Medicine. Four additional complementary papers, covering cardiometabolic disease precision medicine, diabetes heterogeneity, precision medicine of obesity, and precision cardiometabolic medicine in low- and middle-income countries, were published separately in The Lancet Diabetes & Endocrinology.

In a comment, Kamlesh Khunti, MD, professor of primary care diabetes and vascular medicine at the University of Leicester, England, called the new report “fantastic collaborative work.”

However, Dr. Khunti said, “I think at the moment we’re at the discovery stage of precision medicine. The clinical utility of that, we’ll have to see over the years.”

Dr. Khunti also pointed out: “A lot of the work done in precision medicine has been on specific diseases, like diabetes and cardiovascular disease. But, 30% of people don’t just have one disease, they have multiple long-term conditions. I think we need to start thinking about that now, rather than single conditions, because we want to look at drug targets that will hit multiple long-term conditions rather than one single condition.”
 

Currently, a dearth of data

Even just within diabetes, there is a dearth of quality data. In fact, Dr. Franks told this news organization, there has only been one precision medicine trial in diabetes, called TriMaster, comparing individual responses to three different second-line treatments for type 2 diabetes after metformin. “The problem with that trial is that the second-line medications it investigated aren’t widely prescribed now. The trial was designed back in 2014. It took a long time, then there was COVID, and by the time it was published too much time had elapsed and it was already out of date.”

Ideally, to make this effort current, Dr. Franks said, “is to get drug companies to implement these trials into their development pipelines. If you think about it, it’s far more efficient to implement precision medicine early in the drug development process than late, because when you do it late you end up having to do lots of comparisons of different possibilities. When you do it early you sort out those comparisons as part of the development process, so it really comes down to companies being willing to do that and regulators being willing to accept results from those trials. That’s another challenge, which is why we stress regulatory engagement as a key thing.”

In the future, he said, using the second-line type 2 diabetes drug as an example, when a person is diagnosed with type 2 diabetes they might automatically be given a companion diagnostic that’s more sophisticated and more precise than current ways of defining cardiovascular risk to better predict which individuals are more likely to experience a cardiovascular event.

This concept, referred to as “precision diagnostics,” is a “core driver of precision medicine,” Dr. Franks said. “If we can get a higher predictive accuracy on cardiovascular outcomes in people with diabetes, essentially treatment allocation is likely to be more precise too, because you’re not treating people you don’t need to treat and you’re not missing people you should have treated. I think that’s probably how it will work out.”
 

‘Studying diverse populations benefits everyone’

An important component emphasized in the report is the lack of “relevant, high-quality research in people of non-European ancestry, hindering the development and implementation of precision diabetes medicine in many of the most heavily burdened populations worldwide.”

That specific issue was addressed during the symposium by Shivani Misra, MBBS, PhD clinical senior lecturer in diabetes and endocrinology at Imperial College, London, and the lead author of the separate complementary paper on the topic.

Dr. Misra argued against the notion that precision medicine is only for wealthy countries, noting that diabetes and other noncommunicable diseases are becoming major health problems in low- and middle-income countries. “Resource-restricted settings may derive the greatest benefits from precision medicine,” she said. “Studying diverse populations benefits everyone.”

And worldwide, she noted, “the right drug for the right person will improve cost-effectiveness in the long-term.”

Dr. Franks is an employee of the Novo Nordisk Foundation, a “purely philanthropic enterprise-owning foundation” with a portfolio of 151 companies. He has received consultancy fees from Zoe Ltd., Eli Lilly, and Novo Nordisk, and research funding from multiple pharmaceutical companies. Dr. Khunti has acted as a consultant, speaker, or received grants for investigator-initiated studies from AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie/Menarini Group, Janssen, and Napp. Dr. Misra has received speaker fees from Sanofi and ABCD and an investigator-initiated research grant from Dexcom, and is a trustee for the Diabetes Research and Wellness Foundation.

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

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An international consensus report on precision diabetes medicine aims to further move the field from aspirational to actionable with a person-first focus.

“Diabetes recommendations often focus on what works well for the average person. However, because diabetes is an incredibly heterogeneous disease, few people are Mr. or Mrs. ‘average’ and one-size-fits-all approaches fail many people in need. Precision medicine seeks to address this major problem,” said Precision Medicine in Diabetes Initiative (PDMI) cochair Paul Franks, PhD, MPhil, head of the department of translational medicine at the Novo Nordisk Foundation in Denmark.

The report is the second from the joint American Diabetes Association/European Association for the Study of Diabetes PDMI, a consortium organized in 2018 with the aim of addressing “the untenable health and economic burdens of diabetes prevention and care.”

Based on findings from 15 systematic reviews and expert opinions, the new statement covers the key precision medicine pillars of prevention, diagnosis, treatment, and prognosis for each of four major recognized forms of diabetes: monogenic, gestational, type 1, and type 2. It addresses clinical translation of precision medicine research, including near-term actionable measures. Working groups were tasked with defining the key research questions that need to be addressed for precision diabetes medicine to be implemented into clinical practice by 2030.

Dr. Franks noted that “precision medicine seeks to improve diabetes prevention and care by combining data about a person’s health or disease state and response to medications. The aim is to tailor the advice given about diabetes prevention or treatment to the person in question, rather than having them make do with generic advice. Precision medicine very much focuses on treating the person and not the disease.”

A 90-minute symposium summarizing the report was presented at the annual meeting of the European Association for the Study of Diabetes. An executive summary was simultaneously published in the journal Nature Medicine. Four additional complementary papers, covering cardiometabolic disease precision medicine, diabetes heterogeneity, precision medicine of obesity, and precision cardiometabolic medicine in low- and middle-income countries, were published separately in The Lancet Diabetes & Endocrinology.

In a comment, Kamlesh Khunti, MD, professor of primary care diabetes and vascular medicine at the University of Leicester, England, called the new report “fantastic collaborative work.”

However, Dr. Khunti said, “I think at the moment we’re at the discovery stage of precision medicine. The clinical utility of that, we’ll have to see over the years.”

Dr. Khunti also pointed out: “A lot of the work done in precision medicine has been on specific diseases, like diabetes and cardiovascular disease. But, 30% of people don’t just have one disease, they have multiple long-term conditions. I think we need to start thinking about that now, rather than single conditions, because we want to look at drug targets that will hit multiple long-term conditions rather than one single condition.”
 

Currently, a dearth of data

Even just within diabetes, there is a dearth of quality data. In fact, Dr. Franks told this news organization, there has only been one precision medicine trial in diabetes, called TriMaster, comparing individual responses to three different second-line treatments for type 2 diabetes after metformin. “The problem with that trial is that the second-line medications it investigated aren’t widely prescribed now. The trial was designed back in 2014. It took a long time, then there was COVID, and by the time it was published too much time had elapsed and it was already out of date.”

Ideally, to make this effort current, Dr. Franks said, “is to get drug companies to implement these trials into their development pipelines. If you think about it, it’s far more efficient to implement precision medicine early in the drug development process than late, because when you do it late you end up having to do lots of comparisons of different possibilities. When you do it early you sort out those comparisons as part of the development process, so it really comes down to companies being willing to do that and regulators being willing to accept results from those trials. That’s another challenge, which is why we stress regulatory engagement as a key thing.”

In the future, he said, using the second-line type 2 diabetes drug as an example, when a person is diagnosed with type 2 diabetes they might automatically be given a companion diagnostic that’s more sophisticated and more precise than current ways of defining cardiovascular risk to better predict which individuals are more likely to experience a cardiovascular event.

This concept, referred to as “precision diagnostics,” is a “core driver of precision medicine,” Dr. Franks said. “If we can get a higher predictive accuracy on cardiovascular outcomes in people with diabetes, essentially treatment allocation is likely to be more precise too, because you’re not treating people you don’t need to treat and you’re not missing people you should have treated. I think that’s probably how it will work out.”
 

‘Studying diverse populations benefits everyone’

An important component emphasized in the report is the lack of “relevant, high-quality research in people of non-European ancestry, hindering the development and implementation of precision diabetes medicine in many of the most heavily burdened populations worldwide.”

That specific issue was addressed during the symposium by Shivani Misra, MBBS, PhD clinical senior lecturer in diabetes and endocrinology at Imperial College, London, and the lead author of the separate complementary paper on the topic.

Dr. Misra argued against the notion that precision medicine is only for wealthy countries, noting that diabetes and other noncommunicable diseases are becoming major health problems in low- and middle-income countries. “Resource-restricted settings may derive the greatest benefits from precision medicine,” she said. “Studying diverse populations benefits everyone.”

And worldwide, she noted, “the right drug for the right person will improve cost-effectiveness in the long-term.”

Dr. Franks is an employee of the Novo Nordisk Foundation, a “purely philanthropic enterprise-owning foundation” with a portfolio of 151 companies. He has received consultancy fees from Zoe Ltd., Eli Lilly, and Novo Nordisk, and research funding from multiple pharmaceutical companies. Dr. Khunti has acted as a consultant, speaker, or received grants for investigator-initiated studies from AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie/Menarini Group, Janssen, and Napp. Dr. Misra has received speaker fees from Sanofi and ABCD and an investigator-initiated research grant from Dexcom, and is a trustee for the Diabetes Research and Wellness Foundation.

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

An international consensus report on precision diabetes medicine aims to further move the field from aspirational to actionable with a person-first focus.

“Diabetes recommendations often focus on what works well for the average person. However, because diabetes is an incredibly heterogeneous disease, few people are Mr. or Mrs. ‘average’ and one-size-fits-all approaches fail many people in need. Precision medicine seeks to address this major problem,” said Precision Medicine in Diabetes Initiative (PDMI) cochair Paul Franks, PhD, MPhil, head of the department of translational medicine at the Novo Nordisk Foundation in Denmark.

The report is the second from the joint American Diabetes Association/European Association for the Study of Diabetes PDMI, a consortium organized in 2018 with the aim of addressing “the untenable health and economic burdens of diabetes prevention and care.”

Based on findings from 15 systematic reviews and expert opinions, the new statement covers the key precision medicine pillars of prevention, diagnosis, treatment, and prognosis for each of four major recognized forms of diabetes: monogenic, gestational, type 1, and type 2. It addresses clinical translation of precision medicine research, including near-term actionable measures. Working groups were tasked with defining the key research questions that need to be addressed for precision diabetes medicine to be implemented into clinical practice by 2030.

Dr. Franks noted that “precision medicine seeks to improve diabetes prevention and care by combining data about a person’s health or disease state and response to medications. The aim is to tailor the advice given about diabetes prevention or treatment to the person in question, rather than having them make do with generic advice. Precision medicine very much focuses on treating the person and not the disease.”

A 90-minute symposium summarizing the report was presented at the annual meeting of the European Association for the Study of Diabetes. An executive summary was simultaneously published in the journal Nature Medicine. Four additional complementary papers, covering cardiometabolic disease precision medicine, diabetes heterogeneity, precision medicine of obesity, and precision cardiometabolic medicine in low- and middle-income countries, were published separately in The Lancet Diabetes & Endocrinology.

In a comment, Kamlesh Khunti, MD, professor of primary care diabetes and vascular medicine at the University of Leicester, England, called the new report “fantastic collaborative work.”

However, Dr. Khunti said, “I think at the moment we’re at the discovery stage of precision medicine. The clinical utility of that, we’ll have to see over the years.”

Dr. Khunti also pointed out: “A lot of the work done in precision medicine has been on specific diseases, like diabetes and cardiovascular disease. But, 30% of people don’t just have one disease, they have multiple long-term conditions. I think we need to start thinking about that now, rather than single conditions, because we want to look at drug targets that will hit multiple long-term conditions rather than one single condition.”
 

Currently, a dearth of data

Even just within diabetes, there is a dearth of quality data. In fact, Dr. Franks told this news organization, there has only been one precision medicine trial in diabetes, called TriMaster, comparing individual responses to three different second-line treatments for type 2 diabetes after metformin. “The problem with that trial is that the second-line medications it investigated aren’t widely prescribed now. The trial was designed back in 2014. It took a long time, then there was COVID, and by the time it was published too much time had elapsed and it was already out of date.”

Ideally, to make this effort current, Dr. Franks said, “is to get drug companies to implement these trials into their development pipelines. If you think about it, it’s far more efficient to implement precision medicine early in the drug development process than late, because when you do it late you end up having to do lots of comparisons of different possibilities. When you do it early you sort out those comparisons as part of the development process, so it really comes down to companies being willing to do that and regulators being willing to accept results from those trials. That’s another challenge, which is why we stress regulatory engagement as a key thing.”

In the future, he said, using the second-line type 2 diabetes drug as an example, when a person is diagnosed with type 2 diabetes they might automatically be given a companion diagnostic that’s more sophisticated and more precise than current ways of defining cardiovascular risk to better predict which individuals are more likely to experience a cardiovascular event.

This concept, referred to as “precision diagnostics,” is a “core driver of precision medicine,” Dr. Franks said. “If we can get a higher predictive accuracy on cardiovascular outcomes in people with diabetes, essentially treatment allocation is likely to be more precise too, because you’re not treating people you don’t need to treat and you’re not missing people you should have treated. I think that’s probably how it will work out.”
 

‘Studying diverse populations benefits everyone’

An important component emphasized in the report is the lack of “relevant, high-quality research in people of non-European ancestry, hindering the development and implementation of precision diabetes medicine in many of the most heavily burdened populations worldwide.”

That specific issue was addressed during the symposium by Shivani Misra, MBBS, PhD clinical senior lecturer in diabetes and endocrinology at Imperial College, London, and the lead author of the separate complementary paper on the topic.

Dr. Misra argued against the notion that precision medicine is only for wealthy countries, noting that diabetes and other noncommunicable diseases are becoming major health problems in low- and middle-income countries. “Resource-restricted settings may derive the greatest benefits from precision medicine,” she said. “Studying diverse populations benefits everyone.”

And worldwide, she noted, “the right drug for the right person will improve cost-effectiveness in the long-term.”

Dr. Franks is an employee of the Novo Nordisk Foundation, a “purely philanthropic enterprise-owning foundation” with a portfolio of 151 companies. He has received consultancy fees from Zoe Ltd., Eli Lilly, and Novo Nordisk, and research funding from multiple pharmaceutical companies. Dr. Khunti has acted as a consultant, speaker, or received grants for investigator-initiated studies from AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Berlin-Chemie/Menarini Group, Janssen, and Napp. Dr. Misra has received speaker fees from Sanofi and ABCD and an investigator-initiated research grant from Dexcom, and is a trustee for the Diabetes Research and Wellness Foundation.

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

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Social media makes kids with type 1 diabetes feel less alone

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Fri, 10/06/2023 - 10:18

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

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After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

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The new word in liver disease: The story behind NAFLD’s rebranding as MASLD

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Thu, 10/05/2023 - 11:15

A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

 

 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

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A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

 

 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

 

 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

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CPAP adherence curbs severe cardiovascular disease outcomes

Article Type
Changed
Thu, 10/05/2023 - 09:20

Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

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Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

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Hormone therapy less effective in menopausal women with obesity

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Thu, 10/05/2023 - 11:17

Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

 

 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic
Dr. Stephanie S. Faubion

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

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Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

 

 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic
Dr. Stephanie S. Faubion

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m2 or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

 

 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic
Dr. Stephanie S. Faubion

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

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Enlarging pink patches after traveling

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Enlarging pink patches after traveling

Enlarging pink patches

The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.

While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.

Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.

If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.

The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1

This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.

Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1

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Enlarging pink patches

The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.

While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.

Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.

If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.

The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1

This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.

Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Enlarging pink patches

The patient’s multiple pink, subtly annular patches after recent travel to Lyme-endemic areas of the United States demonstrated a classic manifestation of disseminated Lyme disease. An enzyme-linked immunosorbent assay was positive for Borrelia burgdorferi IgM and IgG antibodies, confirming an acute infection.

While not usually necessary, skin biopsy shows a nonspecific perivascular cellular infiltrate that may be comprised of histiocytes, lymphocytes, and plasma cells. Spirochetes are not typically seen, but they may be identified with antibody-labeled or silver stains.

Lyme disease initially manifests as localized disease with erythema migrans, a targetoid lesion on the skin that appears at the site of the tick bite. This initial stage develops within the first few weeks of the bite and may be accompanied by fatigue and a low-grade fever.

If left untreated, the infection may progress to early disseminated disease, which occurs weeks to months after the initial bite. This second stage of Lyme disease manifests with multiple erythema migrans lesions on additional parts of the body, indicating spirochete dissemination through the bloodstream and lymphatic system. Early disseminated disease may also include borrelial lymphocytoma, Lyme neuroborreliosis, and cardiac conduction abnormalities such as AV block.

The third stage of Lyme disease, late Lyme disease, occurs months to years after an initial infection that has gone untreated. The key feature of this stage is arthritis, which tends to affect the knees and may be migratory in nature. Neurological symptoms such as encephalopathy and polyneuropathies may also develop. A minority of patients with late Lyme disease may develop acrodermatitis chronica atrophicans, a rash that typically occurs on the dorsal hands and feet as blue-red plaques that turn the affected skin atrophic.1

This patient was treated with a 3-week course of oral doxycycline 100 mg twice daily and was referred to an infectious disease specialist for further work-up of systemic symptoms, given the risk for cardiac pathology in disseminated Lyme disease.

Photo courtesy of Le Wen Chiu, MD. Text courtesy of Le Wen Chiu, MD, Department of Dermatology, University of New Mexico School of Medicine, Albuquerque, and Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1

References

1. Cardenas-de la Garza JA, De la Cruz-Valadez E, Ocampo-Candiani J, et al. Clinical spectrum of Lyme disease. Eur J Clin Microbiol Infect Dis. 2019;38:201-208. doi:10.1007/s10096-018-3417-1

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