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Check out our new Crohn’s disease clinician toolkit!
Have you ever wished you could access all of our Crohn’s disease resources in one place? We’ve compiled our Crohn’s disease clinical guidance, continuing education resources, patient education, and FAQs into one convenient toolkit.
Toolkit includes clinical guidance on:
- Role of biomarkers for the management of Crohn’s disease
- Medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease
- Diet and nutritional therapies in patients with IBD
Check it out at www.gastro.org/toolkit.
Have you ever wished you could access all of our Crohn’s disease resources in one place? We’ve compiled our Crohn’s disease clinical guidance, continuing education resources, patient education, and FAQs into one convenient toolkit.
Toolkit includes clinical guidance on:
- Role of biomarkers for the management of Crohn’s disease
- Medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease
- Diet and nutritional therapies in patients with IBD
Check it out at www.gastro.org/toolkit.
Have you ever wished you could access all of our Crohn’s disease resources in one place? We’ve compiled our Crohn’s disease clinical guidance, continuing education resources, patient education, and FAQs into one convenient toolkit.
Toolkit includes clinical guidance on:
- Role of biomarkers for the management of Crohn’s disease
- Medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease
- Diet and nutritional therapies in patients with IBD
Check it out at www.gastro.org/toolkit.
EMA’s JAK Inhibitor Warning Criteria May Affect Up to 80% of Patients With Rheumatoid Arthritis
LIVERPOOL, ENGLAND — Four in five people with rheumatoid arthritis (RA) fall into “at risk” categories for the initiation of Janus kinase (JAK) inhibitors set by the European Medicines Agency (EMA), according to data from the long-running British Society for Rheumatology (BSR) Biologics Register in RA (BSRBR-RA).
The EMA decided in January 2023 to implement measures to reduce the risk for serious side effects with JAK inhibitors in the treatment of chronic inflammatory diseases. The EMA’s recommendations advise that JAK inhibitors “should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past, and those at increased risk of cancer.” The guidance also says to use JAK inhibitors “with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism [VTE]) ... [and that] the doses should be reduced in patient groups who are at risk of VTE, cancer, or major cardiovascular problems, where possible.”
To gauge the potential impact of the EMA’s decision, researchers analyzed BSRBR-RA data from 1341 individuals with RA who had started treatment with a JAK inhibitor before the agency issued its new recommendations. Among these individuals, 1075 (80.2%) met ≥ 1 EMA risk criterion. Half (54%) were current or past smokers, 44% had an increased risk for major cardiovascular events such as heart attack or stroke, 39% were 65 years or older, and 10% had an increased risk for cancer.
Nearly half (49%) of the study population who met ≥ 1 EMA risk criterion had received only one (31%) or no (18%) prior biologic disease-modifying antirheumatic drug (bDMARD), Zixing Tian, a PhD student at the University of Manchester in England, reported at the annual meeting of the British Society for Rheumatology. Of the remainder, 23% had received two prior bDMARDs, and 28% had previously received three or more bDMARDs.
The work suggests that majority of people who are currently being treated with JAK inhibitors would probably not be advised to start treatment with a JAK inhibitor today, the researchers suggested in their abstract.
Considerable Implications
There are potentially two ways of interpreting these data, suggested Ken Baker, BMBCh, PhD, senior clinical fellow and honorary consultant rheumatologist at Newcastle University in Newcastle upon Tyne, England.
“One is that rheumatologists starting these treatments are throwing caution to the wind and ignoring all guidance,” Dr. Baker said.
“The second is perhaps that the EMA guidance is difficult to implement in practice when it involves lots of the comorbidities and risk factors that commonly affect patients with rheumatoid arthritis.”
Paul Emery, MD, Versus Arthritis professor of rheumatology and director of the Leeds Biomedical Research Centre at the University of Leeds in England, also commented on the findings.
“We are going to exclude practically all of our patients if we follow EMA,” Dr. Emery said. “The implications are considerable because if someone has a DVT [deep vein thrombosis] or an MI [myocardial infarction], when we included them with a risk factor, what’s the implication if they choose to sue you?”
Moreover, the bigger question is what to do with all the people who are already established on a JAK inhibitor, Dr. Emery said. Should patients now switch off their medication? Doing so may well leave them with a period of inflammation that may be more harmful than continuing the JAK inhibitor, he suggested.
Were Cautions Warranted?
Like the US Food and Drug Administration, the EMA has concerns over the use of JAK inhibitors because of the drugs’ potential to increase the risk for serious side effects such as VTE, major adverse cardiovascular events, cancer, and all-cause mortality relative to tumor necrosis factor–alpha inhibitors.
Initially, the EMA issued cautions that only related to the use of tofacitinib (Xeljanz), which was the first JAK inhibitor to gain approval for RA and other chronic inflammatory diseases in Europe, but this expanded to include baricitinib (Olumiant) and most recently any member of the drug class, including abrocitinib (Cibinqo), filgotinib (Jyseleca), and upadacitinib (Rinvoq).
The EMA has done a responsible job of looking at the available data and issuing cautions to protect the populations of patients who may be exposed to these drugs, Peter C. Taylor, BMBCh, PhD, told this news organization. However, they are also severely restricting the populations of patients who can be treated with them. “It’s a complicated situation,” he said.
Dr. Taylor, the Norman Collisson chair of musculoskeletal medicine at the University of Oxford in England, was not only involved in some of the major JAK inhibitor clinical trials but also privy to the EMA’s recent deliberations as an observer during the process. He noted that the EMA originally considered restricting the use of the drug class in patients older than 50 years but settled upon age 65 years and older.
Shared Decision
“The issue for benefit and risk is there for any drug we use,” said Dr. Taylor, noting that there are over-the-counter drugs that can be “far more dangerous” than JAK inhibitors in terms of cardiovascular risk.
“In my opinion, the really key thing is to be able to communicate the issues with integrity, in a manner that the patient understands, to make sure that the risk is acceptable to them,” Dr. Taylor said.
It is all about optimizing treatment for an individual and proactively managing any other factors that may increase their personal risk for unwanted effects, Maya Buch, MBChB, PhD, professor of rheumatology and honorary consultant rheumatologist at the University of Manchester, said during a debate at the meeting.
“We still have unmet needs for our patient population. Patients aren’t achieving the goals and endpoints that we need,” Dr. Buch said.
“Don’t lose sight of the positive attributes that we’ve seen with JAK inhibitors,” she advised.
“We presume we know what the patient thinks when it comes to a matter of risk assessment, but it is always about tailoring treatment to that individual, and we are sometimes surprised in terms of what the patients want, even in the face of apparent higher risk,” Dr. Buch added.
Judicious Use
Iain McInnes, MBChB, PhD, observed during the same debate that it was “hard to argue that drugs are generally unsafe when they have already been approved. It’s also challenging to suggest they are not useful when they are being used.”
Dr. McInnes, honorary consultant rheumatologist and vice principal and head of the College of Medical Veterinary & Life Sciences at the University of Glasgow in Scotland, pointed out that the EMA warnings assume that all JAK inhibitors are the same, but is that really the case? This is complex biochemistry, and could newer JAK inhibitors have an improved safety profile?
“There is no free ride in the immune system, and we should bear that in mind,” Dr. McInnes said. “These drugs work ... but we are absolutely flitting along the boundaries of the safety/efficacy window.”
Dr. McInnes told this news organization that clinicians do have to be cautious.
“There’s a paradox in that the very age group that the regulators are now asking us to be cautious about prescribing is pushing JAK inhibitors later and later in the disease course,” he said. This is a time when people would already have other risks for cardiovascular and other events.
“Overall, if used within the regulatory advice, Janus kinase inhibitors are a really useful drug class.”
The BSRBR-RA is funded by a grant from the BSR. The BSR currently receives funding from AbbVie, Amgen, Celltrion, Eli Lilly, Pfizer, Samsung Bioepis, Sanofi, and Sandoz and in the past from Hospira, Merck Sharp & Dohme (MSD), Roche, SOBI, and UCB. This income finances a wholly separate contract between the BSR and the University of Manchester to host the BSRBR-RA. All decisions concerning study design, data capture, analyses, interpretation, and publication are made autonomously of any industrial contribution. Ms. Tian had no conflicts of interest to report. Dr. Emery disclosed ties to AbbVie, Bristol Myers Squibb (BMS), Eli Lilly, Pfizer, MSD, Novartis, Roche, Sandoz, Samsung, and UCB. Dr. Taylor disclosed ties to AbbVie, Biogen, Eli Lilly, Fresenius, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer, Sanofi, Aqtual, and UCB. Dr. Buch disclosed ties to Gilead, AbbVie, Arxx Therapeutics, Boehringer Ingelheim, CESAS Medical, Galapagos, Gilead, MediStreams, and Pfizer. Dr. McInnes disclosed ties to AbbVie, AstraZeneca, Boehringer Ingelheim, Compugen, Cabaletta Bio, Causeway, Dexterra, Eli Lilly, Celgene, MoonLake, Pfizer, Novartis, Janssen, Roche, and UCB.
A version of this article appeared on Medscape.com .
LIVERPOOL, ENGLAND — Four in five people with rheumatoid arthritis (RA) fall into “at risk” categories for the initiation of Janus kinase (JAK) inhibitors set by the European Medicines Agency (EMA), according to data from the long-running British Society for Rheumatology (BSR) Biologics Register in RA (BSRBR-RA).
The EMA decided in January 2023 to implement measures to reduce the risk for serious side effects with JAK inhibitors in the treatment of chronic inflammatory diseases. The EMA’s recommendations advise that JAK inhibitors “should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past, and those at increased risk of cancer.” The guidance also says to use JAK inhibitors “with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism [VTE]) ... [and that] the doses should be reduced in patient groups who are at risk of VTE, cancer, or major cardiovascular problems, where possible.”
To gauge the potential impact of the EMA’s decision, researchers analyzed BSRBR-RA data from 1341 individuals with RA who had started treatment with a JAK inhibitor before the agency issued its new recommendations. Among these individuals, 1075 (80.2%) met ≥ 1 EMA risk criterion. Half (54%) were current or past smokers, 44% had an increased risk for major cardiovascular events such as heart attack or stroke, 39% were 65 years or older, and 10% had an increased risk for cancer.
Nearly half (49%) of the study population who met ≥ 1 EMA risk criterion had received only one (31%) or no (18%) prior biologic disease-modifying antirheumatic drug (bDMARD), Zixing Tian, a PhD student at the University of Manchester in England, reported at the annual meeting of the British Society for Rheumatology. Of the remainder, 23% had received two prior bDMARDs, and 28% had previously received three or more bDMARDs.
The work suggests that majority of people who are currently being treated with JAK inhibitors would probably not be advised to start treatment with a JAK inhibitor today, the researchers suggested in their abstract.
Considerable Implications
There are potentially two ways of interpreting these data, suggested Ken Baker, BMBCh, PhD, senior clinical fellow and honorary consultant rheumatologist at Newcastle University in Newcastle upon Tyne, England.
“One is that rheumatologists starting these treatments are throwing caution to the wind and ignoring all guidance,” Dr. Baker said.
“The second is perhaps that the EMA guidance is difficult to implement in practice when it involves lots of the comorbidities and risk factors that commonly affect patients with rheumatoid arthritis.”
Paul Emery, MD, Versus Arthritis professor of rheumatology and director of the Leeds Biomedical Research Centre at the University of Leeds in England, also commented on the findings.
“We are going to exclude practically all of our patients if we follow EMA,” Dr. Emery said. “The implications are considerable because if someone has a DVT [deep vein thrombosis] or an MI [myocardial infarction], when we included them with a risk factor, what’s the implication if they choose to sue you?”
Moreover, the bigger question is what to do with all the people who are already established on a JAK inhibitor, Dr. Emery said. Should patients now switch off their medication? Doing so may well leave them with a period of inflammation that may be more harmful than continuing the JAK inhibitor, he suggested.
Were Cautions Warranted?
Like the US Food and Drug Administration, the EMA has concerns over the use of JAK inhibitors because of the drugs’ potential to increase the risk for serious side effects such as VTE, major adverse cardiovascular events, cancer, and all-cause mortality relative to tumor necrosis factor–alpha inhibitors.
Initially, the EMA issued cautions that only related to the use of tofacitinib (Xeljanz), which was the first JAK inhibitor to gain approval for RA and other chronic inflammatory diseases in Europe, but this expanded to include baricitinib (Olumiant) and most recently any member of the drug class, including abrocitinib (Cibinqo), filgotinib (Jyseleca), and upadacitinib (Rinvoq).
The EMA has done a responsible job of looking at the available data and issuing cautions to protect the populations of patients who may be exposed to these drugs, Peter C. Taylor, BMBCh, PhD, told this news organization. However, they are also severely restricting the populations of patients who can be treated with them. “It’s a complicated situation,” he said.
Dr. Taylor, the Norman Collisson chair of musculoskeletal medicine at the University of Oxford in England, was not only involved in some of the major JAK inhibitor clinical trials but also privy to the EMA’s recent deliberations as an observer during the process. He noted that the EMA originally considered restricting the use of the drug class in patients older than 50 years but settled upon age 65 years and older.
Shared Decision
“The issue for benefit and risk is there for any drug we use,” said Dr. Taylor, noting that there are over-the-counter drugs that can be “far more dangerous” than JAK inhibitors in terms of cardiovascular risk.
“In my opinion, the really key thing is to be able to communicate the issues with integrity, in a manner that the patient understands, to make sure that the risk is acceptable to them,” Dr. Taylor said.
It is all about optimizing treatment for an individual and proactively managing any other factors that may increase their personal risk for unwanted effects, Maya Buch, MBChB, PhD, professor of rheumatology and honorary consultant rheumatologist at the University of Manchester, said during a debate at the meeting.
“We still have unmet needs for our patient population. Patients aren’t achieving the goals and endpoints that we need,” Dr. Buch said.
“Don’t lose sight of the positive attributes that we’ve seen with JAK inhibitors,” she advised.
“We presume we know what the patient thinks when it comes to a matter of risk assessment, but it is always about tailoring treatment to that individual, and we are sometimes surprised in terms of what the patients want, even in the face of apparent higher risk,” Dr. Buch added.
Judicious Use
Iain McInnes, MBChB, PhD, observed during the same debate that it was “hard to argue that drugs are generally unsafe when they have already been approved. It’s also challenging to suggest they are not useful when they are being used.”
Dr. McInnes, honorary consultant rheumatologist and vice principal and head of the College of Medical Veterinary & Life Sciences at the University of Glasgow in Scotland, pointed out that the EMA warnings assume that all JAK inhibitors are the same, but is that really the case? This is complex biochemistry, and could newer JAK inhibitors have an improved safety profile?
“There is no free ride in the immune system, and we should bear that in mind,” Dr. McInnes said. “These drugs work ... but we are absolutely flitting along the boundaries of the safety/efficacy window.”
Dr. McInnes told this news organization that clinicians do have to be cautious.
“There’s a paradox in that the very age group that the regulators are now asking us to be cautious about prescribing is pushing JAK inhibitors later and later in the disease course,” he said. This is a time when people would already have other risks for cardiovascular and other events.
“Overall, if used within the regulatory advice, Janus kinase inhibitors are a really useful drug class.”
The BSRBR-RA is funded by a grant from the BSR. The BSR currently receives funding from AbbVie, Amgen, Celltrion, Eli Lilly, Pfizer, Samsung Bioepis, Sanofi, and Sandoz and in the past from Hospira, Merck Sharp & Dohme (MSD), Roche, SOBI, and UCB. This income finances a wholly separate contract between the BSR and the University of Manchester to host the BSRBR-RA. All decisions concerning study design, data capture, analyses, interpretation, and publication are made autonomously of any industrial contribution. Ms. Tian had no conflicts of interest to report. Dr. Emery disclosed ties to AbbVie, Bristol Myers Squibb (BMS), Eli Lilly, Pfizer, MSD, Novartis, Roche, Sandoz, Samsung, and UCB. Dr. Taylor disclosed ties to AbbVie, Biogen, Eli Lilly, Fresenius, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer, Sanofi, Aqtual, and UCB. Dr. Buch disclosed ties to Gilead, AbbVie, Arxx Therapeutics, Boehringer Ingelheim, CESAS Medical, Galapagos, Gilead, MediStreams, and Pfizer. Dr. McInnes disclosed ties to AbbVie, AstraZeneca, Boehringer Ingelheim, Compugen, Cabaletta Bio, Causeway, Dexterra, Eli Lilly, Celgene, MoonLake, Pfizer, Novartis, Janssen, Roche, and UCB.
A version of this article appeared on Medscape.com .
LIVERPOOL, ENGLAND — Four in five people with rheumatoid arthritis (RA) fall into “at risk” categories for the initiation of Janus kinase (JAK) inhibitors set by the European Medicines Agency (EMA), according to data from the long-running British Society for Rheumatology (BSR) Biologics Register in RA (BSRBR-RA).
The EMA decided in January 2023 to implement measures to reduce the risk for serious side effects with JAK inhibitors in the treatment of chronic inflammatory diseases. The EMA’s recommendations advise that JAK inhibitors “should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past, and those at increased risk of cancer.” The guidance also says to use JAK inhibitors “with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism [VTE]) ... [and that] the doses should be reduced in patient groups who are at risk of VTE, cancer, or major cardiovascular problems, where possible.”
To gauge the potential impact of the EMA’s decision, researchers analyzed BSRBR-RA data from 1341 individuals with RA who had started treatment with a JAK inhibitor before the agency issued its new recommendations. Among these individuals, 1075 (80.2%) met ≥ 1 EMA risk criterion. Half (54%) were current or past smokers, 44% had an increased risk for major cardiovascular events such as heart attack or stroke, 39% were 65 years or older, and 10% had an increased risk for cancer.
Nearly half (49%) of the study population who met ≥ 1 EMA risk criterion had received only one (31%) or no (18%) prior biologic disease-modifying antirheumatic drug (bDMARD), Zixing Tian, a PhD student at the University of Manchester in England, reported at the annual meeting of the British Society for Rheumatology. Of the remainder, 23% had received two prior bDMARDs, and 28% had previously received three or more bDMARDs.
The work suggests that majority of people who are currently being treated with JAK inhibitors would probably not be advised to start treatment with a JAK inhibitor today, the researchers suggested in their abstract.
Considerable Implications
There are potentially two ways of interpreting these data, suggested Ken Baker, BMBCh, PhD, senior clinical fellow and honorary consultant rheumatologist at Newcastle University in Newcastle upon Tyne, England.
“One is that rheumatologists starting these treatments are throwing caution to the wind and ignoring all guidance,” Dr. Baker said.
“The second is perhaps that the EMA guidance is difficult to implement in practice when it involves lots of the comorbidities and risk factors that commonly affect patients with rheumatoid arthritis.”
Paul Emery, MD, Versus Arthritis professor of rheumatology and director of the Leeds Biomedical Research Centre at the University of Leeds in England, also commented on the findings.
“We are going to exclude practically all of our patients if we follow EMA,” Dr. Emery said. “The implications are considerable because if someone has a DVT [deep vein thrombosis] or an MI [myocardial infarction], when we included them with a risk factor, what’s the implication if they choose to sue you?”
Moreover, the bigger question is what to do with all the people who are already established on a JAK inhibitor, Dr. Emery said. Should patients now switch off their medication? Doing so may well leave them with a period of inflammation that may be more harmful than continuing the JAK inhibitor, he suggested.
Were Cautions Warranted?
Like the US Food and Drug Administration, the EMA has concerns over the use of JAK inhibitors because of the drugs’ potential to increase the risk for serious side effects such as VTE, major adverse cardiovascular events, cancer, and all-cause mortality relative to tumor necrosis factor–alpha inhibitors.
Initially, the EMA issued cautions that only related to the use of tofacitinib (Xeljanz), which was the first JAK inhibitor to gain approval for RA and other chronic inflammatory diseases in Europe, but this expanded to include baricitinib (Olumiant) and most recently any member of the drug class, including abrocitinib (Cibinqo), filgotinib (Jyseleca), and upadacitinib (Rinvoq).
The EMA has done a responsible job of looking at the available data and issuing cautions to protect the populations of patients who may be exposed to these drugs, Peter C. Taylor, BMBCh, PhD, told this news organization. However, they are also severely restricting the populations of patients who can be treated with them. “It’s a complicated situation,” he said.
Dr. Taylor, the Norman Collisson chair of musculoskeletal medicine at the University of Oxford in England, was not only involved in some of the major JAK inhibitor clinical trials but also privy to the EMA’s recent deliberations as an observer during the process. He noted that the EMA originally considered restricting the use of the drug class in patients older than 50 years but settled upon age 65 years and older.
Shared Decision
“The issue for benefit and risk is there for any drug we use,” said Dr. Taylor, noting that there are over-the-counter drugs that can be “far more dangerous” than JAK inhibitors in terms of cardiovascular risk.
“In my opinion, the really key thing is to be able to communicate the issues with integrity, in a manner that the patient understands, to make sure that the risk is acceptable to them,” Dr. Taylor said.
It is all about optimizing treatment for an individual and proactively managing any other factors that may increase their personal risk for unwanted effects, Maya Buch, MBChB, PhD, professor of rheumatology and honorary consultant rheumatologist at the University of Manchester, said during a debate at the meeting.
“We still have unmet needs for our patient population. Patients aren’t achieving the goals and endpoints that we need,” Dr. Buch said.
“Don’t lose sight of the positive attributes that we’ve seen with JAK inhibitors,” she advised.
“We presume we know what the patient thinks when it comes to a matter of risk assessment, but it is always about tailoring treatment to that individual, and we are sometimes surprised in terms of what the patients want, even in the face of apparent higher risk,” Dr. Buch added.
Judicious Use
Iain McInnes, MBChB, PhD, observed during the same debate that it was “hard to argue that drugs are generally unsafe when they have already been approved. It’s also challenging to suggest they are not useful when they are being used.”
Dr. McInnes, honorary consultant rheumatologist and vice principal and head of the College of Medical Veterinary & Life Sciences at the University of Glasgow in Scotland, pointed out that the EMA warnings assume that all JAK inhibitors are the same, but is that really the case? This is complex biochemistry, and could newer JAK inhibitors have an improved safety profile?
“There is no free ride in the immune system, and we should bear that in mind,” Dr. McInnes said. “These drugs work ... but we are absolutely flitting along the boundaries of the safety/efficacy window.”
Dr. McInnes told this news organization that clinicians do have to be cautious.
“There’s a paradox in that the very age group that the regulators are now asking us to be cautious about prescribing is pushing JAK inhibitors later and later in the disease course,” he said. This is a time when people would already have other risks for cardiovascular and other events.
“Overall, if used within the regulatory advice, Janus kinase inhibitors are a really useful drug class.”
The BSRBR-RA is funded by a grant from the BSR. The BSR currently receives funding from AbbVie, Amgen, Celltrion, Eli Lilly, Pfizer, Samsung Bioepis, Sanofi, and Sandoz and in the past from Hospira, Merck Sharp & Dohme (MSD), Roche, SOBI, and UCB. This income finances a wholly separate contract between the BSR and the University of Manchester to host the BSRBR-RA. All decisions concerning study design, data capture, analyses, interpretation, and publication are made autonomously of any industrial contribution. Ms. Tian had no conflicts of interest to report. Dr. Emery disclosed ties to AbbVie, Bristol Myers Squibb (BMS), Eli Lilly, Pfizer, MSD, Novartis, Roche, Sandoz, Samsung, and UCB. Dr. Taylor disclosed ties to AbbVie, Biogen, Eli Lilly, Fresenius, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer, Sanofi, Aqtual, and UCB. Dr. Buch disclosed ties to Gilead, AbbVie, Arxx Therapeutics, Boehringer Ingelheim, CESAS Medical, Galapagos, Gilead, MediStreams, and Pfizer. Dr. McInnes disclosed ties to AbbVie, AstraZeneca, Boehringer Ingelheim, Compugen, Cabaletta Bio, Causeway, Dexterra, Eli Lilly, Celgene, MoonLake, Pfizer, Novartis, Janssen, Roche, and UCB.
A version of this article appeared on Medscape.com .
FROM BSR 2024
From Stigma to Support: Raising Awareness of Pelvic Organ Prolapse
Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.
“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”
Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.
Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.
Doctors who diagnose POP agree that the issue is often off PCPs’ radar.
“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.
Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”
But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.
Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.
“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”
What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”
Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.
PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
Causes, Risk Factors, and Symptoms
Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.
“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.
With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.
POP has a range of risk factors:
- Increasing age, as muscle mass decreases and connective tissue hardens.
- Menopause.
- Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
- Multiple vaginal deliveries.
- Birthing large babies.
- Family history of pelvic organ prolapse (genetics can play a role in POP risk).
- Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
- Smoking (largely because of associated coughing).
- Chronic lung conditions that cause a lot of coughing.
- Chronic constipation or irritable bowel syndrome.
- Some types of high-impact activity, such as jogging or marathon running.
- Early menopause, for younger women.
- Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
- Higher body mass index.
- Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.
Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.
Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.
Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.
There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
Screening and Diagnosis
Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.
“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.
Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”
Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.
Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
Treatment: Physical Therapy, Pessary, and Surgery
No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.
Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.
Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.
“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.
The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.
“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”
PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.
Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.
The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.
One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.
Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.
“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.
Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.
Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.
“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.
*This story was updated on May 14, 2024.
Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.
“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”
Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.
Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.
Doctors who diagnose POP agree that the issue is often off PCPs’ radar.
“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.
Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”
But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.
Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.
“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”
What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”
Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.
PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
Causes, Risk Factors, and Symptoms
Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.
“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.
With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.
POP has a range of risk factors:
- Increasing age, as muscle mass decreases and connective tissue hardens.
- Menopause.
- Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
- Multiple vaginal deliveries.
- Birthing large babies.
- Family history of pelvic organ prolapse (genetics can play a role in POP risk).
- Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
- Smoking (largely because of associated coughing).
- Chronic lung conditions that cause a lot of coughing.
- Chronic constipation or irritable bowel syndrome.
- Some types of high-impact activity, such as jogging or marathon running.
- Early menopause, for younger women.
- Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
- Higher body mass index.
- Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.
Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.
Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.
Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.
There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
Screening and Diagnosis
Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.
“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.
Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”
Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.
Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
Treatment: Physical Therapy, Pessary, and Surgery
No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.
Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.
Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.
“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.
The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.
“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”
PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.
Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.
The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.
One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.
Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.
“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.
Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.
Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.
“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.
*This story was updated on May 14, 2024.
Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.
“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”
Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.
Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.
Doctors who diagnose POP agree that the issue is often off PCPs’ radar.
“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.
Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”
But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.
Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.
“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”
What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”
Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.
PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
Causes, Risk Factors, and Symptoms
Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.
“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.
With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.
POP has a range of risk factors:
- Increasing age, as muscle mass decreases and connective tissue hardens.
- Menopause.
- Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
- Multiple vaginal deliveries.
- Birthing large babies.
- Family history of pelvic organ prolapse (genetics can play a role in POP risk).
- Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
- Smoking (largely because of associated coughing).
- Chronic lung conditions that cause a lot of coughing.
- Chronic constipation or irritable bowel syndrome.
- Some types of high-impact activity, such as jogging or marathon running.
- Early menopause, for younger women.
- Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
- Higher body mass index.
- Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.
Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.
Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.
Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.
There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
Screening and Diagnosis
Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.
“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.
Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”
Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.
Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
Treatment: Physical Therapy, Pessary, and Surgery
No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.
Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.
Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.
“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.
The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.
“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”
PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.
Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.
The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.
One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.
Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.
“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.
Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.
Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.
“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.
*This story was updated on May 14, 2024.
Multidisciplinary Team Develops New Guidelines for Sjögren-Related Neuropathy
New guidelines to manage peripheral neuropathy related to Sjögren disease have been developed by a multidisciplinary team of physicians from across medicine.
The guidelines will provide an evidence-based resource for the assessment, diagnosis, and treatment of various peripheral neuropathies related to the disorder.
Up until now, the field has been “haphazard and chaotic,” lead author George Sarka, MD, DrPH, MPH, director of the CME Committee for MemorialCare, Saddleback Medical Center, Laguna Hills, California, and member of the Sjögren Foundation PNS Guidelines Topic Review Group (TRG), told this news organization.
Dr. Sarka discussed the initiative at the American Academy of Neurology 2024 annual meeting.
Severe, Complex Illness
Sjögren disease is the second most common autoimmune rheumatic disorder after rheumatoid arthritis, affecting an estimated 4 million Americans. Women make up most of the patient population at a ratio of 9:1.
The condition typically affects the mucous membranes and moisture-secreting glands of the eyes and mouth, resulting in decreased tears and saliva. But peripheral nervous system (PNS) manifestations often precede these symptoms and can occur in up to 60% of Sjögren disease cases.
“Traditionally, Sjögren’s was looked at as a dry eye and dry mouth disease, but we realize now that it’s so much broader than that,” said Dr. Sarka. “It’s a severe, systemic, and complex illness that can affect any body organ or system, and the nervous system is frequently affected.”
PNS manifestations cause more than mere discomfort; they can lead to diagnostic and management challenges, costly treatments, and diminished quality of life.
Getting a proper diagnosis goes a long way toward improving the quality of life for these patients, Steven Mandel, MD, clinical professor of neurology at the Zucker School of Medicine at Hofstra-Northwell, adjunct clinical professor of medicine at NY Medical College, New York City, and member of the TRG, told this news organization.
The problem is, doctors don’t always think an autoimmune disorder is causing the symptoms, said Dr. Sarka. “There’s an old adage in neurology that if you don’t think about it, you’re going to miss it; you have to ask, and that’s what we’re trying to get people to do.”
The condition often accompanies other immune system disorders such as rheumatoid arthritis and lupus. But as patients are referred back and forth between ophthalmologists, rheumatologists, and neurologists, the condition is often missed. “It could be 4 or 5 years before a definitive diagnosis of Sjögren’s is made,” said Dr. Sarka.
He believes the education system is partly to blame. “Medical schools have been very deficient in teaching people about recognizing Sjögren disease.”
That leaves many physicians at a loss about “what to do with these patients when they walk in the door,” said Dr. Mandel. “They don’t know how to manage them; they don’t know how to diagnose them; and they don’t know how to treat them.”
Developing guidelines with multispecialty collaboration was “absolutely critical” in addressing this knowledge gap, Dr. Mandel added. That process involved “a very rigorous and transparent methodology so that it would be accepted by all the professionals involved in Sjögren’s,” he said.
The process took 3 years and involved amassing and grading the evidence, getting consensus from committee members, developing recommendations, and getting feedback and external review.
Scant Evidence
An early literature search revealed very little evidence on PNS manifestations in patients with Sjögren disease, so the guideline committee “leaned very heavily on expert opinion” to develop recommendations, Kathy Hammitt, MA, vice president of Medical and Scientific Affairs, Sjögren’s Foundation, told this news organization.
The literature search also showed different terms are used to describe PNS, “which is where the chaos comes in,” said Dr. Sarka.
Experts from different specialties worked together to define and align nomenclature used by various specialists. They developed definitions for seven PNS categories including mononeuropathy, large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, ganglionopathy, vasculitis neuropathy, and autoimmune nervous system neuropathy.
The guidelines pertaining to PNS manifestations encompass a spectrum of neurologic abnormalities, including cranial neuropathies (trigeminal neuropathy or acute facial neuropathy), polyneuropathies (large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, vasculitis neuropathy, or ganglionopathy), and autonomic nervous system (ANS) neuropathies (postural tachycardia, orthostatic hypotension, or autonomic dysfunction).
Key Steps
The guidelines address two key steps for each PNS manifestation — the workup and evaluation of patients with suspected ANS manifestation including standard evaluations, diagnostic tests, and treatment. The experts developed 31 best practices for diagnosis and workup and 20 treatment recommendations.
Initial assessment of potential ANS involvement includes asking patients about orthostatic postural lightheadedness and difficulties with digestion, urination, sweating, and sexual function.
Treatment of autoimmune diseases typically focuses on relieving symptoms and can include steroids, the anticonvulsant gabapentin, the monoclonal antibody rituximab, and intravenous immunoglobulin. “The type of neuropathy will mandate or suggest certain therapies over others,” said Dr. Sarka, adding that a patient can have more than one neuropathy.
Therapeutics for Sjögren disease is another example of an area that has been “very haphazard,” he added.
The guidelines are aimed not just at specialists but also at general practitioners who treat many of these patients. But Dr. Hammitt emphasized that neurologists can be “instrumental” in identifying Sjögren disease in patients with PNS symptoms.
“Our hope is that specialists — in this case, neurologists — will recognize the potential for this condition in their PNS patients and ensure referral to a rheumatologist or knowledgeable family practitioner to manage overall care.”
The committee will soon submit its manuscript to the AAN for publication.
“Once published, we will have a robust dissemination strategy to ensure that providers, patients, and policymakers are aware of, and use, this very valuable resource,” said Dr. Hammitt.
No conflicts of interest were reported.
A version of this article appeared on Medscape.com.
New guidelines to manage peripheral neuropathy related to Sjögren disease have been developed by a multidisciplinary team of physicians from across medicine.
The guidelines will provide an evidence-based resource for the assessment, diagnosis, and treatment of various peripheral neuropathies related to the disorder.
Up until now, the field has been “haphazard and chaotic,” lead author George Sarka, MD, DrPH, MPH, director of the CME Committee for MemorialCare, Saddleback Medical Center, Laguna Hills, California, and member of the Sjögren Foundation PNS Guidelines Topic Review Group (TRG), told this news organization.
Dr. Sarka discussed the initiative at the American Academy of Neurology 2024 annual meeting.
Severe, Complex Illness
Sjögren disease is the second most common autoimmune rheumatic disorder after rheumatoid arthritis, affecting an estimated 4 million Americans. Women make up most of the patient population at a ratio of 9:1.
The condition typically affects the mucous membranes and moisture-secreting glands of the eyes and mouth, resulting in decreased tears and saliva. But peripheral nervous system (PNS) manifestations often precede these symptoms and can occur in up to 60% of Sjögren disease cases.
“Traditionally, Sjögren’s was looked at as a dry eye and dry mouth disease, but we realize now that it’s so much broader than that,” said Dr. Sarka. “It’s a severe, systemic, and complex illness that can affect any body organ or system, and the nervous system is frequently affected.”
PNS manifestations cause more than mere discomfort; they can lead to diagnostic and management challenges, costly treatments, and diminished quality of life.
Getting a proper diagnosis goes a long way toward improving the quality of life for these patients, Steven Mandel, MD, clinical professor of neurology at the Zucker School of Medicine at Hofstra-Northwell, adjunct clinical professor of medicine at NY Medical College, New York City, and member of the TRG, told this news organization.
The problem is, doctors don’t always think an autoimmune disorder is causing the symptoms, said Dr. Sarka. “There’s an old adage in neurology that if you don’t think about it, you’re going to miss it; you have to ask, and that’s what we’re trying to get people to do.”
The condition often accompanies other immune system disorders such as rheumatoid arthritis and lupus. But as patients are referred back and forth between ophthalmologists, rheumatologists, and neurologists, the condition is often missed. “It could be 4 or 5 years before a definitive diagnosis of Sjögren’s is made,” said Dr. Sarka.
He believes the education system is partly to blame. “Medical schools have been very deficient in teaching people about recognizing Sjögren disease.”
That leaves many physicians at a loss about “what to do with these patients when they walk in the door,” said Dr. Mandel. “They don’t know how to manage them; they don’t know how to diagnose them; and they don’t know how to treat them.”
Developing guidelines with multispecialty collaboration was “absolutely critical” in addressing this knowledge gap, Dr. Mandel added. That process involved “a very rigorous and transparent methodology so that it would be accepted by all the professionals involved in Sjögren’s,” he said.
The process took 3 years and involved amassing and grading the evidence, getting consensus from committee members, developing recommendations, and getting feedback and external review.
Scant Evidence
An early literature search revealed very little evidence on PNS manifestations in patients with Sjögren disease, so the guideline committee “leaned very heavily on expert opinion” to develop recommendations, Kathy Hammitt, MA, vice president of Medical and Scientific Affairs, Sjögren’s Foundation, told this news organization.
The literature search also showed different terms are used to describe PNS, “which is where the chaos comes in,” said Dr. Sarka.
Experts from different specialties worked together to define and align nomenclature used by various specialists. They developed definitions for seven PNS categories including mononeuropathy, large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, ganglionopathy, vasculitis neuropathy, and autoimmune nervous system neuropathy.
The guidelines pertaining to PNS manifestations encompass a spectrum of neurologic abnormalities, including cranial neuropathies (trigeminal neuropathy or acute facial neuropathy), polyneuropathies (large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, vasculitis neuropathy, or ganglionopathy), and autonomic nervous system (ANS) neuropathies (postural tachycardia, orthostatic hypotension, or autonomic dysfunction).
Key Steps
The guidelines address two key steps for each PNS manifestation — the workup and evaluation of patients with suspected ANS manifestation including standard evaluations, diagnostic tests, and treatment. The experts developed 31 best practices for diagnosis and workup and 20 treatment recommendations.
Initial assessment of potential ANS involvement includes asking patients about orthostatic postural lightheadedness and difficulties with digestion, urination, sweating, and sexual function.
Treatment of autoimmune diseases typically focuses on relieving symptoms and can include steroids, the anticonvulsant gabapentin, the monoclonal antibody rituximab, and intravenous immunoglobulin. “The type of neuropathy will mandate or suggest certain therapies over others,” said Dr. Sarka, adding that a patient can have more than one neuropathy.
Therapeutics for Sjögren disease is another example of an area that has been “very haphazard,” he added.
The guidelines are aimed not just at specialists but also at general practitioners who treat many of these patients. But Dr. Hammitt emphasized that neurologists can be “instrumental” in identifying Sjögren disease in patients with PNS symptoms.
“Our hope is that specialists — in this case, neurologists — will recognize the potential for this condition in their PNS patients and ensure referral to a rheumatologist or knowledgeable family practitioner to manage overall care.”
The committee will soon submit its manuscript to the AAN for publication.
“Once published, we will have a robust dissemination strategy to ensure that providers, patients, and policymakers are aware of, and use, this very valuable resource,” said Dr. Hammitt.
No conflicts of interest were reported.
A version of this article appeared on Medscape.com.
New guidelines to manage peripheral neuropathy related to Sjögren disease have been developed by a multidisciplinary team of physicians from across medicine.
The guidelines will provide an evidence-based resource for the assessment, diagnosis, and treatment of various peripheral neuropathies related to the disorder.
Up until now, the field has been “haphazard and chaotic,” lead author George Sarka, MD, DrPH, MPH, director of the CME Committee for MemorialCare, Saddleback Medical Center, Laguna Hills, California, and member of the Sjögren Foundation PNS Guidelines Topic Review Group (TRG), told this news organization.
Dr. Sarka discussed the initiative at the American Academy of Neurology 2024 annual meeting.
Severe, Complex Illness
Sjögren disease is the second most common autoimmune rheumatic disorder after rheumatoid arthritis, affecting an estimated 4 million Americans. Women make up most of the patient population at a ratio of 9:1.
The condition typically affects the mucous membranes and moisture-secreting glands of the eyes and mouth, resulting in decreased tears and saliva. But peripheral nervous system (PNS) manifestations often precede these symptoms and can occur in up to 60% of Sjögren disease cases.
“Traditionally, Sjögren’s was looked at as a dry eye and dry mouth disease, but we realize now that it’s so much broader than that,” said Dr. Sarka. “It’s a severe, systemic, and complex illness that can affect any body organ or system, and the nervous system is frequently affected.”
PNS manifestations cause more than mere discomfort; they can lead to diagnostic and management challenges, costly treatments, and diminished quality of life.
Getting a proper diagnosis goes a long way toward improving the quality of life for these patients, Steven Mandel, MD, clinical professor of neurology at the Zucker School of Medicine at Hofstra-Northwell, adjunct clinical professor of medicine at NY Medical College, New York City, and member of the TRG, told this news organization.
The problem is, doctors don’t always think an autoimmune disorder is causing the symptoms, said Dr. Sarka. “There’s an old adage in neurology that if you don’t think about it, you’re going to miss it; you have to ask, and that’s what we’re trying to get people to do.”
The condition often accompanies other immune system disorders such as rheumatoid arthritis and lupus. But as patients are referred back and forth between ophthalmologists, rheumatologists, and neurologists, the condition is often missed. “It could be 4 or 5 years before a definitive diagnosis of Sjögren’s is made,” said Dr. Sarka.
He believes the education system is partly to blame. “Medical schools have been very deficient in teaching people about recognizing Sjögren disease.”
That leaves many physicians at a loss about “what to do with these patients when they walk in the door,” said Dr. Mandel. “They don’t know how to manage them; they don’t know how to diagnose them; and they don’t know how to treat them.”
Developing guidelines with multispecialty collaboration was “absolutely critical” in addressing this knowledge gap, Dr. Mandel added. That process involved “a very rigorous and transparent methodology so that it would be accepted by all the professionals involved in Sjögren’s,” he said.
The process took 3 years and involved amassing and grading the evidence, getting consensus from committee members, developing recommendations, and getting feedback and external review.
Scant Evidence
An early literature search revealed very little evidence on PNS manifestations in patients with Sjögren disease, so the guideline committee “leaned very heavily on expert opinion” to develop recommendations, Kathy Hammitt, MA, vice president of Medical and Scientific Affairs, Sjögren’s Foundation, told this news organization.
The literature search also showed different terms are used to describe PNS, “which is where the chaos comes in,” said Dr. Sarka.
Experts from different specialties worked together to define and align nomenclature used by various specialists. They developed definitions for seven PNS categories including mononeuropathy, large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, ganglionopathy, vasculitis neuropathy, and autoimmune nervous system neuropathy.
The guidelines pertaining to PNS manifestations encompass a spectrum of neurologic abnormalities, including cranial neuropathies (trigeminal neuropathy or acute facial neuropathy), polyneuropathies (large fiber neuropathy, small fiber neuropathy, demyelinating polyradiculoneuropathy, vasculitis neuropathy, or ganglionopathy), and autonomic nervous system (ANS) neuropathies (postural tachycardia, orthostatic hypotension, or autonomic dysfunction).
Key Steps
The guidelines address two key steps for each PNS manifestation — the workup and evaluation of patients with suspected ANS manifestation including standard evaluations, diagnostic tests, and treatment. The experts developed 31 best practices for diagnosis and workup and 20 treatment recommendations.
Initial assessment of potential ANS involvement includes asking patients about orthostatic postural lightheadedness and difficulties with digestion, urination, sweating, and sexual function.
Treatment of autoimmune diseases typically focuses on relieving symptoms and can include steroids, the anticonvulsant gabapentin, the monoclonal antibody rituximab, and intravenous immunoglobulin. “The type of neuropathy will mandate or suggest certain therapies over others,” said Dr. Sarka, adding that a patient can have more than one neuropathy.
Therapeutics for Sjögren disease is another example of an area that has been “very haphazard,” he added.
The guidelines are aimed not just at specialists but also at general practitioners who treat many of these patients. But Dr. Hammitt emphasized that neurologists can be “instrumental” in identifying Sjögren disease in patients with PNS symptoms.
“Our hope is that specialists — in this case, neurologists — will recognize the potential for this condition in their PNS patients and ensure referral to a rheumatologist or knowledgeable family practitioner to manage overall care.”
The committee will soon submit its manuscript to the AAN for publication.
“Once published, we will have a robust dissemination strategy to ensure that providers, patients, and policymakers are aware of, and use, this very valuable resource,” said Dr. Hammitt.
No conflicts of interest were reported.
A version of this article appeared on Medscape.com.
FROM AAN 2024
Mental Health Worsens in Trans, Gender-Nonconforming Adults
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.
METHODOLOGY:
- Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
- They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
- Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).
TAKEAWAY:
- Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
- The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
- The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.
IN PRACTICE:
“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”
SOURCE:
Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.
LIMITATIONS:
Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.
DISCLOSURES:
No source of study funding was listed. The authors disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Climate Change’s Impact on Respiratory Care to Increase
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Extreme heat, wildfires, and particulate matter not from wildfires were the most studied climate issues in conjunction with increased respiratory care, based on data from more than 60 studies.
Recent local events prompted Dr. Lewy and colleagues to examine the current landscape of climate change studies and respiratory healthcare.
“Last summer, when Canadian wildfire smoke enveloped the Midwest and the East Coast, patients presented with exacerbations of asthma and COPD to our clinics,” corresponding author Alexander S. Rabin, MD, of the University of Michigan, said in an interview.
“The event was a reminder of the increasing health threats that our most vulnerable patients face from climate change,” he said. “The smoke events also got us thinking about how health systems around the world are preparing, and we wanted to better understand what is known about the impacts of climate change on healthcare delivery to patients with lung disease and look for blind spots in the research,” he explained.
In the review, published in The Journal of Climate Change and Health, the researchers identified 67 studies related to climate and respiratory care; 50 of these were published between 2020 and 2023.
The most frequently studied climate and weather topics were extreme heat (31 studies), particulate matter not from wildfires (22 studies), and wildfires (19 studies).
The most common respiratory-related outcomes were respiratory-related hospital admissions (33 studies) and respiratory-related emergency department (ED) visits (24 studies).
Few studies addressed the potential impact of climate on telehealth, facility energy distribution, and pharmaceutical supplies, the researchers wrote. Notably, only one study in the review showed an association between power outages in New York City and higher chronic obstructive pulmonary disease (COPD)-related hospital admission rates, and no primary research emerged on the effects of climate change on respiratory medicine supply or distribution, they said.
Findings from studies with demographic breakdowns included evidence of greater effects of extreme weather on elderly populations compared with younger groups, and data from the seven studies focused on children showed a particular risk for climate-related respiratory exacerbations among those younger than 5 years.
The findings of the review were limited by several factors including the targeted article selection and potential misclassification bias, as respiratory outcomes often overlapped with cardiac or other outcomes, the researchers noted.
However, the results highlighted three key areas for future research. First, more studies are needed on the impact of climate on understudied populations in areas such as Africa, South America, Asia, and the Caribbean. Second, studies are needed on the impact of climate on respiratory care beyond acute care, with attention to primary and specialty respiratory care use, supply chain impacts, and effects on long-term pulmonary care and rehabilitation. Finally, more research is needed to explore solutions to the increased demands on pulmonary care in the context of climate change, including the use of telehealth, the authors wrote.
Limitations and Research Gaps
“While we found extensive published research chronicling the acute respiratory health impacts of climate change and extreme weather, such as heat waves and wildfires, we were surprised to find few studies on health system adaptation,” Dr. Rabin told this news organization.
“Although we know that prevention and long-term disease management are critical, studies looking at primary care impacts on respiratory care, healthcare infrastructure hardening, and medication supply chain resilience were largely absent from the literature,” he said. “We were further struck by the limited amount of research originating from the most climate-affected areas such as in the Global South, where outdoor air pollution already results in over 4 million deaths per year,” he noted.
Although clinicians increasingly recognize that climate change and extreme weather threaten lung health, solutions are needed to make health systems resilient, accessible, and adaptable, especially with the likely increase in demand for respiratory care, Dr. Rabin emphasized.
More research is needed on preventive measures that could mitigate the risk for bad air quality, heat, and other extreme climate change events on vulnerable populations, said Dr. Rabin. “Every domain of healthcare delivery, from pharmaceutical procurement to hospital heating and cooling system design, must account for these environmental changes,” he said. “More collaboration is needed with researchers and clinicians in areas of the world that are underrepresented and underresourced to help share knowledge and tools to build health system resilience.”
Takeaways and Next Steps
“I was struck by how many studies used healthcare metrics as a way to measure health outcomes but not to measure resilience and efficiency of healthcare systems themselves,” Dr. Lewy said in an interview. “For example, many studies used ED visits or hospital admissions as ways to measure severity of disease associated with a climate event, but the strain that increased visits or admissions have on healthcare systems was barely mentioned,” she noted.
Looking ahead, more studies that focus specifically on infrastructure as it relates to healthcare would be valuable, said Dr. Lewy. Recent research has explored virtual care as a way to mitigate climate change-associated COPD exacerbations, but virtual care may not be reliably accessible in cases of the widespread power and network outages that often accompany storms, heat waves, and other catastrophic weather events, she noted. “More research into these types of logistical factors affecting healthcare systems would be helpful,” she added.
Dr. Rabin disclosed support for the study from the US Department of Veterans Affairs but had no other financial conflicts to disclose. Dr. Lewy had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Study Evaluates CVD, Mortality Risks In Patients With Prurigo Nodularis
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
Whites Not the Predominant Victims of ‘Deaths of Despair’ Need to Address Inequality
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
Deaths of despair — defined as midlife deaths from suicide, drug overdose, and alcoholic liver disease — among African Americans surpassed the rate in White Americans in 2022, new research showed. In addition, the study also revealed that Native Americans had more than double the rate of both their Black and White counterparts that year.
These new findings, the investigators noted, counter a nearly 10-year-old narrative that was sparked by a seminal 2015 study. It showed that from 1999 to 2013 deaths of despair predominantly affected White individuals at a rate of 72.15 per 100,000 population — twice that of Black Americans.
The investigators of the 2015 study posited that such deaths in the group were linked to declining social and economic conditions and a perceived loss of status especially in White individuals without a college degree. However, the investigators noted that data for Native Americans were not included in the 2015 study or in the many follow-up analyses the research triggered.
The study was published online in JAMA Psychiatry.
Racial Differences
The current investigators assessed trends by race and ethnicity in deaths of despair in the years following the 2015 study when an increase in racial and ethnic inequality were reported for numerous causes of death.
The cross-sectional study used publicly available records from the US Centers for Disease Control and Prevention database WONDER to calculate midlife mortality in the United States from January 1999 to December 2022 to determine deaths from suicide, drug overdose, and alcoholic liver disease for White, Black, and Native American individuals aged 45-55 years. The data were then analyzed by race and ethnicity.
Results showed that deaths of despair in Black Americans (103.81 per 100,000) surpassed that of White Americans (102.63 per 100,000) in 2022. Furthermore, the rate in Black Americans tripled from 2013 to 2022 (from 36.24 to 103.81 per 100,000), with a sharp increase in such deaths from 2015 onward.
The rate for Native American and Alaska Native populations was the highest at 241.7 per 100,000 population in 2022.
It has been posited that the increase in rates of deaths of despair among White people is associated with declining social and economic conditions and a perceived loss of status, especially among White individuals without a college degree, the authors noted.
The initial seminal study became a focus of ongoing national discourse after results showed White individuals had the highest mortality rates from these causes at 72 per 100,000 people in 2013 — twice that of Black Americans.
They examined midlife mortality from suicide, drug overdose, and alcoholic liver disease between January 1999 and December 2022. The data were then analyzed by race and ethnicity.
The rate of midlife deaths from alcoholic liver disease among American Indian or Alaska Native individuals (109 per 100,000) was six times the rate of White individuals (18 per 100,000) in 2022.
Rates of midlife suicide deaths in 2022 remained elevated among Native American or Alaska Native (28 per 100,000) and White (25 per 100,000) individuals compared with Black individuals (9 per 100,000).
Increases in deaths of despair among Black and Native Americans are associated with differential access to safety resources in the context of an increasingly toxic illicit drug supply, increased rates of polysubstance use, worsening economic precarity, and stark disparities in access to mental health and substance use treatment programs, the investigators noted.
“The findings reinforce the notion that we need to invest in services that can address these issues, and ultimately, we need much more comprehensive access to low-barrier mental health care and substance use treatment in the US,” study investigator Joseph Friedman, PhD, of the David Geffen School of Medicine at UCLA, Los Angeles, California, said in a press release.
“We need to specifically make sure those treatments, services, and programs are implemented in a way that is accessible for communities of color and will actively work to address inequality,” Dr. Friedman added.
Potential study limitations include possible misclassification of race and ethnicity, which could underestimate observed inequalities, and the ecological design that precludes measuring causality of underlying factors, the researchers noted.
The investigators reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.