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Bloating common but often ignored: Survey
, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.
The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.
“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.
Results of the survey are published online in Clinical Gastroenterology and Hepatology.
Common problem, incompletely understood
To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.
Altogether, 12,324 (14%) respondents reported bloating in the past week.
The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.
The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.
Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.
Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
Suffering in silence?
Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.
About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.
“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.
Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.
A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.
Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.
Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.
“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.
“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.
Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.
A version of this article first appeared on Medscape.com.
, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.
The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.
“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.
Results of the survey are published online in Clinical Gastroenterology and Hepatology.
Common problem, incompletely understood
To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.
Altogether, 12,324 (14%) respondents reported bloating in the past week.
The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.
The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.
Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.
Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
Suffering in silence?
Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.
About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.
“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.
Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.
A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.
Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.
Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.
“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.
“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.
Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.
A version of this article first appeared on Medscape.com.
, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.
The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.
“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.
Results of the survey are published online in Clinical Gastroenterology and Hepatology.
Common problem, incompletely understood
To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.
Altogether, 12,324 (14%) respondents reported bloating in the past week.
The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.
The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.
Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.
Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
Suffering in silence?
Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.
About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.
“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.
Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.
A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.
Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.
Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.
“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.
“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.
Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Fentanyl vaccine a potential ‘game changer’ for opioid crisis
Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.
In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.
“Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.
“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.
The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.
If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.
The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths.
Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”
“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.
Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.
A version of this article first appeared on Medscape.com.
Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.
In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.
“Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.
“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.
The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.
If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.
The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths.
Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”
“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.
Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.
A version of this article first appeared on Medscape.com.
Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.
In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.
“Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.
“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.
The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.
If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.
The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths.
Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”
“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.
Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.
A version of this article first appeared on Medscape.com.
FROM PHARMACEUTICS
Major life stressors ‘strongly predictive’ of long COVID symptoms
new research suggests.
Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.
These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.
The findings were published online in the Journal of the Neurological Sciences.
Major stressful events common
Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points.
Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.
In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8.
The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.
Long-term sequelae of COVID are increasingly recognized as major public health issues.
It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work.
Holistic approach
Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”
She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”
Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.
She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.
“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.
“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.
The study had no commercial funding. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.
These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.
The findings were published online in the Journal of the Neurological Sciences.
Major stressful events common
Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points.
Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.
In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8.
The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.
Long-term sequelae of COVID are increasingly recognized as major public health issues.
It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work.
Holistic approach
Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”
She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”
Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.
She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.
“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.
“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.
The study had no commercial funding. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Major life stressors in the year after hospital discharge for COVID-19 are “strongly predictive of a lot of the important outcomes that people may face after COVID,” lead investigator Jennifer A. Frontera, MD, a professor in the department of neurology at New York University Langone Health, said in an interview.
These outcomes include depression, brain fog, fatigue, trouble sleeping, and other long COVID symptoms.
The findings were published online in the Journal of the Neurological Sciences.
Major stressful events common
Dr. Frontera and the NYU Neurology COVID-19 study team evaluated 451 adults who survived a COVID hospital stay. Of these, 383 completed a 6-month follow-up, 242 completed a 12-month follow-up, and 174 completed follow-up at both time points.
Within 1 year of discharge, 77 (17%) patients died and 51% suffered a major stressful life event.
In multivariable analyses, major life stressors – including financial insecurity, food insecurity, death of a close contact, and new disability – were strong independent predictors of disability, trouble with activities of daily living, depression, fatigue, sleep problems, and prolonged post-acute COVID symptoms. The adjusted odds ratios for these outcomes ranged from 2.5 to 20.8.
The research also confirmed the contribution of traditional risk factors for long COVID symptoms, as shown in past studies. These include older age, poor pre-COVID functional status, and more severe initial COVID-19 infection.
Long-term sequelae of COVID are increasingly recognized as major public health issues.
It has been estimated that roughly 16 million U.S. adults aged 18-65 years ave long COVID, with the often debilitating symptoms keeping up to 4 million out of work.
Holistic approach
Dr. Frontera said it’s important to realize that “sleep, fatigue, anxiety, depression, even cognition are so interwoven with each other that anything that impacts any one of them could have repercussions on the other.”
She added that it “certainly makes sense that there is an interplay or even a bidirectional relationship between the stressors that people face and how well they can recover after COVID.”
Therapies that lessen the trauma of the most stress-inducing life events need to be a central part of treatment for long COVID, with more research needed to validate the best approaches, Dr. Frontera said.
She also noted that social services or case management resources may be able to help address at least some of the stressors that individuals are under – and it is important to refer them to these resources. Referral to mental health services is also important.
“I think it’s really important to take a holistic approach and try to deal with whatever the problem may be,” said Dr. Frontera.
“I’m a neurologist, but as part of my evaluation, I really need to address if there are life stressors or mental health issues that may be impacting this person’s function,” she added.
The study had no commercial funding. The investigators reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE NEUROLOGICAL SCIENCES
Bepirovirsen: Is a ‘functional cure’ for HBV on the horizon?
Treatment with bepirovirsen led to sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after the end of treatment for adults with chronic HBV in the phase 2b B-Clear study.
The study results were presented at the annual meeting of the American Association for the Study of Liver Diseases and were simultaneously published in The New England Journal of Medicine.
Currently, nucleoside/nucleotide analogue (NA) therapy is the recommended first-line therapy for patients with chronic HBV because it can inhibit viral replication.
However, fewer than 5% of patients have HBsAg loss after 12 months of NA therapy, which underscores the need for therapies that can achieve a “functional” cure, largely defined as sustained, undetectable levels of HBV DNA and HBsAg in the blood, with or without generation of protective antibodies against HBsAg, the researchers noted.
Bepirovirsen is a potential first-in-class antisense oligonucleotide that targets all HBV messenger RNA and acts to decrease levels of viral proteins.
The phase 2b B-Clear study enrolled 457 patients with chronic HBV; 227 were receiving NA therapy, and 230 were not.
Participants were randomly assigned to receive weekly subcutaneous injections of bepirovirsen 300 mg for 24 weeks; bepirovirsen 300 mg for 12 weeks, then 150 mg for 12 weeks; bepirovirsen 300 mg for 12 weeks, then placebo for 12 weeks; or placebo for 12 weeks, then bepirovirsen 300 mg for 12 weeks (groups 1, 2, 3, and 4, respectively).
The composite primary outcome was HBsAg level below the limit of detection and HBV DNA level below the limit of quantification maintained for 24 weeks after the end of bepirovirsen treatment, without newly initiated antiviral medication.
Bepirovirsen 300 mg weekly for 24 weeks (group 1) led to HBsAg and HBV DNA loss in 9% of patients receiving NA therapy and 10% of patients not receiving NA treatment, which was sustained for 24 weeks after the last dose.
For groups 2, 3, and 4, HBsAg and HBV DNA loss occurred in 9%, 3%, and 0%, respectively, of patients receiving NA therapy and 6%, 1%, and 0%, respectively, of patients not receiving NA treatment.
Patients with low baseline HBsAg levels (< 1,000 IU/mL) responded best to treatment with bepirovirsen. Among patients who received bepirovirsen 300 mg weekly for 24 weeks, the primary outcome was achieved by 16% of patients taking NA therapy and by 25% of patients not taking NA therapy.
Although a “relatively low percentage” of patients overall achieved the primary outcome, the study “indicates the possibility of enhanced efficacy with the selection of patients according to baseline characteristics (low HBsAg level at baseline), with combination therapies, or both,” the researchers wrote.
Adverse events with bepirovirsen included injection-site reactions, pyrexia, fatigue, and increased alanine aminotransferase (ALT) levels. Increases in ALT levels, which were more common in those not receiving NA therapy than in those receiving NA therapy (41% vs. 17%), led to two serious adverse events.
On the basis of phase 2b data, GlaxoSmithKline (GSK) plans to advance bepirovirsen into phase 3 development, according to a news release.
Further pursuit of bepirovirsen therapy is “certainly warranted, with the use of a dose of 300 mg per week for at least 24 weeks; indeed, the duration of therapy might be dictated best by HBsAg levels at baseline,” Jay H. Hoofnagle, MD, director of the liver disease research branch at the National Institute of Diabetes and Digestive and Kidney Diseases, wrote in an editorial in the New England Journal of Medicine.
Several critical questions remain, including whether HBsAg negativity will persist beyond 24 weeks, wrote Dr. Hoofnagle, who was not involved in the study.
It’s a question GSK is addressing in the B-Sure trial, which will follow participants for an additional 33 months, the study noted.
Other questions include when NA therapy can be safely stopped, what other factors predict response, and whether RNA therapy–induced loss of HBsAg materially improves long-term outcomes, Dr. Hoofnagle wrote.
“Bepirovirsen is just one RNA-based HBV therapy now being pursued. Several other antisense RNAs as well as the more malleable small interfering RNA molecules (‘-sirans’) are currently in early-phase clinical trials. A new era in the control of hepatitis B may be at hand with these most modern of therapies for this most ancient disease,” Dr. Hoofnagle noted.
The B-Clear study was supported by GSK. Several authors have disclosed relationships with the company. A complete list of author disclosures is available with the original article. Dr. Hoofnagle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Treatment with bepirovirsen led to sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after the end of treatment for adults with chronic HBV in the phase 2b B-Clear study.
The study results were presented at the annual meeting of the American Association for the Study of Liver Diseases and were simultaneously published in The New England Journal of Medicine.
Currently, nucleoside/nucleotide analogue (NA) therapy is the recommended first-line therapy for patients with chronic HBV because it can inhibit viral replication.
However, fewer than 5% of patients have HBsAg loss after 12 months of NA therapy, which underscores the need for therapies that can achieve a “functional” cure, largely defined as sustained, undetectable levels of HBV DNA and HBsAg in the blood, with or without generation of protective antibodies against HBsAg, the researchers noted.
Bepirovirsen is a potential first-in-class antisense oligonucleotide that targets all HBV messenger RNA and acts to decrease levels of viral proteins.
The phase 2b B-Clear study enrolled 457 patients with chronic HBV; 227 were receiving NA therapy, and 230 were not.
Participants were randomly assigned to receive weekly subcutaneous injections of bepirovirsen 300 mg for 24 weeks; bepirovirsen 300 mg for 12 weeks, then 150 mg for 12 weeks; bepirovirsen 300 mg for 12 weeks, then placebo for 12 weeks; or placebo for 12 weeks, then bepirovirsen 300 mg for 12 weeks (groups 1, 2, 3, and 4, respectively).
The composite primary outcome was HBsAg level below the limit of detection and HBV DNA level below the limit of quantification maintained for 24 weeks after the end of bepirovirsen treatment, without newly initiated antiviral medication.
Bepirovirsen 300 mg weekly for 24 weeks (group 1) led to HBsAg and HBV DNA loss in 9% of patients receiving NA therapy and 10% of patients not receiving NA treatment, which was sustained for 24 weeks after the last dose.
For groups 2, 3, and 4, HBsAg and HBV DNA loss occurred in 9%, 3%, and 0%, respectively, of patients receiving NA therapy and 6%, 1%, and 0%, respectively, of patients not receiving NA treatment.
Patients with low baseline HBsAg levels (< 1,000 IU/mL) responded best to treatment with bepirovirsen. Among patients who received bepirovirsen 300 mg weekly for 24 weeks, the primary outcome was achieved by 16% of patients taking NA therapy and by 25% of patients not taking NA therapy.
Although a “relatively low percentage” of patients overall achieved the primary outcome, the study “indicates the possibility of enhanced efficacy with the selection of patients according to baseline characteristics (low HBsAg level at baseline), with combination therapies, or both,” the researchers wrote.
Adverse events with bepirovirsen included injection-site reactions, pyrexia, fatigue, and increased alanine aminotransferase (ALT) levels. Increases in ALT levels, which were more common in those not receiving NA therapy than in those receiving NA therapy (41% vs. 17%), led to two serious adverse events.
On the basis of phase 2b data, GlaxoSmithKline (GSK) plans to advance bepirovirsen into phase 3 development, according to a news release.
Further pursuit of bepirovirsen therapy is “certainly warranted, with the use of a dose of 300 mg per week for at least 24 weeks; indeed, the duration of therapy might be dictated best by HBsAg levels at baseline,” Jay H. Hoofnagle, MD, director of the liver disease research branch at the National Institute of Diabetes and Digestive and Kidney Diseases, wrote in an editorial in the New England Journal of Medicine.
Several critical questions remain, including whether HBsAg negativity will persist beyond 24 weeks, wrote Dr. Hoofnagle, who was not involved in the study.
It’s a question GSK is addressing in the B-Sure trial, which will follow participants for an additional 33 months, the study noted.
Other questions include when NA therapy can be safely stopped, what other factors predict response, and whether RNA therapy–induced loss of HBsAg materially improves long-term outcomes, Dr. Hoofnagle wrote.
“Bepirovirsen is just one RNA-based HBV therapy now being pursued. Several other antisense RNAs as well as the more malleable small interfering RNA molecules (‘-sirans’) are currently in early-phase clinical trials. A new era in the control of hepatitis B may be at hand with these most modern of therapies for this most ancient disease,” Dr. Hoofnagle noted.
The B-Clear study was supported by GSK. Several authors have disclosed relationships with the company. A complete list of author disclosures is available with the original article. Dr. Hoofnagle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Treatment with bepirovirsen led to sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after the end of treatment for adults with chronic HBV in the phase 2b B-Clear study.
The study results were presented at the annual meeting of the American Association for the Study of Liver Diseases and were simultaneously published in The New England Journal of Medicine.
Currently, nucleoside/nucleotide analogue (NA) therapy is the recommended first-line therapy for patients with chronic HBV because it can inhibit viral replication.
However, fewer than 5% of patients have HBsAg loss after 12 months of NA therapy, which underscores the need for therapies that can achieve a “functional” cure, largely defined as sustained, undetectable levels of HBV DNA and HBsAg in the blood, with or without generation of protective antibodies against HBsAg, the researchers noted.
Bepirovirsen is a potential first-in-class antisense oligonucleotide that targets all HBV messenger RNA and acts to decrease levels of viral proteins.
The phase 2b B-Clear study enrolled 457 patients with chronic HBV; 227 were receiving NA therapy, and 230 were not.
Participants were randomly assigned to receive weekly subcutaneous injections of bepirovirsen 300 mg for 24 weeks; bepirovirsen 300 mg for 12 weeks, then 150 mg for 12 weeks; bepirovirsen 300 mg for 12 weeks, then placebo for 12 weeks; or placebo for 12 weeks, then bepirovirsen 300 mg for 12 weeks (groups 1, 2, 3, and 4, respectively).
The composite primary outcome was HBsAg level below the limit of detection and HBV DNA level below the limit of quantification maintained for 24 weeks after the end of bepirovirsen treatment, without newly initiated antiviral medication.
Bepirovirsen 300 mg weekly for 24 weeks (group 1) led to HBsAg and HBV DNA loss in 9% of patients receiving NA therapy and 10% of patients not receiving NA treatment, which was sustained for 24 weeks after the last dose.
For groups 2, 3, and 4, HBsAg and HBV DNA loss occurred in 9%, 3%, and 0%, respectively, of patients receiving NA therapy and 6%, 1%, and 0%, respectively, of patients not receiving NA treatment.
Patients with low baseline HBsAg levels (< 1,000 IU/mL) responded best to treatment with bepirovirsen. Among patients who received bepirovirsen 300 mg weekly for 24 weeks, the primary outcome was achieved by 16% of patients taking NA therapy and by 25% of patients not taking NA therapy.
Although a “relatively low percentage” of patients overall achieved the primary outcome, the study “indicates the possibility of enhanced efficacy with the selection of patients according to baseline characteristics (low HBsAg level at baseline), with combination therapies, or both,” the researchers wrote.
Adverse events with bepirovirsen included injection-site reactions, pyrexia, fatigue, and increased alanine aminotransferase (ALT) levels. Increases in ALT levels, which were more common in those not receiving NA therapy than in those receiving NA therapy (41% vs. 17%), led to two serious adverse events.
On the basis of phase 2b data, GlaxoSmithKline (GSK) plans to advance bepirovirsen into phase 3 development, according to a news release.
Further pursuit of bepirovirsen therapy is “certainly warranted, with the use of a dose of 300 mg per week for at least 24 weeks; indeed, the duration of therapy might be dictated best by HBsAg levels at baseline,” Jay H. Hoofnagle, MD, director of the liver disease research branch at the National Institute of Diabetes and Digestive and Kidney Diseases, wrote in an editorial in the New England Journal of Medicine.
Several critical questions remain, including whether HBsAg negativity will persist beyond 24 weeks, wrote Dr. Hoofnagle, who was not involved in the study.
It’s a question GSK is addressing in the B-Sure trial, which will follow participants for an additional 33 months, the study noted.
Other questions include when NA therapy can be safely stopped, what other factors predict response, and whether RNA therapy–induced loss of HBsAg materially improves long-term outcomes, Dr. Hoofnagle wrote.
“Bepirovirsen is just one RNA-based HBV therapy now being pursued. Several other antisense RNAs as well as the more malleable small interfering RNA molecules (‘-sirans’) are currently in early-phase clinical trials. A new era in the control of hepatitis B may be at hand with these most modern of therapies for this most ancient disease,” Dr. Hoofnagle noted.
The B-Clear study was supported by GSK. Several authors have disclosed relationships with the company. A complete list of author disclosures is available with the original article. Dr. Hoofnagle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LIVER MEETING
Vonoprazan promising for erosive esophagitis
, according to results of the phase 3 PHALCON-EE trial.
Vonoprazan achieved higher rates of healing and maintenance of healing than lansoprazole, with the benefit seen primarily in patients with more severe esophagitis.
The differences in healing rates were evident after 2 weeks of therapy and were maintained throughout the 24-week study, report Loren Laine, MD, Yale University, New Haven, Conn., and colleagues.
The study was published online in Gastroenterology.
More potent acid suppression
Gastroesophageal reflux disease is one of the most common disorders of the gastrointestinal tract, and erosive esophagitis is its most common complication.
Although standard PPI therapy is effective for healing erosive esophagitis, some patients do not achieve success with this conventional treatment.
Studies suggest that lack of healing of erosive esophagitis with 8 weeks of PPI therapy can be expected in roughly 5%-20% of patients, with rates up to 30% reported in patients with more severe esophagitis.
The PCAB vonoprazan provides more potent inhibition of gastric acid than PPIs and is seen as a potential alternative. However, data on its efficacy for erosive esophagitis are limited, the authors note.
The PHALCON-EE trial enrolled 1,024 adults from the United States and Europe with erosive esophagitis without Helicobacter pylori infection or Barrett esophagus.
Participants were randomized to receive once-daily vonoprazan 20 mg or lansoprazole 30 mg for up to 8 weeks in the healing phase.
The 878 patients with healing were then rerandomized to receive once-daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks in the maintenance phase.
For healing by week 8, vonoprazan was noninferior to lansoprazole in the primary analysis and superior to lansoprazole in a predefined exploratory analysis (92.9% vs. 84.6%; P < .0001).
Secondary analyses showed that vonoprazan was noninferior to lansoprazole in mean 24-hour heartburn-free days and superior in healing at week 2 for grade C/D esophagitis (70.2% vs. 52.6%; P = .0008).
For maintenance of healing at week 24, vonoprazan was noninferior to lansoprazole in the primary analysis and superior on secondary analysis of healing (80.7% for vonoprazan 20 mg and 79.2% for vonoprazan 10 mg vs. 72.0% for lansoprazole; P < .0001 for both comparisons).
The most common adverse event reported in the healing phase was diarrhea and in the maintenance phase was COVID-19. Two deaths occurred, both from COVID-19, during the maintenance phase in the vonoprazan 20-mg group.
As expected, serum gastrin increased to a greater extent with vonoprazan than lansoprazole, with levels > 500 pg/mL in 16% of those taking 20 mg at the end of maintenance therapy, the authors report. After stopping vonoprazan, gastrin levels dropped by roughly 60%-65% within 4 weeks.
Promising new option
“PCABs are a promising new option,” Avin Aggarwal, MD, who was not involved in the study, told this news organization.
They have a “more potent acid inhibitory effect” and have shown “superior healing of erosive esophagitis,” said Dr. Aggarwal, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona in Tucson.
The results of the PHALCON-EE trial “validate noninferiority of PCABs compared to standard PPI therapy in the Western population after being proven in multiple Asian studies,” he said.
Dr. Aggarwal noted that PCABs work the same way as PPIs, by blocking the proton pumps, but “the longer half-life of PCABs and action on both active and inactive proton channels result in greater acid inhibition.”
Long-term effects of PCAB therapy from stronger acid inhibition and resulting hypergastrinemia still remain to be determined, he said.
Earlier this year, the U.S. Food and Drug Administration accepted Phathom Pharmaceuticals’ new drug application for vonoprazan for the treatment of erosive esophagitis.
Last May, the FDA approved two vonoprazan-based therapies for the treatment of H. pylori infection.
The study was funded by Phathom Pharmaceuticals. Dr. Laine and several coauthors have disclosed financial relationships with the company. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to results of the phase 3 PHALCON-EE trial.
Vonoprazan achieved higher rates of healing and maintenance of healing than lansoprazole, with the benefit seen primarily in patients with more severe esophagitis.
The differences in healing rates were evident after 2 weeks of therapy and were maintained throughout the 24-week study, report Loren Laine, MD, Yale University, New Haven, Conn., and colleagues.
The study was published online in Gastroenterology.
More potent acid suppression
Gastroesophageal reflux disease is one of the most common disorders of the gastrointestinal tract, and erosive esophagitis is its most common complication.
Although standard PPI therapy is effective for healing erosive esophagitis, some patients do not achieve success with this conventional treatment.
Studies suggest that lack of healing of erosive esophagitis with 8 weeks of PPI therapy can be expected in roughly 5%-20% of patients, with rates up to 30% reported in patients with more severe esophagitis.
The PCAB vonoprazan provides more potent inhibition of gastric acid than PPIs and is seen as a potential alternative. However, data on its efficacy for erosive esophagitis are limited, the authors note.
The PHALCON-EE trial enrolled 1,024 adults from the United States and Europe with erosive esophagitis without Helicobacter pylori infection or Barrett esophagus.
Participants were randomized to receive once-daily vonoprazan 20 mg or lansoprazole 30 mg for up to 8 weeks in the healing phase.
The 878 patients with healing were then rerandomized to receive once-daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks in the maintenance phase.
For healing by week 8, vonoprazan was noninferior to lansoprazole in the primary analysis and superior to lansoprazole in a predefined exploratory analysis (92.9% vs. 84.6%; P < .0001).
Secondary analyses showed that vonoprazan was noninferior to lansoprazole in mean 24-hour heartburn-free days and superior in healing at week 2 for grade C/D esophagitis (70.2% vs. 52.6%; P = .0008).
For maintenance of healing at week 24, vonoprazan was noninferior to lansoprazole in the primary analysis and superior on secondary analysis of healing (80.7% for vonoprazan 20 mg and 79.2% for vonoprazan 10 mg vs. 72.0% for lansoprazole; P < .0001 for both comparisons).
The most common adverse event reported in the healing phase was diarrhea and in the maintenance phase was COVID-19. Two deaths occurred, both from COVID-19, during the maintenance phase in the vonoprazan 20-mg group.
As expected, serum gastrin increased to a greater extent with vonoprazan than lansoprazole, with levels > 500 pg/mL in 16% of those taking 20 mg at the end of maintenance therapy, the authors report. After stopping vonoprazan, gastrin levels dropped by roughly 60%-65% within 4 weeks.
Promising new option
“PCABs are a promising new option,” Avin Aggarwal, MD, who was not involved in the study, told this news organization.
They have a “more potent acid inhibitory effect” and have shown “superior healing of erosive esophagitis,” said Dr. Aggarwal, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona in Tucson.
The results of the PHALCON-EE trial “validate noninferiority of PCABs compared to standard PPI therapy in the Western population after being proven in multiple Asian studies,” he said.
Dr. Aggarwal noted that PCABs work the same way as PPIs, by blocking the proton pumps, but “the longer half-life of PCABs and action on both active and inactive proton channels result in greater acid inhibition.”
Long-term effects of PCAB therapy from stronger acid inhibition and resulting hypergastrinemia still remain to be determined, he said.
Earlier this year, the U.S. Food and Drug Administration accepted Phathom Pharmaceuticals’ new drug application for vonoprazan for the treatment of erosive esophagitis.
Last May, the FDA approved two vonoprazan-based therapies for the treatment of H. pylori infection.
The study was funded by Phathom Pharmaceuticals. Dr. Laine and several coauthors have disclosed financial relationships with the company. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to results of the phase 3 PHALCON-EE trial.
Vonoprazan achieved higher rates of healing and maintenance of healing than lansoprazole, with the benefit seen primarily in patients with more severe esophagitis.
The differences in healing rates were evident after 2 weeks of therapy and were maintained throughout the 24-week study, report Loren Laine, MD, Yale University, New Haven, Conn., and colleagues.
The study was published online in Gastroenterology.
More potent acid suppression
Gastroesophageal reflux disease is one of the most common disorders of the gastrointestinal tract, and erosive esophagitis is its most common complication.
Although standard PPI therapy is effective for healing erosive esophagitis, some patients do not achieve success with this conventional treatment.
Studies suggest that lack of healing of erosive esophagitis with 8 weeks of PPI therapy can be expected in roughly 5%-20% of patients, with rates up to 30% reported in patients with more severe esophagitis.
The PCAB vonoprazan provides more potent inhibition of gastric acid than PPIs and is seen as a potential alternative. However, data on its efficacy for erosive esophagitis are limited, the authors note.
The PHALCON-EE trial enrolled 1,024 adults from the United States and Europe with erosive esophagitis without Helicobacter pylori infection or Barrett esophagus.
Participants were randomized to receive once-daily vonoprazan 20 mg or lansoprazole 30 mg for up to 8 weeks in the healing phase.
The 878 patients with healing were then rerandomized to receive once-daily vonoprazan 10 mg, vonoprazan 20 mg, or lansoprazole 15 mg for 24 weeks in the maintenance phase.
For healing by week 8, vonoprazan was noninferior to lansoprazole in the primary analysis and superior to lansoprazole in a predefined exploratory analysis (92.9% vs. 84.6%; P < .0001).
Secondary analyses showed that vonoprazan was noninferior to lansoprazole in mean 24-hour heartburn-free days and superior in healing at week 2 for grade C/D esophagitis (70.2% vs. 52.6%; P = .0008).
For maintenance of healing at week 24, vonoprazan was noninferior to lansoprazole in the primary analysis and superior on secondary analysis of healing (80.7% for vonoprazan 20 mg and 79.2% for vonoprazan 10 mg vs. 72.0% for lansoprazole; P < .0001 for both comparisons).
The most common adverse event reported in the healing phase was diarrhea and in the maintenance phase was COVID-19. Two deaths occurred, both from COVID-19, during the maintenance phase in the vonoprazan 20-mg group.
As expected, serum gastrin increased to a greater extent with vonoprazan than lansoprazole, with levels > 500 pg/mL in 16% of those taking 20 mg at the end of maintenance therapy, the authors report. After stopping vonoprazan, gastrin levels dropped by roughly 60%-65% within 4 weeks.
Promising new option
“PCABs are a promising new option,” Avin Aggarwal, MD, who was not involved in the study, told this news organization.
They have a “more potent acid inhibitory effect” and have shown “superior healing of erosive esophagitis,” said Dr. Aggarwal, a gastroenterologist and medical director of Banner Health’s South Campus endoscopy services and clinical assistant professor at the University of Arizona in Tucson.
The results of the PHALCON-EE trial “validate noninferiority of PCABs compared to standard PPI therapy in the Western population after being proven in multiple Asian studies,” he said.
Dr. Aggarwal noted that PCABs work the same way as PPIs, by blocking the proton pumps, but “the longer half-life of PCABs and action on both active and inactive proton channels result in greater acid inhibition.”
Long-term effects of PCAB therapy from stronger acid inhibition and resulting hypergastrinemia still remain to be determined, he said.
Earlier this year, the U.S. Food and Drug Administration accepted Phathom Pharmaceuticals’ new drug application for vonoprazan for the treatment of erosive esophagitis.
Last May, the FDA approved two vonoprazan-based therapies for the treatment of H. pylori infection.
The study was funded by Phathom Pharmaceuticals. Dr. Laine and several coauthors have disclosed financial relationships with the company. Dr. Aggarwal reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
Electrolyte disturbances a harbinger of eating disorders?
Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.
Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.
“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.
“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.
The study was published online in JAMA Network Open.
Tailored screening?
Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.
To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.
They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).
An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).
The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).
Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.
Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.
The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.
The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.
Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.
Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.
They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
Underdiagnosed, undertreated
Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”
“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.
“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.
“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.
This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.
Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.
“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.
“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.
The study was published online in JAMA Network Open.
Tailored screening?
Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.
To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.
They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).
An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).
The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).
Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.
Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.
The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.
The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.
Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.
Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.
They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
Underdiagnosed, undertreated
Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”
“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.
“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.
“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.
This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.
Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.
“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.
“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.
The study was published online in JAMA Network Open.
Tailored screening?
Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.
To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.
They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).
An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).
The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).
Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.
Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.
The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.
The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.
Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.
Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.
They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
Underdiagnosed, undertreated
Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”
“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.
“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.
“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.
This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Hiccups in patients with cancer often overlooked, undertreated
But even if recognized, hiccups may not be treated effectively, according to a national survey of cancer care clinicians.
When poorly controlled, persistent hiccups can affect a patient’s quality of life, with 40% of survey respondents considering chronic hiccups “much more” or “somewhat more” severe than nausea and vomiting.
Overall, the findings indicate that patients with cancer who develop persistent hiccups are “truly suffering,” the authors wrote.
The survey results were published online recently in the American Journal of Hospice and Palliative Medicine.
Hiccups may simply be a nuisance for most, but these spasms can become problematic for patients with cancer, leading to sleep deprivation, fatigue, aspiration pneumonia, compromised food intake, weight loss, pain, and even death.
Hiccups can develop when the nerve that controls the diaphragm becomes irritated, which can be triggered by certain chemotherapy drugs.
Yet few studies have focused on hiccups in patients with cancer and none, until now, has sought the perspectives of cancer care clinicians.
Aminah Jatoi, MD, medical oncologist with the Mayo Clinic in Rochester, Minn., and two Mayo colleagues developed a survey, alongside MeterHealth, which this news organization distributed to clinicians with an interest in cancer care.
The survey gauged clinicians’ awareness or lack of awareness about clinically significant hiccups as well as treatments for hiccups and whether they consider hiccups an unmet palliative need.
A total of 684 clinicians completed two eligibility screening questions, which required them to have cared for more than 10 patients with cancer in the past 6 months with clinically significant hiccups (defined as hiccups that lasted more than 48 hours or occurred from cancer or cancer care).
Among 113 eligible health care professionals, 90 completed the survey: 42 physicians, 29 nurses, 15 nurse practitioners, and 4 physician assistants.
The survey revealed three key issues.
The first is that hiccups appear to be an underrecognized issue.
Among health care professionals who answered the eligibility screening questions, fewer than 20% reported caring for more than 10 patients with cancer in the past 6 months who had persistent hiccups. Most of these clinicians reported caring for more than 1,000 patients per year.
Given that 15%-40% of patients with cancer report hiccups, this finding suggests that hiccups are not widely recognized by health care professionals.
Second: The survey data showed that hiccups often increase patients’ anxiety, fatigue, and sleep problems and can decrease productivity at work or school.
In fact, when comparing hiccups to nausea and vomiting – sometimes described as one of the most severe side effects of cancer care – 40% of respondents rated hiccups as “much more” or “somewhat more” severe than nausea and vomiting for their patients and 38% rated the severity of the two issues as “about the same.”
Finally, even when hiccups are recognized and treated, about 20% of respondents said that current therapies are not very effective, and more treatment options are needed.
Among the survey respondents, the most frequently prescribed medications for chronic hiccups were the antipsychotic chlorpromazine, the muscle relaxant baclofen (Lioresal), the antiemetic metoclopramide (Metozolv ODT, Reglan), and the anticonvulsants gabapentin (Neurontin) and carbamazepine (Tegretol).
Survey respondents who provided comments about current treatments for hiccups highlighted a range of challenges. One respondent said, “When current therapies do not work, it can be very demoralizing to our patients.” Another said, “I feel like it is a gamble whether treatment for hiccups will work or not.”
Still another felt that while current treatments work “quite well to halt hiccups,” they come with side effects which can be “quite severe.”
These results “clearly point to the unmet needs of hiccups in patients with cancer and should prompt more research aimed at generating more palliative options,” the authors said.
This research had no commercial funding. MeterHealth reviewed the manuscript and provided input on the accuracy of methods and results. Dr. Jatoi reports serving on an advisory board for MeterHealth (honoraria to institution).
A version of this article first appeared on Medscape.com.
But even if recognized, hiccups may not be treated effectively, according to a national survey of cancer care clinicians.
When poorly controlled, persistent hiccups can affect a patient’s quality of life, with 40% of survey respondents considering chronic hiccups “much more” or “somewhat more” severe than nausea and vomiting.
Overall, the findings indicate that patients with cancer who develop persistent hiccups are “truly suffering,” the authors wrote.
The survey results were published online recently in the American Journal of Hospice and Palliative Medicine.
Hiccups may simply be a nuisance for most, but these spasms can become problematic for patients with cancer, leading to sleep deprivation, fatigue, aspiration pneumonia, compromised food intake, weight loss, pain, and even death.
Hiccups can develop when the nerve that controls the diaphragm becomes irritated, which can be triggered by certain chemotherapy drugs.
Yet few studies have focused on hiccups in patients with cancer and none, until now, has sought the perspectives of cancer care clinicians.
Aminah Jatoi, MD, medical oncologist with the Mayo Clinic in Rochester, Minn., and two Mayo colleagues developed a survey, alongside MeterHealth, which this news organization distributed to clinicians with an interest in cancer care.
The survey gauged clinicians’ awareness or lack of awareness about clinically significant hiccups as well as treatments for hiccups and whether they consider hiccups an unmet palliative need.
A total of 684 clinicians completed two eligibility screening questions, which required them to have cared for more than 10 patients with cancer in the past 6 months with clinically significant hiccups (defined as hiccups that lasted more than 48 hours or occurred from cancer or cancer care).
Among 113 eligible health care professionals, 90 completed the survey: 42 physicians, 29 nurses, 15 nurse practitioners, and 4 physician assistants.
The survey revealed three key issues.
The first is that hiccups appear to be an underrecognized issue.
Among health care professionals who answered the eligibility screening questions, fewer than 20% reported caring for more than 10 patients with cancer in the past 6 months who had persistent hiccups. Most of these clinicians reported caring for more than 1,000 patients per year.
Given that 15%-40% of patients with cancer report hiccups, this finding suggests that hiccups are not widely recognized by health care professionals.
Second: The survey data showed that hiccups often increase patients’ anxiety, fatigue, and sleep problems and can decrease productivity at work or school.
In fact, when comparing hiccups to nausea and vomiting – sometimes described as one of the most severe side effects of cancer care – 40% of respondents rated hiccups as “much more” or “somewhat more” severe than nausea and vomiting for their patients and 38% rated the severity of the two issues as “about the same.”
Finally, even when hiccups are recognized and treated, about 20% of respondents said that current therapies are not very effective, and more treatment options are needed.
Among the survey respondents, the most frequently prescribed medications for chronic hiccups were the antipsychotic chlorpromazine, the muscle relaxant baclofen (Lioresal), the antiemetic metoclopramide (Metozolv ODT, Reglan), and the anticonvulsants gabapentin (Neurontin) and carbamazepine (Tegretol).
Survey respondents who provided comments about current treatments for hiccups highlighted a range of challenges. One respondent said, “When current therapies do not work, it can be very demoralizing to our patients.” Another said, “I feel like it is a gamble whether treatment for hiccups will work or not.”
Still another felt that while current treatments work “quite well to halt hiccups,” they come with side effects which can be “quite severe.”
These results “clearly point to the unmet needs of hiccups in patients with cancer and should prompt more research aimed at generating more palliative options,” the authors said.
This research had no commercial funding. MeterHealth reviewed the manuscript and provided input on the accuracy of methods and results. Dr. Jatoi reports serving on an advisory board for MeterHealth (honoraria to institution).
A version of this article first appeared on Medscape.com.
But even if recognized, hiccups may not be treated effectively, according to a national survey of cancer care clinicians.
When poorly controlled, persistent hiccups can affect a patient’s quality of life, with 40% of survey respondents considering chronic hiccups “much more” or “somewhat more” severe than nausea and vomiting.
Overall, the findings indicate that patients with cancer who develop persistent hiccups are “truly suffering,” the authors wrote.
The survey results were published online recently in the American Journal of Hospice and Palliative Medicine.
Hiccups may simply be a nuisance for most, but these spasms can become problematic for patients with cancer, leading to sleep deprivation, fatigue, aspiration pneumonia, compromised food intake, weight loss, pain, and even death.
Hiccups can develop when the nerve that controls the diaphragm becomes irritated, which can be triggered by certain chemotherapy drugs.
Yet few studies have focused on hiccups in patients with cancer and none, until now, has sought the perspectives of cancer care clinicians.
Aminah Jatoi, MD, medical oncologist with the Mayo Clinic in Rochester, Minn., and two Mayo colleagues developed a survey, alongside MeterHealth, which this news organization distributed to clinicians with an interest in cancer care.
The survey gauged clinicians’ awareness or lack of awareness about clinically significant hiccups as well as treatments for hiccups and whether they consider hiccups an unmet palliative need.
A total of 684 clinicians completed two eligibility screening questions, which required them to have cared for more than 10 patients with cancer in the past 6 months with clinically significant hiccups (defined as hiccups that lasted more than 48 hours or occurred from cancer or cancer care).
Among 113 eligible health care professionals, 90 completed the survey: 42 physicians, 29 nurses, 15 nurse practitioners, and 4 physician assistants.
The survey revealed three key issues.
The first is that hiccups appear to be an underrecognized issue.
Among health care professionals who answered the eligibility screening questions, fewer than 20% reported caring for more than 10 patients with cancer in the past 6 months who had persistent hiccups. Most of these clinicians reported caring for more than 1,000 patients per year.
Given that 15%-40% of patients with cancer report hiccups, this finding suggests that hiccups are not widely recognized by health care professionals.
Second: The survey data showed that hiccups often increase patients’ anxiety, fatigue, and sleep problems and can decrease productivity at work or school.
In fact, when comparing hiccups to nausea and vomiting – sometimes described as one of the most severe side effects of cancer care – 40% of respondents rated hiccups as “much more” or “somewhat more” severe than nausea and vomiting for their patients and 38% rated the severity of the two issues as “about the same.”
Finally, even when hiccups are recognized and treated, about 20% of respondents said that current therapies are not very effective, and more treatment options are needed.
Among the survey respondents, the most frequently prescribed medications for chronic hiccups were the antipsychotic chlorpromazine, the muscle relaxant baclofen (Lioresal), the antiemetic metoclopramide (Metozolv ODT, Reglan), and the anticonvulsants gabapentin (Neurontin) and carbamazepine (Tegretol).
Survey respondents who provided comments about current treatments for hiccups highlighted a range of challenges. One respondent said, “When current therapies do not work, it can be very demoralizing to our patients.” Another said, “I feel like it is a gamble whether treatment for hiccups will work or not.”
Still another felt that while current treatments work “quite well to halt hiccups,” they come with side effects which can be “quite severe.”
These results “clearly point to the unmet needs of hiccups in patients with cancer and should prompt more research aimed at generating more palliative options,” the authors said.
This research had no commercial funding. MeterHealth reviewed the manuscript and provided input on the accuracy of methods and results. Dr. Jatoi reports serving on an advisory board for MeterHealth (honoraria to institution).
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF HOSPICE AND PALLIATIVE MEDICINE
Even mild MS relapses may signal faster disability accumulation
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
FROM ECTRIMS 2022
Longer withdrawal time reduces miss rates in screening colonoscopy
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Downward trend in Medicare payments for GI services
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY