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Prednisolone May Improve MOH Withdrawal
, an observational study out of South Korea has found.
The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034) 
The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
Study methods
The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.
The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.
Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.
Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.
The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.
Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
Commentary
Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.
Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.
“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”
He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.
Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.
, an observational study out of South Korea has found.
The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)
The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
Study methods
The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.
The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.
Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.
Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.
The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.
Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
Commentary
Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.
Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.
“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”
He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.
Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.
, an observational study out of South Korea has found.
The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)
The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
Study methods
The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.
The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.
Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.
Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.
The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.
Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
Commentary
Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.
Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.
“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”
He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.
Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.
FROM HEADACHE
Number of State Psychiatric Hospital Beds Hits Historic Low
to help establish competency for trial.
“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.
Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.
To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.
Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.
The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.
The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.
About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.
“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”
There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.
Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.
Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.
“States must strive for prevention over punishment,” the report concluded.
There was no study funding reported, nor were disclosures available.
A version of this article appeared on Medscape.com.
to help establish competency for trial.
“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.
Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.
To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.
Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.
The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.
The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.
About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.
“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”
There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.
Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.
Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.
“States must strive for prevention over punishment,” the report concluded.
There was no study funding reported, nor were disclosures available.
A version of this article appeared on Medscape.com.
to help establish competency for trial.
“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.
Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.
To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.
Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.
The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.
The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.
About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.
“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”
There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.
Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.
Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.
“States must strive for prevention over punishment,” the report concluded.
There was no study funding reported, nor were disclosures available.
A version of this article appeared on Medscape.com.
CDC Study Links Camp Lejeune Contaminated Water to Range of Cancers
For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.
In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.
Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.
The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.
Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.
For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.
In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.
Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.
The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.
Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.
For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.
In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.
Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.
The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.
Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.
Does Eliminating Alcohol Intake Lower Cancer Risk?
Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.
More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.
The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.
Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.
Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.
“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.
For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.
For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”
The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.
For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk.
“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”
The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms.
Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers.
For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.
Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.
The Case for Limiting Alcohol
While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk.
A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.
Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day.
In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.
“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said.
A version of this article appeared on Medscape.com.
Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.
More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.
The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.
Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.
Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.
“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.
For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.
For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”
The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.
For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk.
“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”
The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms.
Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers.
For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.
Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.
The Case for Limiting Alcohol
While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk.
A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.
Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day.
In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.
“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said.
A version of this article appeared on Medscape.com.
Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.
More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.
The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.
Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.
Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.
“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.
For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.
For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”
The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.
For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk.
“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”
The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms.
Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers.
For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.
Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.
The Case for Limiting Alcohol
While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk.
A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.
Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day.
In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.
“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said.
A version of this article appeared on Medscape.com.
Two-Step Screening Uncovers Heart Failure Risk in Diabetes
TOPLINE:
A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.
METHODOLOGY:
- Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
- They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
- Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
- —Clinical risk score (WATCH-DM risk score)
- —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
- —Echocardiography
- They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
- The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.
TAKEAWAY:
- Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
- Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
- The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
- Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.
IN PRACTICE:
“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.
SOURCE:
The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.
LIMITATIONS:
The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.
DISCLOSURES:
Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.
METHODOLOGY:
- Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
- They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
- Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
- —Clinical risk score (WATCH-DM risk score)
- —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
- —Echocardiography
- They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
- The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.
TAKEAWAY:
- Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
- Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
- The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
- Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.
IN PRACTICE:
“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.
SOURCE:
The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.
LIMITATIONS:
The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.
DISCLOSURES:
Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.
A version of this article appeared on Medscape.com.
TOPLINE:
A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.
METHODOLOGY:
- Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
- They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
- Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
- —Clinical risk score (WATCH-DM risk score)
- —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
- —Echocardiography
- They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
- The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.
TAKEAWAY:
- Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
- Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
- The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
- Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.
IN PRACTICE:
“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.
SOURCE:
The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.
LIMITATIONS:
The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.
DISCLOSURES:
Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.
A version of this article appeared on Medscape.com.
Biogen’s Abandonment of Controversial Alzheimer’s Drug Is No Surprise, Experts Say
“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”
Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug.
“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted.
“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said.
“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said.
After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug.
It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision.
Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease.
Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.
“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.”
Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.
Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”
A version of this article appeared on Medscape.com.
“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”
Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug.
“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted.
“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said.
“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said.
After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug.
It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision.
Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease.
Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.
“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.”
Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.
Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”
A version of this article appeared on Medscape.com.
“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”
Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug.
“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted.
“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said.
“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said.
After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug.
It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision.
Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease.
Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.
“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.”
Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.
Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”
A version of this article appeared on Medscape.com.
Utility of NSAID Response Called Into Question for Longstanding AxSpA
TOPLINE:
Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.
METHODOLOGY:
The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.
The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.
Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.
TAKEAWAY:
The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.
No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.
IN PRACTICE:
“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.
SOURCE:
The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.
LIMITATIONS:
The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”
DISCLOSURES:
The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.
METHODOLOGY:
The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.
The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.
Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.
TAKEAWAY:
The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.
No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.
IN PRACTICE:
“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.
SOURCE:
The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.
LIMITATIONS:
The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”
DISCLOSURES:
The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.
METHODOLOGY:
The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.
The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.
Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.
TAKEAWAY:
The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.
No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.
IN PRACTICE:
“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.
SOURCE:
The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.
LIMITATIONS:
The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”
DISCLOSURES:
The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Physician Fined $25K Over Supervision of DNP Who Called Herself ‘Doctor’
The case highlights the liability concerns doctors face when they oversee NPs.
According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.
Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.
A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.
For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.
Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.
Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.
However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.
Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.
Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.
Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.
“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.
“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
A version of this article appeared on Medscape.com .
The case highlights the liability concerns doctors face when they oversee NPs.
According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.
Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.
A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.
For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.
Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.
Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.
However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.
Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.
Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.
Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.
“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.
“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
A version of this article appeared on Medscape.com .
The case highlights the liability concerns doctors face when they oversee NPs.
According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.
Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.
A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.
For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.
Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.
Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.
However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.
Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.
Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.
Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.
“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.
“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
A version of this article appeared on Medscape.com .
Proinflammatory Diet May Prompt Worse Pain Course in Knee OA
TOPLINE:
Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.
METHODOLOGY:
- The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
- Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
- Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).
TAKEAWAY:
- Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
- E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
- Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.
IN PRACTICE:
“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote.
SOURCE:
The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments.
DISCLOSURES:
The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.
METHODOLOGY:
- The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
- Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
- Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).
TAKEAWAY:
- Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
- E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
- Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.
IN PRACTICE:
“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote.
SOURCE:
The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments.
DISCLOSURES:
The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Higher scores on the dietary inflammatory index in patients with knee osteoarthritis (KOA) were associated with an increased risk of experiencing greater pain over 10 years of follow-up.
METHODOLOGY:
- The researchers recruited 944 adults aged 50-80 years from the community; the mean age at baseline was 62.9 years, 51% were female, the mean body mass index was 27.9 kg/m2, and 60% had radiographic KOA at baseline.
- Magnetic resonance imaging was used to identify structural changes in the knee based on cartilage volume and bone marrow lesions at baseline and follow-up; knee pain was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain questionnaire.
- Dietary inflammation was measured using energy-adjusted dietary inflammatory index (E-DII) scores based on nutritional information from the Food-Frequency Questionnaire (FFQ).
TAKEAWAY:
- Over a follow-up period of 10.7 years, higher E-DII scores were positively associated with increased pain scores (beta = 0.21) after adjustment for age, sex, body mass index, steps per day, education, emotional problems, employment status, comorbidities, and radiographic KOA.
- E-DII scores were not associated with tibial cartilage volume loss or overall bone marrow loss.
- Patients with higher E-DII scores had a significantly higher risk of being on a moderate pain trajectory (relative risk ratio, 1.19), compared with those who followed a minimal pain trajectory over the follow-up period.
IN PRACTICE:
“An anti-inflammatory diet may reduce pain among KOA patients. Future trials investigating the potential of an anti-inflammatory diet for pain relief in KOA are warranted,” the researchers wrote.
SOURCE:
The lead author on the study was Canchen Ma, PhD, of the University of Tasmania, Hobart, Australia. The study was published online in Arthritis Care & Research.
LIMITATIONS:
The study used a relatively small number of nutrients from the FFQ to calculate the E-DII scores; participants also exhibited a narrower range of E-DII scores than previous studies. The researchers were unable to account for pharmacologic or preventive treatments.
DISCLOSURES:
The study was supported by the National Health and Medical Research Council of Australia (NHMRC) and Arthritis Australia. Several authors received support from the National Heart Foundation Fellowship, the NHMRC Leadership Fellowship, the NHMRC Practitioner Fellowship, and the NHMRC Early Career Fellowship. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Gabapentinoids Increase Exacerbation in COPD
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.
TOPLINE:
Gabapentinoid use significantly increased the risk for exacerbations in adults with chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- Previous research has prompted warnings from North American and European health agencies of severe exacerbations associated with gabapentinoid use by patients with COPD.
- The researchers compared data from patients with COPD in Canadian databases between 1994 and 2015 who were new to gabapentinoids and matched them to patients who did not use gabapentinoids.
- The primary outcome was exacerbation of COPD that required hospitalization in a propensity score-matched study.
TAKEAWAY:
- The study population included 356 epilepsy patients, 9411 neuropathic pain patients, and 3737 patients with other chronic pain.
- Use of gabapentinoids was significantly associated with an overall increased risk for severe COPD exacerbation (hazard ratio, 1.49) compared with nonuse.
- Gabapentinoid use was associated with a significantly increased COPD exacerbation risk for each group of users compared with nonusers, with hazard ratios of 1.58, 1.35, and 1.49 for epilepsy, neuropathic pain, and other chronic pain, respectively.
IN PRACTICE:
“This study supports the warnings from regulatory agencies and highlights the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the researchers wrote.
SOURCE:
The lead author on the study was Alvi A. Rahman, MSc, of Jewish General Hospital, Montreal. The study was published online on January 16, 2024, in Annals of Internal Medicine.
LIMITATIONS:
A lack of data on smoking status and other residual confounding factors limited the study findings.
DISCLOSURES:
The study was supported by the Canadian Institutes of Health Research and the Canadian Lung Association. Mr. Rahman had no financial conflicts to disclose, but some coauthors disclosed consulting and advisory relationships with various companies, including Merck, Pfizer, Seqirus, Boehringer-Ingelheim, and Novartis outside of the current work.
A version of this article appeared on Medscape.com.