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More evidence dementia not linked to PPI use in older people
Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.
Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .
Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.
“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.
“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
Growing use, growing concern
As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.
“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.
Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.
The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.
To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.
The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.
“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.
They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.
Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.
All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.
At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
Key points
During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.
Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).
“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.
When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.
Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.
To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.
A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.
In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
Why the different findings?
The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.
Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”
“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”
The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.
“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”
Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.
Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .
Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.
“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.
“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
Growing use, growing concern
As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.
“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.
Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.
The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.
To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.
The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.
“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.
They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.
Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.
All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.
At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
Key points
During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.
Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).
“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.
When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.
Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.
To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.
A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.
In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
Why the different findings?
The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.
Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”
“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”
The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.
“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”
Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Controversy regarding the purported link between the use of proton pump inhibitors (PPIs) or histamine H2 receptor antagonists (H2RAs) and risk for dementia continues.
Adding to the “no link” column comes new evidence from a study presented at the annual Digestive Disease Week® (DDW) .
Among almost 19,000 people, no association was found between the use of these agents and a greater likelihood of incident dementia, Alzheimer’s disease, or cognitive decline in people older than 65 years.
“We found that baseline PPI or H2RA use in older adults was not associated with dementia, with mild cognitive impairment, or declines in cognitive scores over time,” said lead author Raaj Shishir Mehta, MD, a gastroenterology fellow at Massachusetts General Hospital in Boston.
“While deprescribing efforts are important, especially when medications are not indicated, these data provide reassurance about the cognitive impacts of long-term use of PPIs in older adults,” he added.
Growing use, growing concern
As PPI use has increased worldwide, so too have concerns over the adverse effects from their long-term use, Dr. Mehta said.
“One particular area of concern, especially among older adults, is the link between long-term PPI use and risk for dementia,” he said.
Igniting the controversy was a February 2016 study published in JAMA Neurology that showed a positive association between PPI use and dementia in residents of Germany aged 75 years and older. Researchers linked PPI use to a 44% increased risk of dementia over 5 years.
The 2016 study was based on claims data, which can introduce “inaccuracy or bias in defining dementia cases,” Dr. Mehta said. He noted that it and other previous studies also were limited by an inability to account for concomitant medications or comorbidities.
To overcome these limitations in their study, Dr. Mehta and colleagues analyzed medication data collected during in-person visits and asked experts to confirm dementia outcomes. The research data come from ASPREE, a large aspirin study of 18,846 people older than 65 years in the United States and Australia. Participants were enrolled from 2010 to 2014. A total of 566 people developed incident dementia during follow-up.
The researchers had data on alcohol consumption and other lifestyle factors, as well as information on comorbidities, hospitalizations, and overall well-being.
“Perhaps the biggest strength of our study is our rigorous neurocognitive assessments,” Dr. Mehta said.
They assessed cognition at baseline and at years 1, 3, 5, and 7 using a battery of tests. An expert panel of neurologists, neuropsychologists, and geriatricians adjudicated cases of dementia, in accordance with DSM-IV criteria. If the diagnosis was unclear, they referred people for additional workup, including neuroimaging.
Cox proportional hazards, regression, and/or mixed effects modeling were used to relate medication use with cognitive scores.
All analyses were adjusted for age, sex, body mass index, alcohol use, family history of dementia, medications, and other medical comorbidities.
At baseline, PPI users were more likely to be White, have fewer years of education, and have higher rates of hypertension, diabetes, and kidney disease. This group also was more likely to be taking five or more medications.
Key points
During 80,976 person-years of follow-up, there were 566 incident cases of dementia, including 235 probable cases of Alzheimer’s disease and 331 other dementias.
Baseline PPI use, in comparison with nonuse, was not associated with incident dementia (hazard ratio, 0.86; 95% confidence interval, 0.70-1.05).
“Similarly, when we look specifically at Alzheimer’s disease or mixed types of dementia, we find no association between baseline PPI use and dementia,” Dr. Mehta said.
When they excluded people already taking PPIs at baseline, they found no association between starting PPIs and developing dementia over time.
Secondary aims of the study included looking for a link between PPI use and mild cognitive impairment or significant changes in cognition over time. In both cases, no association emerged. PPI use at baseline also was not associated with cognitive impairment/no dementia (also known as mild cognitive impairment) or with changes in overall cognitive test scores over time.
To determine whether any association could be a class effect of acid suppression medication, they assessed use of H2RA medications and development of incident dementia. Again, the researchers found no link.
A diverse multinational population from urban and rural areas was a strength of the study, as was the “very rigorous cognitive testing with expert adjudication of our endpoints,” Dr. Mehta said. In addition, fewer than 5% of patients were lost to follow-up.
In terms of limitations, this was an observational study “so residual confounding is always possible,” he added. “But I’ll emphasize that we are among the largest studies to date with wealth of covariates.”
Why the different findings?
The study was “really well done,” session moderator Paul Moayyedi, MD, said during the Q&A session at DDW 2022.
Dr. Moayyedi, a professor of medicine at McMaster University, Hamilton, Ont., asked Dr. Mehta why he “found absolutely no signal, whereas the German study did.”
“It’s a good question,” Dr. Mehta responded. “If you look across the board, there have been conflicting results.”
The disparity could be related to how researchers conducting claims data studies classify dementia, he noted.
“If you look at the nitty-gritty details over 5 years, almost 40% of participants [in those studies] end up with a diagnosis of dementia, which is quite high,” Dr. Mehta said. “That raises questions about whether the diagnosis of dementia is truly accurate.”
Dr. Mehta and Dr. Moayyedi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DDW 2022
APA targets structural racism, offers solutions
, released to coincide with the annual meeting of the American Psychiatric Association.
The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note.
“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.
“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.
Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
A new agenda for change
In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.
Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.
Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.
They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.
Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
A national conversation
Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.
Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.
However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.
The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.
“Ultimately, only structural solutions can dismantle structural racism,” they wrote.
The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.
“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing.
“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.
The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, released to coincide with the annual meeting of the American Psychiatric Association.
The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note.
“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.
“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.
Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
A new agenda for change
In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.
Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.
Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.
They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.
Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
A national conversation
Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.
Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.
However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.
The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.
“Ultimately, only structural solutions can dismantle structural racism,” they wrote.
The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.
“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing.
“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.
The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, released to coincide with the annual meeting of the American Psychiatric Association.
The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note.
“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.
“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.
Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
A new agenda for change
In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.
Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.
Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.
They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.
Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
A national conversation
Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.
Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.
However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.
The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.
“Ultimately, only structural solutions can dismantle structural racism,” they wrote.
The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.
“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing.
“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.
The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
No-implant interatrial shunt remains patent at a year
The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.
Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).
“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)
The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).
The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.
Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.
“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.
None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”
Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.
“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added.
Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.
Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).
“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)
The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).
The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.
Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.
“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.
None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”
Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.
“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added.
Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
The first in-human trials of a no-implant approach to interatrial shunting to alleviate heart failure symptoms have shown a signal that the procedure reduces peak exercise wedge pressure in recipients a month afterward, according to early trial results.
Colin M. Barker, MD, reported 30-day results of 31 patients who had no-implant interatrial shunting for heart failure across three studies, at the Society for Cardiovascular Angiography & Interventions scientific sessions. The studies included patients with HF with preserved and reduced ejection fraction (HFpEF and HFrEF).
“At 30 days, there was a response with a decrease in the wedge pressures both at rest and at peak exercise, and that was consistent through all three of these initial trials,” Dr. Barker said. In all 33 patients who have been treated to date, there were no major adverse cardiac and cerebrovascular or thromboembolic events through 1 month. (Two of the patients weren’t included in the results Dr. Barker presented.)
The three studies he reported on were the Alleviate-HF-1 (n = 15), Alleviate-HF-2 (n = 11) for patients with HFpEF, and Alleviate-HFrEF (n = 5). The average patient age was 67 years, and all were New York Heart Association class II, III, or IV with elevated peak pulmonary capillary wedge pressure (PCWP).
The device that creates the no-implant shunt as “not very exotic, but it is very effective, and what it does is create a very predictable, reproducible atrial septostomy” between the left and right atria. The device obtains “almost a biopsy” that’s 7 mm in diameter. “There’s no hardware or foreign bodies left inside the patient,” said Dr. Barker, director of interventional cardiology at Vanderbilt University in Nashville, Tenn. “There’s a natural healing process at the rims after the radiofrequency ablation has been done.” Femoral access was used.
Study participants were also asked to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and at 1 and 3 months across all three studies, and at 6 months in the Alleviate-HF-1 study. “Just as important is how patients feel,” Dr. Barker said. KCCQ overall summary scores increased at each time interval across all three studies.
“Durability has been proven with multiple different imaging modalities,” Dr. Barker added, explaining that CT scans in 10 of 10 shunts demonstrated patency through 12 months, and 15 of 15 at 6 months. He noted that none of the created shunts have closed yet. At 6 months, the average shunt measured 7.5 mm (± 1.1 mm, n = 22), left atrial diameter decreased 2.4 mm (P = .031) in HFpEF patients, and no significant changes were observed in right ventricular fractional area change or right atrial volume index.
None of the septostomies have had to be closed or enlarged to date, Dr. Barker said. “We are creating an atrial septal defect that we have a lot of comfort and experience with closing with other devices if need be, but that hasn’t been an issue,” he said. “As of now, it’s one size, but as you can imagine, one-size-fits-all is not the way this will go, and this does allow for variations in size ultimately.”
Kirk N. Garratt, MD, director of the Center for Heart and Vascular Health at Christiana Care in Newark, Del., noted that the approach to unload the left atrium “is novel, but I think is becoming well accepted in the advanced HF population. There remain questions about long-term consequences of an intentional interatrial shunt – what happens to pulmonary flow dynamics and the like – but to date the impact of this approach has been favorable.
“The liabilities that come with an implanted device in the septal space, both in terms of the durability of the shunt and the impact that it would have on the ability to perform other transseptal procedures, is overcome with this approach,” he added.
Dr. Barker disclosed he is an advisory board member and consultant to Alleviant Medical. Dr. Garratt is an advisory board member for Abbott.
FROM SCAI 2022
Disasters abroad a major trigger for mental illness in expats
The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.
The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.
“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
A historic explosion
It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.
“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”
Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.
She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.
“That prompted us to look at expatriate mental health following this traumatic incident,” she said.
She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.
She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.
The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.
Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.
The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
No tincture of time
Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.
Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).
Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.
The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.
“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.
Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
Global psychiatrist shortage
Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”
It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”
In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.
Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.
The researchers and Dr. Liu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.
The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.
“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
A historic explosion
It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.
“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”
Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.
She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.
“That prompted us to look at expatriate mental health following this traumatic incident,” she said.
She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.
She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.
The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.
Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.
The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
No tincture of time
Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.
Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).
Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.
The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.
“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.
Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
Global psychiatrist shortage
Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”
It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”
In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.
Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.
The researchers and Dr. Liu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.
The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.
“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
A historic explosion
It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.
“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”
Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.
She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.
“That prompted us to look at expatriate mental health following this traumatic incident,” she said.
She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.
She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.
The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.
Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.
The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
No tincture of time
Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.
Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).
Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.
The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.
“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.
Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
Global psychiatrist shortage
Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”
It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”
In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.
Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.
The researchers and Dr. Liu reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM APA 2022
Vibrating pill counters constipation
A swallowable, vibrating capsule improved symptoms among patients with chronic idiopathic constipation in a phase 3 multicenter, randomized, controlled trial. The method represents a mechanical approach to the treatment of constipation.
The swallowable pill acts by vibrating during passage through the gut, where it is thought to augment colonic biorhythm and peristalsis. Traditional treatments for constipation generally increase motility or secretion.
“That’s how we have been managing constipation since time immemorial. Now we have come up with this novel approach, where there’s a pill that is designed to increase local oscillations, and probably induce local contractions of the colon to mimic what happens normally,” said Satish Rao, MD, PhD, who presented the results of the trial at the annual Digestive Disease Week® (DDW).
“We’re now seeing that local stimulation works, and the other neat thing seems to be a lack of side effects, which is really a huge plus. I think it will benefit people with both occasional or chronic constipation,” said Dr. Rao, professor of medicine at Medical College of Georgia, Augusta.
The capsules activate for two stimulation cycles, each lasting for about 2 hours. The cycle includes 3 seconds of vibration followed by 16 seconds of rest.
The researchers conducted a study with two active arms and a placebo. It included 312 patients age 22 or older who had an average of between 1 and 2.5 spontaneous bowel movements (SBM) per week.
Treatment lasted for 8 weeks, with patients ingesting a capsule between 9 and 10 p.m. In one treatment group, the device was activated at 6 a.m., and in the other group at about 2 p.m.
The placebo and treatment groups had similar baseline characteristics, except for a longer duration of constipation in the treatment groups (17.9 versus 14.5 years; P = .0253). In an intention-to-treat analysis, the treatment groups were more likely to achieve an increase of one complete SBM per week (39.26% versus 22.15%; P < .0001) and an increase of two complete SBMs per week (22.7% versus 11.41%; P < .0006).
The capsules also improved straining score, stool consistency, and quality of life. There was no significant difference between treatment and placebo groups with respect to bloating or rescue medication use.
The product had few adverse effects. The most common was a vibrating sensation or discomfort (11.0%, versus none in the placebo group).
Dr. Rao expects that the treatment could be widely applicable since many constipation patients don’t gain sufficient benefit from existing treatments, or find side effects intolerable.
Another benefit is that the therapy’s mimicry of natural cycles appears to grant patients more control of bowel movements. Laxatives and other pharmaceutical interventions may prompt the patient to go to the bathroom within an hour or two, but patients in the trial reported bowel movements at predictable times.
However, he noted that the pill is nondissolvable, which would make it contraindicated for patients who have had previous gut surgeries or narrowing of the gut. He noted that the sponsoring company, Vibrant Gastro, expects to obtain Food and Drug Administration approval by the end of 2022.
The results of the study were well received. “I think it’s an exciting new approach for managing patients with chronic constipation. It was a large sample size, and the treatment seems to be well tolerated. It may offer a promising option for patients who have not responded to many other medications,” said Adil E. Bharucha, MD, who comoderated the session where the research was presented.
However, he pointed out that the presentation did not indicate how many of the patients had previously tried other therapies. “We’d like to see the full paper, which will provide a better understanding of the role of this treatment in practice down the road,” said Dr. Bharucha, professor of medicine in the division of gastroenterology and hepatology and director of the office of clinical trials at Mayo Clinic, Rochester, Minn.
The capsule may not work for everyone, said Dr. Bharucha. He suspects that many refractory patients have an issue with pelvic floor muscles, which may restrict stool evacuation. “You wouldn’t expect those people to respond optimally to a laxative and I suspect perhaps not to a capsule, either. I think defecatory disorders are substantially underdiagnosed in patients who don’t respond to laxatives,” said Dr. Bharucha.
Asked why the capsule might benefit patients who don’t improve with laxatives, Dr. Bharucha responded: “I think we need more studies to understand how the capsule works.”
Dr. Rao consults for Vibrant Gastro. Dr. Bharucha has no relevant financial disclosures.
A swallowable, vibrating capsule improved symptoms among patients with chronic idiopathic constipation in a phase 3 multicenter, randomized, controlled trial. The method represents a mechanical approach to the treatment of constipation.
The swallowable pill acts by vibrating during passage through the gut, where it is thought to augment colonic biorhythm and peristalsis. Traditional treatments for constipation generally increase motility or secretion.
“That’s how we have been managing constipation since time immemorial. Now we have come up with this novel approach, where there’s a pill that is designed to increase local oscillations, and probably induce local contractions of the colon to mimic what happens normally,” said Satish Rao, MD, PhD, who presented the results of the trial at the annual Digestive Disease Week® (DDW).
“We’re now seeing that local stimulation works, and the other neat thing seems to be a lack of side effects, which is really a huge plus. I think it will benefit people with both occasional or chronic constipation,” said Dr. Rao, professor of medicine at Medical College of Georgia, Augusta.
The capsules activate for two stimulation cycles, each lasting for about 2 hours. The cycle includes 3 seconds of vibration followed by 16 seconds of rest.
The researchers conducted a study with two active arms and a placebo. It included 312 patients age 22 or older who had an average of between 1 and 2.5 spontaneous bowel movements (SBM) per week.
Treatment lasted for 8 weeks, with patients ingesting a capsule between 9 and 10 p.m. In one treatment group, the device was activated at 6 a.m., and in the other group at about 2 p.m.
The placebo and treatment groups had similar baseline characteristics, except for a longer duration of constipation in the treatment groups (17.9 versus 14.5 years; P = .0253). In an intention-to-treat analysis, the treatment groups were more likely to achieve an increase of one complete SBM per week (39.26% versus 22.15%; P < .0001) and an increase of two complete SBMs per week (22.7% versus 11.41%; P < .0006).
The capsules also improved straining score, stool consistency, and quality of life. There was no significant difference between treatment and placebo groups with respect to bloating or rescue medication use.
The product had few adverse effects. The most common was a vibrating sensation or discomfort (11.0%, versus none in the placebo group).
Dr. Rao expects that the treatment could be widely applicable since many constipation patients don’t gain sufficient benefit from existing treatments, or find side effects intolerable.
Another benefit is that the therapy’s mimicry of natural cycles appears to grant patients more control of bowel movements. Laxatives and other pharmaceutical interventions may prompt the patient to go to the bathroom within an hour or two, but patients in the trial reported bowel movements at predictable times.
However, he noted that the pill is nondissolvable, which would make it contraindicated for patients who have had previous gut surgeries or narrowing of the gut. He noted that the sponsoring company, Vibrant Gastro, expects to obtain Food and Drug Administration approval by the end of 2022.
The results of the study were well received. “I think it’s an exciting new approach for managing patients with chronic constipation. It was a large sample size, and the treatment seems to be well tolerated. It may offer a promising option for patients who have not responded to many other medications,” said Adil E. Bharucha, MD, who comoderated the session where the research was presented.
However, he pointed out that the presentation did not indicate how many of the patients had previously tried other therapies. “We’d like to see the full paper, which will provide a better understanding of the role of this treatment in practice down the road,” said Dr. Bharucha, professor of medicine in the division of gastroenterology and hepatology and director of the office of clinical trials at Mayo Clinic, Rochester, Minn.
The capsule may not work for everyone, said Dr. Bharucha. He suspects that many refractory patients have an issue with pelvic floor muscles, which may restrict stool evacuation. “You wouldn’t expect those people to respond optimally to a laxative and I suspect perhaps not to a capsule, either. I think defecatory disorders are substantially underdiagnosed in patients who don’t respond to laxatives,” said Dr. Bharucha.
Asked why the capsule might benefit patients who don’t improve with laxatives, Dr. Bharucha responded: “I think we need more studies to understand how the capsule works.”
Dr. Rao consults for Vibrant Gastro. Dr. Bharucha has no relevant financial disclosures.
A swallowable, vibrating capsule improved symptoms among patients with chronic idiopathic constipation in a phase 3 multicenter, randomized, controlled trial. The method represents a mechanical approach to the treatment of constipation.
The swallowable pill acts by vibrating during passage through the gut, where it is thought to augment colonic biorhythm and peristalsis. Traditional treatments for constipation generally increase motility or secretion.
“That’s how we have been managing constipation since time immemorial. Now we have come up with this novel approach, where there’s a pill that is designed to increase local oscillations, and probably induce local contractions of the colon to mimic what happens normally,” said Satish Rao, MD, PhD, who presented the results of the trial at the annual Digestive Disease Week® (DDW).
“We’re now seeing that local stimulation works, and the other neat thing seems to be a lack of side effects, which is really a huge plus. I think it will benefit people with both occasional or chronic constipation,” said Dr. Rao, professor of medicine at Medical College of Georgia, Augusta.
The capsules activate for two stimulation cycles, each lasting for about 2 hours. The cycle includes 3 seconds of vibration followed by 16 seconds of rest.
The researchers conducted a study with two active arms and a placebo. It included 312 patients age 22 or older who had an average of between 1 and 2.5 spontaneous bowel movements (SBM) per week.
Treatment lasted for 8 weeks, with patients ingesting a capsule between 9 and 10 p.m. In one treatment group, the device was activated at 6 a.m., and in the other group at about 2 p.m.
The placebo and treatment groups had similar baseline characteristics, except for a longer duration of constipation in the treatment groups (17.9 versus 14.5 years; P = .0253). In an intention-to-treat analysis, the treatment groups were more likely to achieve an increase of one complete SBM per week (39.26% versus 22.15%; P < .0001) and an increase of two complete SBMs per week (22.7% versus 11.41%; P < .0006).
The capsules also improved straining score, stool consistency, and quality of life. There was no significant difference between treatment and placebo groups with respect to bloating or rescue medication use.
The product had few adverse effects. The most common was a vibrating sensation or discomfort (11.0%, versus none in the placebo group).
Dr. Rao expects that the treatment could be widely applicable since many constipation patients don’t gain sufficient benefit from existing treatments, or find side effects intolerable.
Another benefit is that the therapy’s mimicry of natural cycles appears to grant patients more control of bowel movements. Laxatives and other pharmaceutical interventions may prompt the patient to go to the bathroom within an hour or two, but patients in the trial reported bowel movements at predictable times.
However, he noted that the pill is nondissolvable, which would make it contraindicated for patients who have had previous gut surgeries or narrowing of the gut. He noted that the sponsoring company, Vibrant Gastro, expects to obtain Food and Drug Administration approval by the end of 2022.
The results of the study were well received. “I think it’s an exciting new approach for managing patients with chronic constipation. It was a large sample size, and the treatment seems to be well tolerated. It may offer a promising option for patients who have not responded to many other medications,” said Adil E. Bharucha, MD, who comoderated the session where the research was presented.
However, he pointed out that the presentation did not indicate how many of the patients had previously tried other therapies. “We’d like to see the full paper, which will provide a better understanding of the role of this treatment in practice down the road,” said Dr. Bharucha, professor of medicine in the division of gastroenterology and hepatology and director of the office of clinical trials at Mayo Clinic, Rochester, Minn.
The capsule may not work for everyone, said Dr. Bharucha. He suspects that many refractory patients have an issue with pelvic floor muscles, which may restrict stool evacuation. “You wouldn’t expect those people to respond optimally to a laxative and I suspect perhaps not to a capsule, either. I think defecatory disorders are substantially underdiagnosed in patients who don’t respond to laxatives,” said Dr. Bharucha.
Asked why the capsule might benefit patients who don’t improve with laxatives, Dr. Bharucha responded: “I think we need more studies to understand how the capsule works.”
Dr. Rao consults for Vibrant Gastro. Dr. Bharucha has no relevant financial disclosures.
FROM DDW 2022
Thrombolysis is safe in stroke patients on oral anticoagulants
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a new observational study suggests, prompting researchers to ask whether guidelines that restrict its use should be updated.
Researchers found that DOAC users were significantly less likely to develop symptomatic intracerebral hemorrhage (sICH) after IVT, and there was no difference in functional independence at 3 months, compared with patients who received IVT but who did not receive DOAC.
“At the moment, the guidelines really pose a barrier and stop sign in front of the most important medical reperfusion therapy, which is thrombolysis,” said principal investigator Jan Purrucker, MD, professor of neurology at Heidelberg University Hospital.
“The main question we have to answer is, is IVT safe in patients with acute ischemic stroke who were pretreated with direct oral anticoagulants or not?”
The findings were presented at the European Stroke Organisation Conference (ESOC) 2022, Lyon, France.
A ‘daily clinical problem’
As many as 20% of patients with atrial fibrillation experience ischemic stroke while receiving DOAC therapy. Reperfusion therapy with intravenous alteplase is considered standard of care for acute ischemic stroke, but current guidelines recommend against the use of IVT for patients who have recently received a DOAC, owing to safety concerns that researchers say are not backed by strong clinical evidence.
A recent study found no significant difference in sICH among patients who received IV alteplase for acute ischemic stroke within 7 days of receiving therapy with non–vitamin K antagonist oral anticoagulants.
“In our daily clinical practice, we face a lot of patients who have received oral anticoagulation, many with atrial fibrillation, but a lot of other indicators as well, and they suffer from ischemic stroke,” Dr. Purrucker said. “They usually are ineligible for medical reperfusion therapy because of quite strict guideline recommendations at the moment. This is a daily clinical problem.”
Dr. Purrucker and colleagues in New Zealand and Switzerland launched an international, observational, multicenter cohort study to examine the issue.
Researchers collected data on patients with ischemic stroke who had last received DOAC therapy 48 hours or less before the event or whose last intake was unknown and who had received IVT. They included 20,448 patients, 830 of whom were receiving DOAC therapy at the time of stroke onset.
Among the DOAC users, 30% received DOAC reversal prior to IVT, 27% had their DOAC level measured, and 42% received IVT without reversal treatment or knowledge of DOAC levels.
Overall, 4.5% of patients developed sICH. Compared with the control group, DOAC users were half as likely to develop sICH (adjusted odds ratio, 0.47; P = .003).
There was no significant difference between groups in independent outcome at 3 months, defined as a Modified Rankin Scale score of 1 to 3 (aOR, 1.21; 95% confidence interval, 0.99-1.49).
This finding held across patient subgroups, including patients for whom selection methods differed and patients with very recent intake of less than 12 hours.
“The question is whether we are so confident in these data that we would change our clinical practice now,” Dr. Purrucker said.
Infrastructure needed
While the findings are promising, more data are needed to strengthen the argument for revising current IVT guidelines, said Ho-Yan Yvonne Chun, PhD, honorary senior clinical lecturer with the Centre for Clinical Brain Sciences at the University of Edinburgh and a consultant in stroke medicine for NHS Lothian and Borders General Hospital, who commented on the findings.
“The study sample are a highly selected group of patients from selected centers that have the infrastructure to offer DOAC level checking and DOAC reversal,” Dr. Chun said. “The selected centers are not representative of the majority of hospitals that offer IVT to stroke patients with acute stroke.”
Most hospitals lack the equipment necessary to test DOAC levels and don’t have immediate access to DOAC reversal agents, Dr. Chun said. In those centers, she added, the administration of IVT could be delayed, which might affect clinical outcomes.
“Infrastructure needs to be in place to ensure timely delivery of IVT to these patients,” Dr. Chun added. “This means that in real-world practice, hospitals need to have right logistical pathway in place in order to provide timely DOAC level checking and DOAC reversal agents.”
Dr. Chun added that “large pragmatic clinical trials, preferably multicentered, are needed to provide the definitive evidence on the safety and effectiveness of using these approaches to select patients with prior DOAC use for IVT.”
But such a study may not be feasible, Dr. Purrucker said. Among the hurdles he noted are the large sample size needed for such a trial, uncertainty regarding funding, and patient selection bias, resulting from the fact that such studies would likely exclude patients eligible for mechanical thrombectomy or those eligible for reversal treatment.
In light of earlier studies, including preclinical data that support the safety of DOACs in IVT, and these new data, Dr. Purrucker said he hopes a change in guidelines might be taken up in the future.
“But it should be good academic practice to first let the results be externally evaluated, for example, during the manuscript submission process,” he said. “But once published, guideline working groups will have to evaluate the recent and new evidence and might reconsider previous recommendations.”
The study received no commercial funding. Dr. Purrucker and Dr. Chun reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ESOC 2022
Videos may not increase vaccinations in IBD
SAN DIEGO – Video and text messaging may not increase the proportion of people with inflammatory bowel disease (IBD) who get influenza vaccinations.
Although patients who received the messages expressed greater intention to get the vaccinations in a trial of the two methods, they didn’t follow through and get the shots, said Keren Appel, MD, a pediatric gastroenterologist at Children’s Hospital of Orange County in Orange, Calif.
“We found there was no difference in the uptake of the influenza vaccine between the two groups,” she said in an interview. Dr. Appel, who participated in the research while at Cedars-Sinai Medical Center in Los Angeles, presented the finding at the annual Digestive Diseases Week® (DDW) 2022.
People with IBD run an increased risk of complications such as infection, bone fractures, and cancer, said Dr. Appel. Previous research has suggested many people with IBD lack understanding or awareness or are skeptical of immunizations.
A previous trial with text-based email reminders did not result in more immunizations, according to Dr. Appel, so she and her colleagues decided to try promoting health prevention with videos. With feedback from patients, they created a series of animations encouraging patients to get influenza, pneumococcal, and zoster vaccinations and screening for bone health and skin cancer.
They randomly assigned 511 to receive videos and 545 patients to receive texts as a control group. After 6 months, 345 patients remained in the text group and 322 remained in the video group. The two groups had similar demographics, health status, and preventive health behaviors. They were mostly educated White women whose IBD was in remission.
The percentage of those who got flu vaccines increased from 59% (for the 2018-2019 season) to 63% (for the 2019-2020 flu season) in the group that watched the videos. However this change did not quite reach statistical significance (P = .07). The change in the text group, from 55% to 57%, was also not significant (P = .23).
The subjects did express more intention to get flu vaccines. The percentage with this intention increased from 59 to 75 in the video group, and from 55 to 72 in the text group. Both changes were statistically significant (P < .001).
Intentions to receive pneumonia and shingles vaccines, and bone and skin cancer screening, were not statistically different between the groups.
The researchers looked at age, immunosuppression, gender, and education to see if these factors could predict who was most likely to get the flu vaccine, but the only significant predictor was having received a previous flu shot.
Dr. Appel speculated that the videos might have been more effective in a more racially diverse, less educated population, or one where fewer people had previously received vaccinations.
“While we didn’t see a difference in this study, I think it opens up a lot of other questions that we can explore and answer,” she said. “It’s possible that patients may not have a one size fits all on their response. Some may respond better to video. Some may respond to text. Some may need more frequent reminders. Some might need to hear it from their doctor directly.”
Session comoderator Alyse Bedell, PhD, an assistant professor of psychiatry and behavioral neuroscience at the University of Chicago, agreed that a different patient population might have responded differently. “A population that may have lower access to educational resources, or has less educational attainment, or may have fewer people in their communities that are already receiving vaccines – those I think are going to be the populations where we’re going to be more likely to see the effects of an intervention like this,” she said in an interview.
Neither Dr. Appel nor Dr. Bedell reported any relevant financial interests. The study was funded by Pfizer.
SAN DIEGO – Video and text messaging may not increase the proportion of people with inflammatory bowel disease (IBD) who get influenza vaccinations.
Although patients who received the messages expressed greater intention to get the vaccinations in a trial of the two methods, they didn’t follow through and get the shots, said Keren Appel, MD, a pediatric gastroenterologist at Children’s Hospital of Orange County in Orange, Calif.
“We found there was no difference in the uptake of the influenza vaccine between the two groups,” she said in an interview. Dr. Appel, who participated in the research while at Cedars-Sinai Medical Center in Los Angeles, presented the finding at the annual Digestive Diseases Week® (DDW) 2022.
People with IBD run an increased risk of complications such as infection, bone fractures, and cancer, said Dr. Appel. Previous research has suggested many people with IBD lack understanding or awareness or are skeptical of immunizations.
A previous trial with text-based email reminders did not result in more immunizations, according to Dr. Appel, so she and her colleagues decided to try promoting health prevention with videos. With feedback from patients, they created a series of animations encouraging patients to get influenza, pneumococcal, and zoster vaccinations and screening for bone health and skin cancer.
They randomly assigned 511 to receive videos and 545 patients to receive texts as a control group. After 6 months, 345 patients remained in the text group and 322 remained in the video group. The two groups had similar demographics, health status, and preventive health behaviors. They were mostly educated White women whose IBD was in remission.
The percentage of those who got flu vaccines increased from 59% (for the 2018-2019 season) to 63% (for the 2019-2020 flu season) in the group that watched the videos. However this change did not quite reach statistical significance (P = .07). The change in the text group, from 55% to 57%, was also not significant (P = .23).
The subjects did express more intention to get flu vaccines. The percentage with this intention increased from 59 to 75 in the video group, and from 55 to 72 in the text group. Both changes were statistically significant (P < .001).
Intentions to receive pneumonia and shingles vaccines, and bone and skin cancer screening, were not statistically different between the groups.
The researchers looked at age, immunosuppression, gender, and education to see if these factors could predict who was most likely to get the flu vaccine, but the only significant predictor was having received a previous flu shot.
Dr. Appel speculated that the videos might have been more effective in a more racially diverse, less educated population, or one where fewer people had previously received vaccinations.
“While we didn’t see a difference in this study, I think it opens up a lot of other questions that we can explore and answer,” she said. “It’s possible that patients may not have a one size fits all on their response. Some may respond better to video. Some may respond to text. Some may need more frequent reminders. Some might need to hear it from their doctor directly.”
Session comoderator Alyse Bedell, PhD, an assistant professor of psychiatry and behavioral neuroscience at the University of Chicago, agreed that a different patient population might have responded differently. “A population that may have lower access to educational resources, or has less educational attainment, or may have fewer people in their communities that are already receiving vaccines – those I think are going to be the populations where we’re going to be more likely to see the effects of an intervention like this,” she said in an interview.
Neither Dr. Appel nor Dr. Bedell reported any relevant financial interests. The study was funded by Pfizer.
SAN DIEGO – Video and text messaging may not increase the proportion of people with inflammatory bowel disease (IBD) who get influenza vaccinations.
Although patients who received the messages expressed greater intention to get the vaccinations in a trial of the two methods, they didn’t follow through and get the shots, said Keren Appel, MD, a pediatric gastroenterologist at Children’s Hospital of Orange County in Orange, Calif.
“We found there was no difference in the uptake of the influenza vaccine between the two groups,” she said in an interview. Dr. Appel, who participated in the research while at Cedars-Sinai Medical Center in Los Angeles, presented the finding at the annual Digestive Diseases Week® (DDW) 2022.
People with IBD run an increased risk of complications such as infection, bone fractures, and cancer, said Dr. Appel. Previous research has suggested many people with IBD lack understanding or awareness or are skeptical of immunizations.
A previous trial with text-based email reminders did not result in more immunizations, according to Dr. Appel, so she and her colleagues decided to try promoting health prevention with videos. With feedback from patients, they created a series of animations encouraging patients to get influenza, pneumococcal, and zoster vaccinations and screening for bone health and skin cancer.
They randomly assigned 511 to receive videos and 545 patients to receive texts as a control group. After 6 months, 345 patients remained in the text group and 322 remained in the video group. The two groups had similar demographics, health status, and preventive health behaviors. They were mostly educated White women whose IBD was in remission.
The percentage of those who got flu vaccines increased from 59% (for the 2018-2019 season) to 63% (for the 2019-2020 flu season) in the group that watched the videos. However this change did not quite reach statistical significance (P = .07). The change in the text group, from 55% to 57%, was also not significant (P = .23).
The subjects did express more intention to get flu vaccines. The percentage with this intention increased from 59 to 75 in the video group, and from 55 to 72 in the text group. Both changes were statistically significant (P < .001).
Intentions to receive pneumonia and shingles vaccines, and bone and skin cancer screening, were not statistically different between the groups.
The researchers looked at age, immunosuppression, gender, and education to see if these factors could predict who was most likely to get the flu vaccine, but the only significant predictor was having received a previous flu shot.
Dr. Appel speculated that the videos might have been more effective in a more racially diverse, less educated population, or one where fewer people had previously received vaccinations.
“While we didn’t see a difference in this study, I think it opens up a lot of other questions that we can explore and answer,” she said. “It’s possible that patients may not have a one size fits all on their response. Some may respond better to video. Some may respond to text. Some may need more frequent reminders. Some might need to hear it from their doctor directly.”
Session comoderator Alyse Bedell, PhD, an assistant professor of psychiatry and behavioral neuroscience at the University of Chicago, agreed that a different patient population might have responded differently. “A population that may have lower access to educational resources, or has less educational attainment, or may have fewer people in their communities that are already receiving vaccines – those I think are going to be the populations where we’re going to be more likely to see the effects of an intervention like this,” she said in an interview.
Neither Dr. Appel nor Dr. Bedell reported any relevant financial interests. The study was funded by Pfizer.
AT DDW 2022
Innovative med school curriculum could help curb the opioid epidemic
, new research suggests.
“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.
In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”
Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.
“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”
The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.
Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).
The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).
An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.
Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.
“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
Worthwhile, important research
Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.
The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.
Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.
Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”
He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.
Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.
“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”
A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.
“So you want to approach this problem from as many different angles as you can.”
He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.
A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”
The study was supported by the Substance Abuse and Mental Health Services Administration.
A version of this article first appeared on Medscape.com.
, new research suggests.
“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.
In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”
Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.
“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”
The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.
Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).
The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).
An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.
Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.
“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
Worthwhile, important research
Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.
The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.
Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.
Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”
He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.
Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.
“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”
A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.
“So you want to approach this problem from as many different angles as you can.”
He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.
A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”
The study was supported by the Substance Abuse and Mental Health Services Administration.
A version of this article first appeared on Medscape.com.
, new research suggests.
“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.
The findings were presented at the annual meeting of the American Psychiatric Association.
The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.
In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”
Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.
“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”
The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.
Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).
The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).
An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.
Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.
“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
Worthwhile, important research
Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.
The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.
Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.
Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”
He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.
Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.
“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”
A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.
“So you want to approach this problem from as many different angles as you can.”
He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.
A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”
The study was supported by the Substance Abuse and Mental Health Services Administration.
A version of this article first appeared on Medscape.com.
FROM APA 2022
Voice-analysis app promising as early warning system for heart failure decompensation
A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.
The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.
In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.
The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”
Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.
In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.
The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”
On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”
The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.
“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”
“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.
The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.
The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”
But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.
The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.
Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.
About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.
The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.
Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.
Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.
Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.
A version of this article first appeared on Medscape.com.
A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.
The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.
In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.
The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”
Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.
In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.
The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”
On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”
The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.
“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”
“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.
The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.
The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”
But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.
The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.
Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.
About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.
The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.
Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.
Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.
Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.
A version of this article first appeared on Medscape.com.
A voice can carry a long distance, but in patients with heart failure (HF) a voice can also carry otherwise hidden signs useful for predicting short-term risk for worsening disease, even acute decompensation. Potentially, it only has to reach a smartphone to do it, suggests a preliminary study of a mobile app designed to alert patients and clinicians to such looming HF events, if possible in time to avert them.
The proprietary app and analysis system (HearO, Cordio Medical), used daily at home by 180 patients with stable HF, demonstrated 82% accuracy in picking out vocal signals of early congestion that would soon be followed by a need for intensified therapy or acute decompensation.
In practice, clinicians receiving the system’s alerts about altered fluid status would intervene with medication adjustments before the patient deteriorates and possibly heads for the ED. That would be the plan; there were no interventions in the current study, which was designed only to explore the strategy’s feasibility and accuracy.
The system could emerge as “a useful tool in remote monitoring of heart failure patients, providing early warning of worsening heart failure,” said William Abraham, MD, from Ohio State University Wexner Medical Center, Columbus. “It has the potential to reduce acute decompensated heart failure hospitalizations and improve patient quality of life and economic outcomes. But, of course, we have to show that now in larger and randomized clinical studies.”
Abraham presented the Cordio HearO Community Study preliminary results at the Heart Failure Association of the European Society of Cardiology sessions. It follows a recent small study that showed the same app could identify vocal signals linked to altered fluid status in patients with HF hospitalized with acute decompensation.
In the current study, researchers prospectively tracked any worsening HF events that hit patients within a month after the system sent them an alert suggesting early changes in fluid status. Then, they retrospectively assessed the strategy’s predictive accuracy for an initial episode.
The system correctly predicted 32 of 39 first HF events, for an 82% sensitivity and a false-positive rate of 18%. On an annualized basis, Dr. Abraham said, the patients experienced an estimated two to three false alarms per year, alerts that were not followed by HF events. For context, the standard practice of monitoring the patient’s weight “has a sensitivity of about 10%-20%. So this performs very well as a noninvasive technology.”
On average, Dr. Abraham said, “we were able to detect future events about 18 days prior to the worsening heart failure event,” which in practice would provide “a pretty broad window for intervention.”
The false positives were not a surprise. Lung fluid status can change in conditions other than heart failure, he observed, and the HearO system alerts aren’t meant to be followed blindly.
“I don’t know that we clearly understand what those false-positives represent just yet,” Dr. Abraham said. “The bottom line is, as with any diagnostic tool, you have to use the totality of clinical information you have available. If you get an alert and the patient has a fever and a cough, you might think of pneumonia before worsening heart failure.”
“The false positives don’t appear to be alarming,” agreed Antoni Bayés-Genís, MD, PhD, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, and Universitat Autònoma de Barcelona.
The study suggests that the HearO system, combined with sound clinical judgment, “has the potential to identify early congestion that may allow for treatment management, and then avoiding hospital admission,” Dr. Bayés-Genís, who isn’t connected with the study, said in an interview.
The entirely noninvasive, smartphone-based app would be more appealing than implanted devices that, for example, measure thoracic bioimpedance or pulmonary artery pressure and are also intended as congestion early-warning systems, he proposed. “Its scalability makes it very attractive as well.”
But all that “would have to be validated in a large clinical trial,” Dr. Bayés-Genís, who comoderated the conference session featuring Dr. Abraham’s presentation, said when interviewed.
The ongoing study has enrolled 430 clinically stable adult patients with HF in New York Heart Association functional class II or III, regardless of left ventricular ejection fraction, who were cared for by teams at eight centers in Israel. At the outset, during a period of stability, each patient spoke a few sentences into the app to establish a vocal-pattern baseline.
Once home, their assignment was to speak the same sentences into their phones once a day. The app, working through a cloud-based, artificial intelligence–derived processing system, compared each day’s vocal signature with the baseline and alerted researchers when it detected signs of altered fluid status.
About 460,000 recordings were collected from the 180 patients in the current analysis, of whom about 27% were women. They used the app for a mean of 512 days.
The system seems to work well regardless of language or dialect, Dr. Abraham said. About 70% of the current study’s patients spoke Hebrew, and most of the rest spoke either Russian or Arabic.
Most patients (almost 80%) used the app at least 70% of the prescribed time. Only 14 patients used the app less than 60% of the time, he reported.
Dr. Bayés-Genís proposed that, in practice, unfamiliarity with or resistance to smartphone technology would be unlikely to figure greatly in any nonadherence with the daily app regimen, except “maybe for the eldest of the eldest.” The current cohort’s mean age was 70 years. In his experience, he said, most older persons younger than age 80 use a smartphone, at least in more developed countries.
Dr. Abraham disclosed serving on an advisory board for and receiving consulting fees from Cordio Medical; receiving consulting fees from Abbott, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and Respicardia; receiving salary from V-Wave Medical; and receiving research support from the National Heart, Lung, and Blood Institute. Dr. Bayés-Genís reported receiving personal fees from AstraZeneca, Vifor-Fresenius, Novartis, Boehringer Ingelheim, Abbott, Roche Diagnostics, and Critical Diagnostics.
A version of this article first appeared on Medscape.com.
FROM ESC HEART FAILURE 2022
Adsorbent offers promise for irritable bowel syndrome diarrhea
SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.
The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.
“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”
Dr. Yiannakou presented the finding at the annual Digestive Diseases Week® (DDW).
Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.
First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.
Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*
Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.
PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.
To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.
The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.
On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.
However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.
There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.
Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.
Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.
“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.
Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”
Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.
*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market.
SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.
The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.
“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”
Dr. Yiannakou presented the finding at the annual Digestive Diseases Week® (DDW).
Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.
First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.
Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*
Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.
PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.
To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.
The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.
On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.
However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.
There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.
Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.
Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.
“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.
Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”
Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.
*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market.
SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.
The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.
“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”
Dr. Yiannakou presented the finding at the annual Digestive Diseases Week® (DDW).
Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.
First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.
Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*
Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.
PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.
To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.
The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.
On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.
However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.
There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.
Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.
Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.
“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.
Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”
Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.
*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market.
AT DDW 2022