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FDA to review dupilumab for treating chronic spontaneous urticaria
The that is inadequately controlled by current standard of care.
CSU is an inflammatory skin condition that causes sudden hives and angioedema, most often on the face, hands, and feet. However, the throat and upper airways also can be affected. CSU is generally treated with H1 antihistamines, but this strategy is insufficient for approximately 50% of patients, according to a press release from the manufacturer, Regeneron, announcing the FDA acceptance of the application on March 7.
Dupilumab (Dupixent), first approved in 2017 for treating atopic dermatitis in adults, is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways.
The application for FDA approval for CSU is based on data from a pair of phase 3 trials in two different populations, LIBERTY-CUPID A and B.
The first study (LIBERTY-CUPID A) randomized 138 CSU patients aged 6 years and older who were uncontrolled on antihistamines to additional treatment with dupilumab or placebo over 24 weeks. The dupilumab-treated patients showed a 63% reduction in itch severity compared with a 35% reduction in patients who received the placebo, measured by changes in a 0-21 itch severity scale, according to data presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting.
Patients in the dupilumab group also showed a 65% reduction in the severity of urticaria activity (itch and hives) compared with 37% of those on placebo. Overall rates of adverse events were similar between groups; the most common were injection site reactions, according to the company.
The second study (LIBERTY-CUPID B) assessed efficacy and safety of dupilumab in 108 patients with CSU aged 12-80 years who were symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to the anti-IgE antibody omalizumab (Xolair), approved for CSU. Last year, the company announced that this study had been halted after an interim analysis found that while there were positive numerical trends in reducing itch and hives, they “did not meet statistical significance.” In the March 7 press release, the company said that results from this study provide “additional supporting data” for the approval application.
The target date for the FDA’s decision is Oct. 22, 2023, according to Regeneron. Regeneron and Sanofi also are investigating dupilumab for treating chronic inducible urticaria triggered by cold in a phase 3 study.
The that is inadequately controlled by current standard of care.
CSU is an inflammatory skin condition that causes sudden hives and angioedema, most often on the face, hands, and feet. However, the throat and upper airways also can be affected. CSU is generally treated with H1 antihistamines, but this strategy is insufficient for approximately 50% of patients, according to a press release from the manufacturer, Regeneron, announcing the FDA acceptance of the application on March 7.
Dupilumab (Dupixent), first approved in 2017 for treating atopic dermatitis in adults, is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways.
The application for FDA approval for CSU is based on data from a pair of phase 3 trials in two different populations, LIBERTY-CUPID A and B.
The first study (LIBERTY-CUPID A) randomized 138 CSU patients aged 6 years and older who were uncontrolled on antihistamines to additional treatment with dupilumab or placebo over 24 weeks. The dupilumab-treated patients showed a 63% reduction in itch severity compared with a 35% reduction in patients who received the placebo, measured by changes in a 0-21 itch severity scale, according to data presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting.
Patients in the dupilumab group also showed a 65% reduction in the severity of urticaria activity (itch and hives) compared with 37% of those on placebo. Overall rates of adverse events were similar between groups; the most common were injection site reactions, according to the company.
The second study (LIBERTY-CUPID B) assessed efficacy and safety of dupilumab in 108 patients with CSU aged 12-80 years who were symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to the anti-IgE antibody omalizumab (Xolair), approved for CSU. Last year, the company announced that this study had been halted after an interim analysis found that while there were positive numerical trends in reducing itch and hives, they “did not meet statistical significance.” In the March 7 press release, the company said that results from this study provide “additional supporting data” for the approval application.
The target date for the FDA’s decision is Oct. 22, 2023, according to Regeneron. Regeneron and Sanofi also are investigating dupilumab for treating chronic inducible urticaria triggered by cold in a phase 3 study.
The that is inadequately controlled by current standard of care.
CSU is an inflammatory skin condition that causes sudden hives and angioedema, most often on the face, hands, and feet. However, the throat and upper airways also can be affected. CSU is generally treated with H1 antihistamines, but this strategy is insufficient for approximately 50% of patients, according to a press release from the manufacturer, Regeneron, announcing the FDA acceptance of the application on March 7.
Dupilumab (Dupixent), first approved in 2017 for treating atopic dermatitis in adults, is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways.
The application for FDA approval for CSU is based on data from a pair of phase 3 trials in two different populations, LIBERTY-CUPID A and B.
The first study (LIBERTY-CUPID A) randomized 138 CSU patients aged 6 years and older who were uncontrolled on antihistamines to additional treatment with dupilumab or placebo over 24 weeks. The dupilumab-treated patients showed a 63% reduction in itch severity compared with a 35% reduction in patients who received the placebo, measured by changes in a 0-21 itch severity scale, according to data presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting.
Patients in the dupilumab group also showed a 65% reduction in the severity of urticaria activity (itch and hives) compared with 37% of those on placebo. Overall rates of adverse events were similar between groups; the most common were injection site reactions, according to the company.
The second study (LIBERTY-CUPID B) assessed efficacy and safety of dupilumab in 108 patients with CSU aged 12-80 years who were symptomatic despite standard-of-care treatment and were intolerant or incomplete responders to the anti-IgE antibody omalizumab (Xolair), approved for CSU. Last year, the company announced that this study had been halted after an interim analysis found that while there were positive numerical trends in reducing itch and hives, they “did not meet statistical significance.” In the March 7 press release, the company said that results from this study provide “additional supporting data” for the approval application.
The target date for the FDA’s decision is Oct. 22, 2023, according to Regeneron. Regeneron and Sanofi also are investigating dupilumab for treating chronic inducible urticaria triggered by cold in a phase 3 study.
Heart-healthy actions promote longer, disease-free life
Adults who follow a heart-healthy lifestyle are more likely to live longer and to be free of chronic health conditions, based on data from a pair of related studies from the United States and United Kingdom involving nearly 200,000 individuals.
The studies, presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting in Boston, assessed the impact of cardiovascular health on life expectancy and freedom from chronic diseases. Cardiovascular health (CVH) was based on the Life’s Essential 8 (LE8) score, a composite of health metrics released by the American Heart Association in 2022. The LE8 was developed to guide research and assessment of cardiovascular health, and includes diet, physical activity, tobacco/nicotine exposure, sleep, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
In one study, Xuan Wang, MD, a postdoctoral fellow and biostatistician in the department of epidemiology at Tulane University, New Orleans, and colleagues reviewed data from 136,599 adults in the United Kingdom Biobank who were free of cardiovascular disease, diabetes, cancer, and dementia at baseline, and for whom complete LE8 data were available.
CVH was classified as poor, intermediate, and ideal, defined as LE8 scores of less than 50, 50 to 80, and 80 or higher, respectively.
The goal of the study was to examine the role of CVH based on LE8 scores on the percentage of life expectancy free of chronic diseases.
Men and women with ideal CVH averaged 5.2 years and 6.3 years more of total life expectancy at age 50 years, compared with those with poor CVH. Out of total life expectancy, the percentage of life expectancy free of chronic diseases was 75.9% and 83.4% for men and women, respectively, compared with 64.9% and 69.4%, respectively, for men and women with poor CVH.
The researchers also found that disparities in the percentage of disease-free years for both men and women were reduced in the high CVH groups.
The findings were limited by several factors including the use of only CVD, diabetes, cancer, and dementia in the definition of “disease-free life expectancy,” the researchers noted in a press release accompanying the study. Other limitations include the lack of data on e-cigarettes, and the homogeneous White study population. More research is needed in diverse populations who experience a stronger impact from negative social determinants of health, they said.
In a second study, Hao Ma, MD, and colleagues reviewed data from 23,003 adults who participated in the National Health and Nutrition Examination Survey (NHANES) between 2005 and 2018 with mortality linked to the National Death Index through Dec. 31, 2019. The goal of the second study was to examine the association between CVH based on LE8 scores and life expectancy.
Over a median follow-up of 7.8 years, deaths occurred in 772 men and 587 women, said Dr. Ma, a postdoctoral fellow and biostatistician in epidemiology at Tulane University and coauthor on Dr. Wang’s study.
The estimated life expectancies at age 50 years for men with poor, intermediate, and ideal cardiovascular health based on the LE8 were 25.5 years, 31.2 years, and 33.1 years, respectively.
For women, the corresponding life expectancies for women at age 50 with poor, intermediate, and ideal CVH were 29.5 years, 34.2 years, and 38.4 years, respectively.
Men and women had similar gains in life expectancy from adhering to a heart-healthy lifestyle as defined by the LE8 score that reduced their risk of death from cardiovascular disease (41.8% and 44.1%, respectively).
Associations of cardiovascular health and life expectancy were similar for non-Hispanic Whites and non-Hispanic Blacks, but not among people of Mexican heritage, and more research is needed in diverse populations, the researchers wrote.
The study was limited by several factors including potential changes in cardiovascular health during the follow-up period, and by the limited analysis of racial and ethnic groups to non-Hispanic white, non-Hispanic Black, and people of Mexican heritage because of small sample sizes for other racial/ethnic groups, the researchers noted in a press release accompanying the study.
The message for clinicians and their patients is that adherence to cardiovascular health as defined by the LE8 will help not only extend life, but enhance quality of life, Dr. Xang and Dr. Ma said in an interview. “If your overall CVH score is low, we might be able to focus on one element first and improve them one by one,” they said. Sedentary lifestyle and an unhealthy diet are barriers to improving LE8 metrics that can be addressed, they added.
More research is needed to examine the effects of LE8 on high-risk patients, the researchers told this news organization. “No studies have yet focused on these patients with chronic diseases. We suspect that LE8 will play a role even in these high-risk groups,” they said. Further studies should include diverse populations and evaluations of the association between CVH change and health outcomes, they added.
“Overall, we see this 7.5-year difference [in life expectancy] going from poor to high cardiovascular health,” said Donald M. Lloyd-Jones, MD, of Northwestern University, Chicago, in a video accompanying the presentation of the study findings. The impact on life expectancy is yet another reason to motivate people to improve their cardiovascular health, said Dr. Lloyd-Jones, immediate past president of the American Heart Association and lead author on the writing group for Life’s Essential 8. “The earlier we do this, the better, and the greater the gains in life expectancy we’re likely to see in the U.S. population,” he said.
People maintaining high cardiovascular health into midlife are avoiding not only cardiovascular disease, but other chronic diseases of aging, Dr. Lloyd-Jones added. These conditions are delayed until much later in the lifespan, which allows people to enjoy better quality of life for more of their remaining years, he said.
The meeting was sponsored by the American Heart Association.
Both studies were supported by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health; the Fogarty International Center; and the Tulane Research Centers of Excellence Awards. The researchers had no financial conflicts to disclose.
Adults who follow a heart-healthy lifestyle are more likely to live longer and to be free of chronic health conditions, based on data from a pair of related studies from the United States and United Kingdom involving nearly 200,000 individuals.
The studies, presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting in Boston, assessed the impact of cardiovascular health on life expectancy and freedom from chronic diseases. Cardiovascular health (CVH) was based on the Life’s Essential 8 (LE8) score, a composite of health metrics released by the American Heart Association in 2022. The LE8 was developed to guide research and assessment of cardiovascular health, and includes diet, physical activity, tobacco/nicotine exposure, sleep, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
In one study, Xuan Wang, MD, a postdoctoral fellow and biostatistician in the department of epidemiology at Tulane University, New Orleans, and colleagues reviewed data from 136,599 adults in the United Kingdom Biobank who were free of cardiovascular disease, diabetes, cancer, and dementia at baseline, and for whom complete LE8 data were available.
CVH was classified as poor, intermediate, and ideal, defined as LE8 scores of less than 50, 50 to 80, and 80 or higher, respectively.
The goal of the study was to examine the role of CVH based on LE8 scores on the percentage of life expectancy free of chronic diseases.
Men and women with ideal CVH averaged 5.2 years and 6.3 years more of total life expectancy at age 50 years, compared with those with poor CVH. Out of total life expectancy, the percentage of life expectancy free of chronic diseases was 75.9% and 83.4% for men and women, respectively, compared with 64.9% and 69.4%, respectively, for men and women with poor CVH.
The researchers also found that disparities in the percentage of disease-free years for both men and women were reduced in the high CVH groups.
The findings were limited by several factors including the use of only CVD, diabetes, cancer, and dementia in the definition of “disease-free life expectancy,” the researchers noted in a press release accompanying the study. Other limitations include the lack of data on e-cigarettes, and the homogeneous White study population. More research is needed in diverse populations who experience a stronger impact from negative social determinants of health, they said.
In a second study, Hao Ma, MD, and colleagues reviewed data from 23,003 adults who participated in the National Health and Nutrition Examination Survey (NHANES) between 2005 and 2018 with mortality linked to the National Death Index through Dec. 31, 2019. The goal of the second study was to examine the association between CVH based on LE8 scores and life expectancy.
Over a median follow-up of 7.8 years, deaths occurred in 772 men and 587 women, said Dr. Ma, a postdoctoral fellow and biostatistician in epidemiology at Tulane University and coauthor on Dr. Wang’s study.
The estimated life expectancies at age 50 years for men with poor, intermediate, and ideal cardiovascular health based on the LE8 were 25.5 years, 31.2 years, and 33.1 years, respectively.
For women, the corresponding life expectancies for women at age 50 with poor, intermediate, and ideal CVH were 29.5 years, 34.2 years, and 38.4 years, respectively.
Men and women had similar gains in life expectancy from adhering to a heart-healthy lifestyle as defined by the LE8 score that reduced their risk of death from cardiovascular disease (41.8% and 44.1%, respectively).
Associations of cardiovascular health and life expectancy were similar for non-Hispanic Whites and non-Hispanic Blacks, but not among people of Mexican heritage, and more research is needed in diverse populations, the researchers wrote.
The study was limited by several factors including potential changes in cardiovascular health during the follow-up period, and by the limited analysis of racial and ethnic groups to non-Hispanic white, non-Hispanic Black, and people of Mexican heritage because of small sample sizes for other racial/ethnic groups, the researchers noted in a press release accompanying the study.
The message for clinicians and their patients is that adherence to cardiovascular health as defined by the LE8 will help not only extend life, but enhance quality of life, Dr. Xang and Dr. Ma said in an interview. “If your overall CVH score is low, we might be able to focus on one element first and improve them one by one,” they said. Sedentary lifestyle and an unhealthy diet are barriers to improving LE8 metrics that can be addressed, they added.
More research is needed to examine the effects of LE8 on high-risk patients, the researchers told this news organization. “No studies have yet focused on these patients with chronic diseases. We suspect that LE8 will play a role even in these high-risk groups,” they said. Further studies should include diverse populations and evaluations of the association between CVH change and health outcomes, they added.
“Overall, we see this 7.5-year difference [in life expectancy] going from poor to high cardiovascular health,” said Donald M. Lloyd-Jones, MD, of Northwestern University, Chicago, in a video accompanying the presentation of the study findings. The impact on life expectancy is yet another reason to motivate people to improve their cardiovascular health, said Dr. Lloyd-Jones, immediate past president of the American Heart Association and lead author on the writing group for Life’s Essential 8. “The earlier we do this, the better, and the greater the gains in life expectancy we’re likely to see in the U.S. population,” he said.
People maintaining high cardiovascular health into midlife are avoiding not only cardiovascular disease, but other chronic diseases of aging, Dr. Lloyd-Jones added. These conditions are delayed until much later in the lifespan, which allows people to enjoy better quality of life for more of their remaining years, he said.
The meeting was sponsored by the American Heart Association.
Both studies were supported by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health; the Fogarty International Center; and the Tulane Research Centers of Excellence Awards. The researchers had no financial conflicts to disclose.
Adults who follow a heart-healthy lifestyle are more likely to live longer and to be free of chronic health conditions, based on data from a pair of related studies from the United States and United Kingdom involving nearly 200,000 individuals.
The studies, presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting in Boston, assessed the impact of cardiovascular health on life expectancy and freedom from chronic diseases. Cardiovascular health (CVH) was based on the Life’s Essential 8 (LE8) score, a composite of health metrics released by the American Heart Association in 2022. The LE8 was developed to guide research and assessment of cardiovascular health, and includes diet, physical activity, tobacco/nicotine exposure, sleep, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
In one study, Xuan Wang, MD, a postdoctoral fellow and biostatistician in the department of epidemiology at Tulane University, New Orleans, and colleagues reviewed data from 136,599 adults in the United Kingdom Biobank who were free of cardiovascular disease, diabetes, cancer, and dementia at baseline, and for whom complete LE8 data were available.
CVH was classified as poor, intermediate, and ideal, defined as LE8 scores of less than 50, 50 to 80, and 80 or higher, respectively.
The goal of the study was to examine the role of CVH based on LE8 scores on the percentage of life expectancy free of chronic diseases.
Men and women with ideal CVH averaged 5.2 years and 6.3 years more of total life expectancy at age 50 years, compared with those with poor CVH. Out of total life expectancy, the percentage of life expectancy free of chronic diseases was 75.9% and 83.4% for men and women, respectively, compared with 64.9% and 69.4%, respectively, for men and women with poor CVH.
The researchers also found that disparities in the percentage of disease-free years for both men and women were reduced in the high CVH groups.
The findings were limited by several factors including the use of only CVD, diabetes, cancer, and dementia in the definition of “disease-free life expectancy,” the researchers noted in a press release accompanying the study. Other limitations include the lack of data on e-cigarettes, and the homogeneous White study population. More research is needed in diverse populations who experience a stronger impact from negative social determinants of health, they said.
In a second study, Hao Ma, MD, and colleagues reviewed data from 23,003 adults who participated in the National Health and Nutrition Examination Survey (NHANES) between 2005 and 2018 with mortality linked to the National Death Index through Dec. 31, 2019. The goal of the second study was to examine the association between CVH based on LE8 scores and life expectancy.
Over a median follow-up of 7.8 years, deaths occurred in 772 men and 587 women, said Dr. Ma, a postdoctoral fellow and biostatistician in epidemiology at Tulane University and coauthor on Dr. Wang’s study.
The estimated life expectancies at age 50 years for men with poor, intermediate, and ideal cardiovascular health based on the LE8 were 25.5 years, 31.2 years, and 33.1 years, respectively.
For women, the corresponding life expectancies for women at age 50 with poor, intermediate, and ideal CVH were 29.5 years, 34.2 years, and 38.4 years, respectively.
Men and women had similar gains in life expectancy from adhering to a heart-healthy lifestyle as defined by the LE8 score that reduced their risk of death from cardiovascular disease (41.8% and 44.1%, respectively).
Associations of cardiovascular health and life expectancy were similar for non-Hispanic Whites and non-Hispanic Blacks, but not among people of Mexican heritage, and more research is needed in diverse populations, the researchers wrote.
The study was limited by several factors including potential changes in cardiovascular health during the follow-up period, and by the limited analysis of racial and ethnic groups to non-Hispanic white, non-Hispanic Black, and people of Mexican heritage because of small sample sizes for other racial/ethnic groups, the researchers noted in a press release accompanying the study.
The message for clinicians and their patients is that adherence to cardiovascular health as defined by the LE8 will help not only extend life, but enhance quality of life, Dr. Xang and Dr. Ma said in an interview. “If your overall CVH score is low, we might be able to focus on one element first and improve them one by one,” they said. Sedentary lifestyle and an unhealthy diet are barriers to improving LE8 metrics that can be addressed, they added.
More research is needed to examine the effects of LE8 on high-risk patients, the researchers told this news organization. “No studies have yet focused on these patients with chronic diseases. We suspect that LE8 will play a role even in these high-risk groups,” they said. Further studies should include diverse populations and evaluations of the association between CVH change and health outcomes, they added.
“Overall, we see this 7.5-year difference [in life expectancy] going from poor to high cardiovascular health,” said Donald M. Lloyd-Jones, MD, of Northwestern University, Chicago, in a video accompanying the presentation of the study findings. The impact on life expectancy is yet another reason to motivate people to improve their cardiovascular health, said Dr. Lloyd-Jones, immediate past president of the American Heart Association and lead author on the writing group for Life’s Essential 8. “The earlier we do this, the better, and the greater the gains in life expectancy we’re likely to see in the U.S. population,” he said.
People maintaining high cardiovascular health into midlife are avoiding not only cardiovascular disease, but other chronic diseases of aging, Dr. Lloyd-Jones added. These conditions are delayed until much later in the lifespan, which allows people to enjoy better quality of life for more of their remaining years, he said.
The meeting was sponsored by the American Heart Association.
Both studies were supported by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health; the Fogarty International Center; and the Tulane Research Centers of Excellence Awards. The researchers had no financial conflicts to disclose.
FROM EPI/LIFESTYLE 2023
Pulmonary function may predict frailty
Pulmonary function was significantly associated with frailty in community-dwelling older adults over a 5-year period, as indicated by data from more than 1,000 individuals.
The pulmonary function test has been proposed as a predictive tool for clinical outcomes in geriatrics, including hospitalization, mortality, and frailty, but , write Walter Sepulveda-Loyola, MD, of Universidad de Las Americas, Santiago, Chile, and colleagues.
In an observational study published in Heart and Lung, the researchers reviewed data from adults older than 64 years who were participants in the Toledo Study for Healthy Aging.
The study population included 1,188 older adults (mean age, 74 years; 54% women). The prevalence of frailty at baseline ranged from 7% to 26%.
Frailty was defined using the frailty phenotype (FP) and the Frailty Trait Scale 5 (FTS5). Pulmonary function was determined on the basis of forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC), using spirometry.
Overall, at the 5-year follow-up, FEV1 and FVC were inversely associated with prevalence and incidence of frailty in nonadjusted and adjusted models using FP and FTS5.
In adjusted models, FEV1 and FVC, as well as FEV1 and FVC percent predicted value, were significantly associated with the prevalence of frailty, with odds ratios ranging from 0.53 to 0.99. FEV1 and FVC were significantly associated with increased incidence of frailty, with odds ratios ranging from 0.49 to 0.50 (P < .05 for both).
Pulmonary function also was associated with prevalent and incident frailty, hospitalization, and mortality in regression models, including the whole sample and after respiratory diseases were excluded.
Pulmonary function measures below the cutoff points for FEV1 and FVC were significantly associated with frailty, as well as with hospitalization and mortality. The cutoff points for FEV1 were 1.805 L for men and 1.165 L for women; cutoff points for FVC were 2.385 L for men and 1.585 L for women.
“Pulmonary function should be evaluated not only in frail patients, with the aim of detecting patients with poor prognoses regardless of their comorbidity, but also in individuals who are not frail but have an increased risk of developing frailty, as well as other adverse events,” the researchers write.
The study findings were limited by lack of data on pulmonary function variables outside of spirometry and by the need for data from populations with different characteristics to assess whether the same cutoff points are predictive of frailty, the researchers note.
The results were strengthened by the large sample size and additional analysis that excluded other respiratory diseases. Future research should consider adding pulmonary function assessment to the frailty model, the authors write.
Given the relationship between pulmonary function and physical capacity, the current study supports more frequent evaluation of pulmonary function in clinical practice for older adults, including those with no pulmonary disease, they conclude.
The study was supported by the Spanish Ministry of Economy, Industry, and Competitiveness, financed by the European Regional Development Funds, and the Centro de Investigacion Biomedica en Red en Fragilidad y Envejecimiento Saludable and the Fundacion Francisco Soria Melguizo. Lead author Dr. Sepulveda-Loyola was supported by the Brazilian National Council for Scientific and Technological Development.
A version of this article first appeared on Medscape.com.
Pulmonary function was significantly associated with frailty in community-dwelling older adults over a 5-year period, as indicated by data from more than 1,000 individuals.
The pulmonary function test has been proposed as a predictive tool for clinical outcomes in geriatrics, including hospitalization, mortality, and frailty, but , write Walter Sepulveda-Loyola, MD, of Universidad de Las Americas, Santiago, Chile, and colleagues.
In an observational study published in Heart and Lung, the researchers reviewed data from adults older than 64 years who were participants in the Toledo Study for Healthy Aging.
The study population included 1,188 older adults (mean age, 74 years; 54% women). The prevalence of frailty at baseline ranged from 7% to 26%.
Frailty was defined using the frailty phenotype (FP) and the Frailty Trait Scale 5 (FTS5). Pulmonary function was determined on the basis of forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC), using spirometry.
Overall, at the 5-year follow-up, FEV1 and FVC were inversely associated with prevalence and incidence of frailty in nonadjusted and adjusted models using FP and FTS5.
In adjusted models, FEV1 and FVC, as well as FEV1 and FVC percent predicted value, were significantly associated with the prevalence of frailty, with odds ratios ranging from 0.53 to 0.99. FEV1 and FVC were significantly associated with increased incidence of frailty, with odds ratios ranging from 0.49 to 0.50 (P < .05 for both).
Pulmonary function also was associated with prevalent and incident frailty, hospitalization, and mortality in regression models, including the whole sample and after respiratory diseases were excluded.
Pulmonary function measures below the cutoff points for FEV1 and FVC were significantly associated with frailty, as well as with hospitalization and mortality. The cutoff points for FEV1 were 1.805 L for men and 1.165 L for women; cutoff points for FVC were 2.385 L for men and 1.585 L for women.
“Pulmonary function should be evaluated not only in frail patients, with the aim of detecting patients with poor prognoses regardless of their comorbidity, but also in individuals who are not frail but have an increased risk of developing frailty, as well as other adverse events,” the researchers write.
The study findings were limited by lack of data on pulmonary function variables outside of spirometry and by the need for data from populations with different characteristics to assess whether the same cutoff points are predictive of frailty, the researchers note.
The results were strengthened by the large sample size and additional analysis that excluded other respiratory diseases. Future research should consider adding pulmonary function assessment to the frailty model, the authors write.
Given the relationship between pulmonary function and physical capacity, the current study supports more frequent evaluation of pulmonary function in clinical practice for older adults, including those with no pulmonary disease, they conclude.
The study was supported by the Spanish Ministry of Economy, Industry, and Competitiveness, financed by the European Regional Development Funds, and the Centro de Investigacion Biomedica en Red en Fragilidad y Envejecimiento Saludable and the Fundacion Francisco Soria Melguizo. Lead author Dr. Sepulveda-Loyola was supported by the Brazilian National Council for Scientific and Technological Development.
A version of this article first appeared on Medscape.com.
Pulmonary function was significantly associated with frailty in community-dwelling older adults over a 5-year period, as indicated by data from more than 1,000 individuals.
The pulmonary function test has been proposed as a predictive tool for clinical outcomes in geriatrics, including hospitalization, mortality, and frailty, but , write Walter Sepulveda-Loyola, MD, of Universidad de Las Americas, Santiago, Chile, and colleagues.
In an observational study published in Heart and Lung, the researchers reviewed data from adults older than 64 years who were participants in the Toledo Study for Healthy Aging.
The study population included 1,188 older adults (mean age, 74 years; 54% women). The prevalence of frailty at baseline ranged from 7% to 26%.
Frailty was defined using the frailty phenotype (FP) and the Frailty Trait Scale 5 (FTS5). Pulmonary function was determined on the basis of forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC), using spirometry.
Overall, at the 5-year follow-up, FEV1 and FVC were inversely associated with prevalence and incidence of frailty in nonadjusted and adjusted models using FP and FTS5.
In adjusted models, FEV1 and FVC, as well as FEV1 and FVC percent predicted value, were significantly associated with the prevalence of frailty, with odds ratios ranging from 0.53 to 0.99. FEV1 and FVC were significantly associated with increased incidence of frailty, with odds ratios ranging from 0.49 to 0.50 (P < .05 for both).
Pulmonary function also was associated with prevalent and incident frailty, hospitalization, and mortality in regression models, including the whole sample and after respiratory diseases were excluded.
Pulmonary function measures below the cutoff points for FEV1 and FVC were significantly associated with frailty, as well as with hospitalization and mortality. The cutoff points for FEV1 were 1.805 L for men and 1.165 L for women; cutoff points for FVC were 2.385 L for men and 1.585 L for women.
“Pulmonary function should be evaluated not only in frail patients, with the aim of detecting patients with poor prognoses regardless of their comorbidity, but also in individuals who are not frail but have an increased risk of developing frailty, as well as other adverse events,” the researchers write.
The study findings were limited by lack of data on pulmonary function variables outside of spirometry and by the need for data from populations with different characteristics to assess whether the same cutoff points are predictive of frailty, the researchers note.
The results were strengthened by the large sample size and additional analysis that excluded other respiratory diseases. Future research should consider adding pulmonary function assessment to the frailty model, the authors write.
Given the relationship between pulmonary function and physical capacity, the current study supports more frequent evaluation of pulmonary function in clinical practice for older adults, including those with no pulmonary disease, they conclude.
The study was supported by the Spanish Ministry of Economy, Industry, and Competitiveness, financed by the European Regional Development Funds, and the Centro de Investigacion Biomedica en Red en Fragilidad y Envejecimiento Saludable and the Fundacion Francisco Soria Melguizo. Lead author Dr. Sepulveda-Loyola was supported by the Brazilian National Council for Scientific and Technological Development.
A version of this article first appeared on Medscape.com.
FDA accepts application for topical molluscum treatment
If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.
Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.
The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.
The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.
The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.
If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.
Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.
The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.
The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.
The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.
If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.
Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.
The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.
The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.
The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.
Thyroid hormones predict psychotic depression in MDD patients
Thyroid dysfunction is common among major depressive disorder (MDD) patients, but its relationship with the psychotic depression (PD) subtype has not been well studied, wrote Pu Peng, of The Second Xiangya Hospital of Central South University, Changsha, Hunan, China, and colleagues.
Given the significant negative consequences of PD in MDD, including comorbid psychosis, suicidal attempts, and worse prognosis, more ways to identify PD risk factors in MDD are needed, they said. Previous research suggests a role for thyroid hormones in the pathophysiology of PD, but data on specific associations are limited, they noted.
In a study published in Psychiatry Research, the authors recruited 1,718 adults aged 18-60 years with MDD who were treated at a single center. The median age was 34 years, 66% were female, and 10% were identified with PD.
Clinical symptoms were identified using the positive subscale of the Positive and Negative Symptom Scale (PANSS-P), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). The median PANSS-P score was 7. The researchers measured serum levels of thyroid stimulating hormone (TSH), anti-thyroglobulin (TgAb), and thyroid peroxidases antibody (TPOAb). Subclinical hyperthyroidism (SCH) was defined as TSH levels greater than 8.0 uIU/L and FT4 within normal values.
Overall, the prevalence of SCH, abnormal TgAb, TPOAb, FT3, and FT4 were 13%, 17%, 25%, <0.1%, and 0.3%, respectively. Serum TSH levels, TgAb levels, and TPOAb levels were significantly higher in PD patients than in non-PD patients. No differences appeared in FT3 and FT4 levels between the two groups.
In a multivariate analysis, subclinical hypothyroidism was associated with a ninefold increased risk of PD (odds ratio, 9.32) as were abnormal TPOAb (OR, 1.89) and abnormal TgAb (OR, 2.09).
The findings were limited by several factors including the cross-sectional design, and the inclusion of participants from only a single center in China, which may limit generalizability, the researchers noted.
In addition, “It should be noted that the association between thyroid hormones and PD was small to moderate and the underlying mechanism remained unexplored,” they said. Other limitations include the use of only 17 of the 20 HAMD items and the lack of data on the relationship between anxiety and depressive features and thyroid dysfunction, they wrote.
More research is needed to confirm the findings in other populations, however; the results suggest that regular thyroid function tests may help with early detection of PD in MDD patients, they concluded.
The study was funded by the CAS Pioneer Hundred Talents Program and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Thyroid dysfunction is common among major depressive disorder (MDD) patients, but its relationship with the psychotic depression (PD) subtype has not been well studied, wrote Pu Peng, of The Second Xiangya Hospital of Central South University, Changsha, Hunan, China, and colleagues.
Given the significant negative consequences of PD in MDD, including comorbid psychosis, suicidal attempts, and worse prognosis, more ways to identify PD risk factors in MDD are needed, they said. Previous research suggests a role for thyroid hormones in the pathophysiology of PD, but data on specific associations are limited, they noted.
In a study published in Psychiatry Research, the authors recruited 1,718 adults aged 18-60 years with MDD who were treated at a single center. The median age was 34 years, 66% were female, and 10% were identified with PD.
Clinical symptoms were identified using the positive subscale of the Positive and Negative Symptom Scale (PANSS-P), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). The median PANSS-P score was 7. The researchers measured serum levels of thyroid stimulating hormone (TSH), anti-thyroglobulin (TgAb), and thyroid peroxidases antibody (TPOAb). Subclinical hyperthyroidism (SCH) was defined as TSH levels greater than 8.0 uIU/L and FT4 within normal values.
Overall, the prevalence of SCH, abnormal TgAb, TPOAb, FT3, and FT4 were 13%, 17%, 25%, <0.1%, and 0.3%, respectively. Serum TSH levels, TgAb levels, and TPOAb levels were significantly higher in PD patients than in non-PD patients. No differences appeared in FT3 and FT4 levels between the two groups.
In a multivariate analysis, subclinical hypothyroidism was associated with a ninefold increased risk of PD (odds ratio, 9.32) as were abnormal TPOAb (OR, 1.89) and abnormal TgAb (OR, 2.09).
The findings were limited by several factors including the cross-sectional design, and the inclusion of participants from only a single center in China, which may limit generalizability, the researchers noted.
In addition, “It should be noted that the association between thyroid hormones and PD was small to moderate and the underlying mechanism remained unexplored,” they said. Other limitations include the use of only 17 of the 20 HAMD items and the lack of data on the relationship between anxiety and depressive features and thyroid dysfunction, they wrote.
More research is needed to confirm the findings in other populations, however; the results suggest that regular thyroid function tests may help with early detection of PD in MDD patients, they concluded.
The study was funded by the CAS Pioneer Hundred Talents Program and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Thyroid dysfunction is common among major depressive disorder (MDD) patients, but its relationship with the psychotic depression (PD) subtype has not been well studied, wrote Pu Peng, of The Second Xiangya Hospital of Central South University, Changsha, Hunan, China, and colleagues.
Given the significant negative consequences of PD in MDD, including comorbid psychosis, suicidal attempts, and worse prognosis, more ways to identify PD risk factors in MDD are needed, they said. Previous research suggests a role for thyroid hormones in the pathophysiology of PD, but data on specific associations are limited, they noted.
In a study published in Psychiatry Research, the authors recruited 1,718 adults aged 18-60 years with MDD who were treated at a single center. The median age was 34 years, 66% were female, and 10% were identified with PD.
Clinical symptoms were identified using the positive subscale of the Positive and Negative Symptom Scale (PANSS-P), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). The median PANSS-P score was 7. The researchers measured serum levels of thyroid stimulating hormone (TSH), anti-thyroglobulin (TgAb), and thyroid peroxidases antibody (TPOAb). Subclinical hyperthyroidism (SCH) was defined as TSH levels greater than 8.0 uIU/L and FT4 within normal values.
Overall, the prevalence of SCH, abnormal TgAb, TPOAb, FT3, and FT4 were 13%, 17%, 25%, <0.1%, and 0.3%, respectively. Serum TSH levels, TgAb levels, and TPOAb levels were significantly higher in PD patients than in non-PD patients. No differences appeared in FT3 and FT4 levels between the two groups.
In a multivariate analysis, subclinical hypothyroidism was associated with a ninefold increased risk of PD (odds ratio, 9.32) as were abnormal TPOAb (OR, 1.89) and abnormal TgAb (OR, 2.09).
The findings were limited by several factors including the cross-sectional design, and the inclusion of participants from only a single center in China, which may limit generalizability, the researchers noted.
In addition, “It should be noted that the association between thyroid hormones and PD was small to moderate and the underlying mechanism remained unexplored,” they said. Other limitations include the use of only 17 of the 20 HAMD items and the lack of data on the relationship between anxiety and depressive features and thyroid dysfunction, they wrote.
More research is needed to confirm the findings in other populations, however; the results suggest that regular thyroid function tests may help with early detection of PD in MDD patients, they concluded.
The study was funded by the CAS Pioneer Hundred Talents Program and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
FROM PSYCHIATRY RESEARCH
Which nonopioid meds are best for easing acute low back pain?
based on data from more than 3,000 individuals.
Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.
In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.
The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.
Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.
In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.
Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.
However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.
The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.
More research is needed to address the effects of different drugs on LBP recurrence, they add.
However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.
The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.
Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”
A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.
Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.
The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
based on data from more than 3,000 individuals.
Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.
In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.
The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.
Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.
In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.
Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.
However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.
The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.
More research is needed to address the effects of different drugs on LBP recurrence, they add.
However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.
The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.
Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”
A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.
Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.
The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
based on data from more than 3,000 individuals.
Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.
In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.
The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.
Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.
In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.
Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.
However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.
The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.
More research is needed to address the effects of different drugs on LBP recurrence, they add.
However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.
The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.
Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”
A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.
Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.
The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ORTHOPAEDIC RESEARCH
500 more steps a day tied to 14% lower CVD risk in older adults
Older adults who added a quarter mile of steps to their day showed a reduction in risk of cardiovascular events by 14% within 4 years, according to a study in more than 400 individuals.
“Aging is such a dynamic process, but most studies of daily steps and step goals are conducted on younger populations,” lead author Erin E. Dooley, PhD, an epidemiologist at the University of Alabama at Birmingham, said in an interview.
The impact of more modest step goals in older adults has not been well studied, Dr. Dooley said.
The population in the current study ranged from 71 to 92 years, with an average age of 78 years. The older age and relatively short follow-up period show the importance of steps and physical activity in older adults, she said.
Dr. Dooley presented the study at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
She and her colleagues analyzed a subsample of participants in Atherosclerosis Risk in Communities (ARIC) study, an ongoing study conducted by the National Heart, Lung, and Blood Institute. The study population included 452 adults for whom step data were available at visit 6 of the ARIC study between 2016 and 2017. Participants wore an accelerometer on the waist for at least 10 hours a day for at least 3 days. The mean age of the participants was 78.4 years, 59% were women, and 20% were Black.
Outcomes were measured through December 2019 and included fatal and nonfatal cardiovascular disease (CVD) events of coronary heart disease, stroke, and heart failure.
Overall, each additional 500 steps per day was linked to a 14% reduction in risk of a CVD event (hazard ratio, 0.86; 95% confidence interval, 0.76-0.98). The mean step count was 3,447 steps per day, and 34 participants (7.5%) experienced a CVD event over 1,269 person-years of follow-up.
The cumulative risk of CVD was significantly higher (11.5%) in the quartile of adults with the lowest step count (defined as fewer than 2,077 steps per day), compared with 3.5% in those with the highest step count (defined as at least 4,453 steps per day).
In addition, adults in the highest quartile of steps had a 77% reduced risk of a proximal CVD (within 3.5 years) event over the study period (HR, 0.23).
Additional research is needed to explore whether increased steps prevent or delay CVD and whether low step counts may be a biomarker for underlying disease, the researchers noted in their abstract.
However, the results support the value of even a modest increase in activity to reduce CVD risk in older adults.
Small steps may get patients started
Dr. Dooley said she was surprised at the degree of benefits on heart health from 500 steps, and noted that the findings have clinical implications.
“Steps may be a more understandable metric for physical activity for patients than talking about moderate to vigorous intensity physical activity,” she said in an interview. “While we do not want to diminish the importance of higher intensity physical activity, encouraging small increases in the number of daily steps can also have great benefits for heart health.
“Steps are counted using a variety of devices and phones, so it may be helpful for patients to show clinicians their activity during well visits,” Dr. Dooley said. “Walking may also be more manageable for people as it is low impact. Achievable goals are also important. This study suggests that, for older adults, around 3,000 steps or more was associated with reduced CVD risk,” although the greatest benefits were seen with the most active group who averaged 4,500 or more steps per day.
More research is needed to show how steps may change over time, and how this relates to CVD and heart health,” she said. “At this time, we only had a single measure of physical activity.”
Study fills research gap for older adults
“Currently, the majority of the literature exploring a relationship between physical activity and the risk for developing cardiovascular disease has evaluated all adults together, not only those who are 70 year of age and older,” Monica C. Serra, PhD, of the University of Texas, San Antonio, said in an interview. “This study allows us to start to target specific cardiovascular recommendations for older adults.”.
“It is always exciting to see results from physical activity studies that continue to support prior evidence that even small amounts of physical activity are beneficial to cardiovascular health,” said Dr. Serra, who is also vice chair of the program committee for the meeting. “These results suggest that even if only small additions in physical activity are achievable, they may have cumulative benefits in reducing cardiovascular disease risk.” For clinicians, the results also provide targets that are easy for patients to understand, said Dr. Serra. Daily step counts allow clinicians to provide specific and measurable goals to help their older patients increase physical activity.
“Small additions in total daily step counts may have clinically meaningful benefits to heart health, so promoting their patients to make any slight changes that are able to be consistently incorporated into their schedule should be encouraged. This may be best monitored by encouraging the use of an activity tracker,” she said.
Although the current study adds to the literature with objective measures of physical activity utilizing accelerometers, these devices are not as sensitive at picking up activities such as bicycling or swimming, which may be more appropriate for some older adults with mobility limitations and chronic conditions, Dr. Serra said. Additional research is needed to assess the impact of other activities on CVD in the older population.
The meeting was sponsored by the American Heart Association. The study received no outside funding. Dr. Dooley and Dr. Serra had no financial conflicts to disclose.
Older adults who added a quarter mile of steps to their day showed a reduction in risk of cardiovascular events by 14% within 4 years, according to a study in more than 400 individuals.
“Aging is such a dynamic process, but most studies of daily steps and step goals are conducted on younger populations,” lead author Erin E. Dooley, PhD, an epidemiologist at the University of Alabama at Birmingham, said in an interview.
The impact of more modest step goals in older adults has not been well studied, Dr. Dooley said.
The population in the current study ranged from 71 to 92 years, with an average age of 78 years. The older age and relatively short follow-up period show the importance of steps and physical activity in older adults, she said.
Dr. Dooley presented the study at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
She and her colleagues analyzed a subsample of participants in Atherosclerosis Risk in Communities (ARIC) study, an ongoing study conducted by the National Heart, Lung, and Blood Institute. The study population included 452 adults for whom step data were available at visit 6 of the ARIC study between 2016 and 2017. Participants wore an accelerometer on the waist for at least 10 hours a day for at least 3 days. The mean age of the participants was 78.4 years, 59% were women, and 20% were Black.
Outcomes were measured through December 2019 and included fatal and nonfatal cardiovascular disease (CVD) events of coronary heart disease, stroke, and heart failure.
Overall, each additional 500 steps per day was linked to a 14% reduction in risk of a CVD event (hazard ratio, 0.86; 95% confidence interval, 0.76-0.98). The mean step count was 3,447 steps per day, and 34 participants (7.5%) experienced a CVD event over 1,269 person-years of follow-up.
The cumulative risk of CVD was significantly higher (11.5%) in the quartile of adults with the lowest step count (defined as fewer than 2,077 steps per day), compared with 3.5% in those with the highest step count (defined as at least 4,453 steps per day).
In addition, adults in the highest quartile of steps had a 77% reduced risk of a proximal CVD (within 3.5 years) event over the study period (HR, 0.23).
Additional research is needed to explore whether increased steps prevent or delay CVD and whether low step counts may be a biomarker for underlying disease, the researchers noted in their abstract.
However, the results support the value of even a modest increase in activity to reduce CVD risk in older adults.
Small steps may get patients started
Dr. Dooley said she was surprised at the degree of benefits on heart health from 500 steps, and noted that the findings have clinical implications.
“Steps may be a more understandable metric for physical activity for patients than talking about moderate to vigorous intensity physical activity,” she said in an interview. “While we do not want to diminish the importance of higher intensity physical activity, encouraging small increases in the number of daily steps can also have great benefits for heart health.
“Steps are counted using a variety of devices and phones, so it may be helpful for patients to show clinicians their activity during well visits,” Dr. Dooley said. “Walking may also be more manageable for people as it is low impact. Achievable goals are also important. This study suggests that, for older adults, around 3,000 steps or more was associated with reduced CVD risk,” although the greatest benefits were seen with the most active group who averaged 4,500 or more steps per day.
More research is needed to show how steps may change over time, and how this relates to CVD and heart health,” she said. “At this time, we only had a single measure of physical activity.”
Study fills research gap for older adults
“Currently, the majority of the literature exploring a relationship between physical activity and the risk for developing cardiovascular disease has evaluated all adults together, not only those who are 70 year of age and older,” Monica C. Serra, PhD, of the University of Texas, San Antonio, said in an interview. “This study allows us to start to target specific cardiovascular recommendations for older adults.”.
“It is always exciting to see results from physical activity studies that continue to support prior evidence that even small amounts of physical activity are beneficial to cardiovascular health,” said Dr. Serra, who is also vice chair of the program committee for the meeting. “These results suggest that even if only small additions in physical activity are achievable, they may have cumulative benefits in reducing cardiovascular disease risk.” For clinicians, the results also provide targets that are easy for patients to understand, said Dr. Serra. Daily step counts allow clinicians to provide specific and measurable goals to help their older patients increase physical activity.
“Small additions in total daily step counts may have clinically meaningful benefits to heart health, so promoting their patients to make any slight changes that are able to be consistently incorporated into their schedule should be encouraged. This may be best monitored by encouraging the use of an activity tracker,” she said.
Although the current study adds to the literature with objective measures of physical activity utilizing accelerometers, these devices are not as sensitive at picking up activities such as bicycling or swimming, which may be more appropriate for some older adults with mobility limitations and chronic conditions, Dr. Serra said. Additional research is needed to assess the impact of other activities on CVD in the older population.
The meeting was sponsored by the American Heart Association. The study received no outside funding. Dr. Dooley and Dr. Serra had no financial conflicts to disclose.
Older adults who added a quarter mile of steps to their day showed a reduction in risk of cardiovascular events by 14% within 4 years, according to a study in more than 400 individuals.
“Aging is such a dynamic process, but most studies of daily steps and step goals are conducted on younger populations,” lead author Erin E. Dooley, PhD, an epidemiologist at the University of Alabama at Birmingham, said in an interview.
The impact of more modest step goals in older adults has not been well studied, Dr. Dooley said.
The population in the current study ranged from 71 to 92 years, with an average age of 78 years. The older age and relatively short follow-up period show the importance of steps and physical activity in older adults, she said.
Dr. Dooley presented the study at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting.
She and her colleagues analyzed a subsample of participants in Atherosclerosis Risk in Communities (ARIC) study, an ongoing study conducted by the National Heart, Lung, and Blood Institute. The study population included 452 adults for whom step data were available at visit 6 of the ARIC study between 2016 and 2017. Participants wore an accelerometer on the waist for at least 10 hours a day for at least 3 days. The mean age of the participants was 78.4 years, 59% were women, and 20% were Black.
Outcomes were measured through December 2019 and included fatal and nonfatal cardiovascular disease (CVD) events of coronary heart disease, stroke, and heart failure.
Overall, each additional 500 steps per day was linked to a 14% reduction in risk of a CVD event (hazard ratio, 0.86; 95% confidence interval, 0.76-0.98). The mean step count was 3,447 steps per day, and 34 participants (7.5%) experienced a CVD event over 1,269 person-years of follow-up.
The cumulative risk of CVD was significantly higher (11.5%) in the quartile of adults with the lowest step count (defined as fewer than 2,077 steps per day), compared with 3.5% in those with the highest step count (defined as at least 4,453 steps per day).
In addition, adults in the highest quartile of steps had a 77% reduced risk of a proximal CVD (within 3.5 years) event over the study period (HR, 0.23).
Additional research is needed to explore whether increased steps prevent or delay CVD and whether low step counts may be a biomarker for underlying disease, the researchers noted in their abstract.
However, the results support the value of even a modest increase in activity to reduce CVD risk in older adults.
Small steps may get patients started
Dr. Dooley said she was surprised at the degree of benefits on heart health from 500 steps, and noted that the findings have clinical implications.
“Steps may be a more understandable metric for physical activity for patients than talking about moderate to vigorous intensity physical activity,” she said in an interview. “While we do not want to diminish the importance of higher intensity physical activity, encouraging small increases in the number of daily steps can also have great benefits for heart health.
“Steps are counted using a variety of devices and phones, so it may be helpful for patients to show clinicians their activity during well visits,” Dr. Dooley said. “Walking may also be more manageable for people as it is low impact. Achievable goals are also important. This study suggests that, for older adults, around 3,000 steps or more was associated with reduced CVD risk,” although the greatest benefits were seen with the most active group who averaged 4,500 or more steps per day.
More research is needed to show how steps may change over time, and how this relates to CVD and heart health,” she said. “At this time, we only had a single measure of physical activity.”
Study fills research gap for older adults
“Currently, the majority of the literature exploring a relationship between physical activity and the risk for developing cardiovascular disease has evaluated all adults together, not only those who are 70 year of age and older,” Monica C. Serra, PhD, of the University of Texas, San Antonio, said in an interview. “This study allows us to start to target specific cardiovascular recommendations for older adults.”.
“It is always exciting to see results from physical activity studies that continue to support prior evidence that even small amounts of physical activity are beneficial to cardiovascular health,” said Dr. Serra, who is also vice chair of the program committee for the meeting. “These results suggest that even if only small additions in physical activity are achievable, they may have cumulative benefits in reducing cardiovascular disease risk.” For clinicians, the results also provide targets that are easy for patients to understand, said Dr. Serra. Daily step counts allow clinicians to provide specific and measurable goals to help their older patients increase physical activity.
“Small additions in total daily step counts may have clinically meaningful benefits to heart health, so promoting their patients to make any slight changes that are able to be consistently incorporated into their schedule should be encouraged. This may be best monitored by encouraging the use of an activity tracker,” she said.
Although the current study adds to the literature with objective measures of physical activity utilizing accelerometers, these devices are not as sensitive at picking up activities such as bicycling or swimming, which may be more appropriate for some older adults with mobility limitations and chronic conditions, Dr. Serra said. Additional research is needed to assess the impact of other activities on CVD in the older population.
The meeting was sponsored by the American Heart Association. The study received no outside funding. Dr. Dooley and Dr. Serra had no financial conflicts to disclose.
FROM EPI/LIFESTYLE 2023
Sputum markers may predict remission in eosinophilic asthma
for patients with severe eosinophilic asthma. The finding was based on data from 52 individuals.
Although IL-5 therapies have been shown to be effective for improving asthma, patients’ responses vary, write Catherine Moermans, PhD, of Liège University, Belgium, and colleagues.
Biotherapies targeting IL-5 allow a tangible improvement of asthma. However, all patients do not respond the same way to these treatments, and reliable biomarkers for predicting treatment response are lacking, they say.
In an observational study published in the journal Chest, the researchers recruited 52 adults with severe asthma who began anti–IL-5 treatment at a single center. The primary outcome was remission of asthma.
Remission was defined as meeting all of the following criteria 1 year after therapy: no chronic treatment with oral corticosteroids; no exacerbation; asthma control questionnaire scores lower than 1.5 and/or asthma test greater than 19; forced expiratory volume in 1 second (FEV1) of at least 80% predicted; and/or improvement of FEV1 equal to or larger than 10%, and a blood eosinophil count lower than 300 cells/mL.
Prior to treatment, the researchers measured eosinophil peroxidase (EPX), immunoglobulin E (IgE), IL-3, IL-4, IL-5, IL-13, IL-25, IL-33, granulocyte-macrophage colony-stimulating factor (GM-CSF), thymic stromal lymphopoietin (TSLP), and eotaxin-1 levels in the sputum of each patient.
At follow-up, 11 patients met the criteria for remission. These patients had significantly higher sputum eosinophil counts, sputum macrophage counts, and lymphocyte counts at baseline, compared with those not in remission (P = .006, P = .02, and P = .04, respectively). Sputum neutrophil percentage levels were significantly lower in patients whose asthma was in remission, compared with those whose asthma was not in remission (P = .007).
At the protein level, remission patients also showed higher baseline levels of sputum eotaxin-1, TSLP, IL-5, EPX, and IgE protein, compared with patients who did not achieve remission (P = .046, P = .04, P = .002, P = .001, and P = .006, respectively).
Overall, EPX and IL-5 measures showed the best combination of sensitivity and specificity, as well as the best area under the curve, the researchers write.
Patients in remission were significantly more likely to be men (8 of 11 patients), a finding that reflected previous studies, the researchers write. The finding of eosinophilic inflammation associated with stronger response to anti–IL-5 therapy also reflected previous studies, but the current study showed that “with a comparable blood eosinophil level at baseline before biotherapy, the response can be highly variable.”
The study findings were limited by several factors, including the small sample size and the lack of a formal definition of remission. Other research needs include an analysis based on nonresponse or suboptimal response predictors, the researchers note.
The results suggest that sputum type 2 markers are potential predictors of remission after anti–IL-5 treatment in adults with severe eosinophilic asthma, although the results must be validated in a larger, multicenter cohort, they conclude.
The study was supported by GlaxoSmithKline and AstraZeneca. Several coauthors have relationships with these companies. Dr. Moermans has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
for patients with severe eosinophilic asthma. The finding was based on data from 52 individuals.
Although IL-5 therapies have been shown to be effective for improving asthma, patients’ responses vary, write Catherine Moermans, PhD, of Liège University, Belgium, and colleagues.
Biotherapies targeting IL-5 allow a tangible improvement of asthma. However, all patients do not respond the same way to these treatments, and reliable biomarkers for predicting treatment response are lacking, they say.
In an observational study published in the journal Chest, the researchers recruited 52 adults with severe asthma who began anti–IL-5 treatment at a single center. The primary outcome was remission of asthma.
Remission was defined as meeting all of the following criteria 1 year after therapy: no chronic treatment with oral corticosteroids; no exacerbation; asthma control questionnaire scores lower than 1.5 and/or asthma test greater than 19; forced expiratory volume in 1 second (FEV1) of at least 80% predicted; and/or improvement of FEV1 equal to or larger than 10%, and a blood eosinophil count lower than 300 cells/mL.
Prior to treatment, the researchers measured eosinophil peroxidase (EPX), immunoglobulin E (IgE), IL-3, IL-4, IL-5, IL-13, IL-25, IL-33, granulocyte-macrophage colony-stimulating factor (GM-CSF), thymic stromal lymphopoietin (TSLP), and eotaxin-1 levels in the sputum of each patient.
At follow-up, 11 patients met the criteria for remission. These patients had significantly higher sputum eosinophil counts, sputum macrophage counts, and lymphocyte counts at baseline, compared with those not in remission (P = .006, P = .02, and P = .04, respectively). Sputum neutrophil percentage levels were significantly lower in patients whose asthma was in remission, compared with those whose asthma was not in remission (P = .007).
At the protein level, remission patients also showed higher baseline levels of sputum eotaxin-1, TSLP, IL-5, EPX, and IgE protein, compared with patients who did not achieve remission (P = .046, P = .04, P = .002, P = .001, and P = .006, respectively).
Overall, EPX and IL-5 measures showed the best combination of sensitivity and specificity, as well as the best area under the curve, the researchers write.
Patients in remission were significantly more likely to be men (8 of 11 patients), a finding that reflected previous studies, the researchers write. The finding of eosinophilic inflammation associated with stronger response to anti–IL-5 therapy also reflected previous studies, but the current study showed that “with a comparable blood eosinophil level at baseline before biotherapy, the response can be highly variable.”
The study findings were limited by several factors, including the small sample size and the lack of a formal definition of remission. Other research needs include an analysis based on nonresponse or suboptimal response predictors, the researchers note.
The results suggest that sputum type 2 markers are potential predictors of remission after anti–IL-5 treatment in adults with severe eosinophilic asthma, although the results must be validated in a larger, multicenter cohort, they conclude.
The study was supported by GlaxoSmithKline and AstraZeneca. Several coauthors have relationships with these companies. Dr. Moermans has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
for patients with severe eosinophilic asthma. The finding was based on data from 52 individuals.
Although IL-5 therapies have been shown to be effective for improving asthma, patients’ responses vary, write Catherine Moermans, PhD, of Liège University, Belgium, and colleagues.
Biotherapies targeting IL-5 allow a tangible improvement of asthma. However, all patients do not respond the same way to these treatments, and reliable biomarkers for predicting treatment response are lacking, they say.
In an observational study published in the journal Chest, the researchers recruited 52 adults with severe asthma who began anti–IL-5 treatment at a single center. The primary outcome was remission of asthma.
Remission was defined as meeting all of the following criteria 1 year after therapy: no chronic treatment with oral corticosteroids; no exacerbation; asthma control questionnaire scores lower than 1.5 and/or asthma test greater than 19; forced expiratory volume in 1 second (FEV1) of at least 80% predicted; and/or improvement of FEV1 equal to or larger than 10%, and a blood eosinophil count lower than 300 cells/mL.
Prior to treatment, the researchers measured eosinophil peroxidase (EPX), immunoglobulin E (IgE), IL-3, IL-4, IL-5, IL-13, IL-25, IL-33, granulocyte-macrophage colony-stimulating factor (GM-CSF), thymic stromal lymphopoietin (TSLP), and eotaxin-1 levels in the sputum of each patient.
At follow-up, 11 patients met the criteria for remission. These patients had significantly higher sputum eosinophil counts, sputum macrophage counts, and lymphocyte counts at baseline, compared with those not in remission (P = .006, P = .02, and P = .04, respectively). Sputum neutrophil percentage levels were significantly lower in patients whose asthma was in remission, compared with those whose asthma was not in remission (P = .007).
At the protein level, remission patients also showed higher baseline levels of sputum eotaxin-1, TSLP, IL-5, EPX, and IgE protein, compared with patients who did not achieve remission (P = .046, P = .04, P = .002, P = .001, and P = .006, respectively).
Overall, EPX and IL-5 measures showed the best combination of sensitivity and specificity, as well as the best area under the curve, the researchers write.
Patients in remission were significantly more likely to be men (8 of 11 patients), a finding that reflected previous studies, the researchers write. The finding of eosinophilic inflammation associated with stronger response to anti–IL-5 therapy also reflected previous studies, but the current study showed that “with a comparable blood eosinophil level at baseline before biotherapy, the response can be highly variable.”
The study findings were limited by several factors, including the small sample size and the lack of a formal definition of remission. Other research needs include an analysis based on nonresponse or suboptimal response predictors, the researchers note.
The results suggest that sputum type 2 markers are potential predictors of remission after anti–IL-5 treatment in adults with severe eosinophilic asthma, although the results must be validated in a larger, multicenter cohort, they conclude.
The study was supported by GlaxoSmithKline and AstraZeneca. Several coauthors have relationships with these companies. Dr. Moermans has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Beware risk of sedatives for respiratory patients
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Both asthma and chronic obstructive pulmonary disease can be challenging to diagnose, and medication-driven episodes of sedation or hypoventilation are often overlooked as causes of acute exacerbations in these conditions, according to a letter published in The Lancet Respiratory Medicine.
write Christos V. Chalitsios, PhD, of the University of Nottingham, England, and colleagues.
The authors note that exacerbations are the main complications of both asthma and COPD, and stress the importance of identifying causes and preventive strategies.
Sedatives such as opioids have been shown to depress respiratory drive, reduce muscle tone, and increase the risk of pneumonia, they write. The authors also propose that the risk of sedative-induced aspiration or hypoventilation would be associated with medications including pregabalin, gabapentin, and amitriptyline.
Other mechanisms may be involved in the association between sedatives and exacerbations in asthma and COPD. For example, sedative medications can suppress coughing, which may promote airway mucous compaction and possible infection, the authors write.
Most research involving prevention of asthma and COPD exacerbations has not addressed the potential impact of sedatives taken for reasons outside of obstructive lung disease, the authors say.
“Although the risk of sedation and hypoventilation events are known to be increased by opioids and antipsychotic drugs, there has not been a systematic assessment of commonly prescribed medications with potential respiratory side-effects, including gabapentin, amitriptyline, and pregabalin,” they write.
Polypharmacy is increasingly common and results in many patients with asthma or COPD presenting for treatment of acute exacerbations while on a combination of gabapentin, pregabalin, amitriptyline, and opioids, the authors note; “however, there is little data or disease-specific guidance on how best to manage this problem, which often starts with a prescription in primary care,” they write. Simply stopping sedatives is not an option for many patients given the addictive nature of these drugs and the unlikely resolution of the condition for which the drugs were prescribed, the authors say. However, “cautious dose reduction” of sedatives is possible once patients understand the reason, they add.
Clinicians may be able to suggest reduced doses and alternative treatments to patients with asthma and COPD while highlighting the risk of respiratory depression and polypharmacy – “potentially reducing the number of exacerbations of obstructive lung disease,” the authors conclude.
The study received no outside funding. The authors have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
No sex bias seen in ACC 22 speaker introductions
Men making speaker introductions at the 2022 annual scientific sessions of the American College of Cardiology were similarly likely to use professional titles regardless of gender, while women making introductions were more likely to use professional titles overall, based on a review of more than 800 videos of last year’s presentations.
“Implicit sex bias in speaker introductions at major medical conferences can foster and drive sex-driven assumptions about the competency of the speaker,” corresponding author Ankur Kalra, MD, an interventional cardiologist at Franciscan Health, Lafayette, Ind., said in an interview. “This is particularly important as recent data have shown a welcome, though gradual increase in the number of women speakers at major cardiology scientific sessions.”
In a research letter published in JACC: Advances, the researchers reviewed 1,696 videos from the ACC meeting held in Washington in April 2022 compiled by ACC Anywhere, and identified the participants as either “introducers” or “speakers.”
The final analysis included 888 speaker-introducer dyads. The introducer population was 49.4% men and 50.6% women; the speaker population included 58.8% men and 41.2% women.
Overall, 77.9% of speakers were addressed professionally in the first mention, and 71.5% were addressed professionally throughout the introduction. When making introductions, full professors were significantly more likely to use nonprofessional address than associate professors, assistant professors, and trainees (28.7% vs. 18.2%, 10.8%, and 0%, respectively).
Regardless of the sex of the speaker, women making introductions were significantly more likely than men to use professional titles for the speaker on first reference and consistently (84.2% vs. 71.5% and 78.2% vs. 64.7%, respectively; P < 0.001 for both).
Men doing introductions used professional forms of address similarly for both men and women speakers on first reference and consistently (72.2% vs. 71.1% and 65.4% vs. 64.3%, respectively).
No significant difference appeared in the use of professional address by women introducing women speakers compared to women introducing men speakers on first reference and consistently (81.9% vs. 86.1% and 75.0% vs. 80.8%, respectively).
“There was no significant association of the formality of introductions with the speaker’s sex and rank,” the researchers noted.
The findings were limited by several factors, including a lack of self-identified sex data, restriction to a binary determination of sex, and a lack of race/ethnicity analysis, the authors noted. In addition, the study could not account for prior familiarity between introducers and speakers that might influence the introduction.
Findings show positive trend
Dr. Kalra was surprised by the study findings, but in a good way. “A recent study on speakers presenting at Internal Medicine grand rounds demonstrated significant sex-based differences in using professional titles for formal introductions for women speakers in comparison with men speakers,” he said in an interview. The current study researchers expected to find similar differences.
“To our pleasant surprise, there was no implicit sex bias in introductions at the ACC 22, as there was no significant difference in the use of professional forms of address by men introducers of women speakers compared with men introducers of men speakers,” he said. “Similarly, the percentage of professional forms of address by women introducers was similar for men and women speakers.”
Setting an example
“A platform like ACC 22 is a window into the world of cardiovascular disease professionals – it’s a snapshot of who we are and what ethos/principles/values we represent,” said Dr. Kalra. “How we introduce one another is a surrogate marker of the mutual respect we behold for one another; our characters are on display, and the world and our junior colleagues are watching. Modern-day cardiology departments and practices must be completely intolerant to subtle microaggressions. The important take-away for clinicians is that it could be that our surprising findings may be attributed to the increased dialogue on sex disparities in cardiology, which has made physicians more cognizant of subtle microaggressions.”
A larger sample size is needed to replicate the study findings, and Dr. Kalra and colleagues hope to include data from ACC’s 2023 meeting, held with the World Congress of Cardiology in March, for additional research in this area.
Time to close inclusion gaps
“The time is now to dive into all previous and current gaps in diversity and inclusion,” Roxana Mehran, MD, said in an interview. “We must understand what the data are, and disseminate and educate all in health care on these issues.”
Dr. Mehran said she was not surprised by the findings of the current study. “This has been my own feeling for many years, watching mostly men be given important roles, such as Grand Rounds Speaking engagements. Now we have the data, and I congratulate the authors for the hard work to dig this out.
“In all aspects, we need to look at the entire talent pool to choose leadership, speakers, and key opinion leaders, as well as principal investigators in clinical trials,” said Dr. Mehran. “This has long been given to our wonderful and talented male colleagues without any effort to look for women, and non-Whites to be given the opportunity to shine and share their talent.”
Looking ahead, “we must remain vigilant and close gaps in all aspects of medicine whether in delivering care, or in the work force; this needs intentional efforts by all.”
The study was funded by makeadent.org and the Ram and Sanjita Kalra Aavishqaar Fund. Dr. Kalra is the CEO and creative director of makeadent.org. The other authors had no financial conflicts to disclose. Dr. Mehran had no financial conflicts to disclose.
Men making speaker introductions at the 2022 annual scientific sessions of the American College of Cardiology were similarly likely to use professional titles regardless of gender, while women making introductions were more likely to use professional titles overall, based on a review of more than 800 videos of last year’s presentations.
“Implicit sex bias in speaker introductions at major medical conferences can foster and drive sex-driven assumptions about the competency of the speaker,” corresponding author Ankur Kalra, MD, an interventional cardiologist at Franciscan Health, Lafayette, Ind., said in an interview. “This is particularly important as recent data have shown a welcome, though gradual increase in the number of women speakers at major cardiology scientific sessions.”
In a research letter published in JACC: Advances, the researchers reviewed 1,696 videos from the ACC meeting held in Washington in April 2022 compiled by ACC Anywhere, and identified the participants as either “introducers” or “speakers.”
The final analysis included 888 speaker-introducer dyads. The introducer population was 49.4% men and 50.6% women; the speaker population included 58.8% men and 41.2% women.
Overall, 77.9% of speakers were addressed professionally in the first mention, and 71.5% were addressed professionally throughout the introduction. When making introductions, full professors were significantly more likely to use nonprofessional address than associate professors, assistant professors, and trainees (28.7% vs. 18.2%, 10.8%, and 0%, respectively).
Regardless of the sex of the speaker, women making introductions were significantly more likely than men to use professional titles for the speaker on first reference and consistently (84.2% vs. 71.5% and 78.2% vs. 64.7%, respectively; P < 0.001 for both).
Men doing introductions used professional forms of address similarly for both men and women speakers on first reference and consistently (72.2% vs. 71.1% and 65.4% vs. 64.3%, respectively).
No significant difference appeared in the use of professional address by women introducing women speakers compared to women introducing men speakers on first reference and consistently (81.9% vs. 86.1% and 75.0% vs. 80.8%, respectively).
“There was no significant association of the formality of introductions with the speaker’s sex and rank,” the researchers noted.
The findings were limited by several factors, including a lack of self-identified sex data, restriction to a binary determination of sex, and a lack of race/ethnicity analysis, the authors noted. In addition, the study could not account for prior familiarity between introducers and speakers that might influence the introduction.
Findings show positive trend
Dr. Kalra was surprised by the study findings, but in a good way. “A recent study on speakers presenting at Internal Medicine grand rounds demonstrated significant sex-based differences in using professional titles for formal introductions for women speakers in comparison with men speakers,” he said in an interview. The current study researchers expected to find similar differences.
“To our pleasant surprise, there was no implicit sex bias in introductions at the ACC 22, as there was no significant difference in the use of professional forms of address by men introducers of women speakers compared with men introducers of men speakers,” he said. “Similarly, the percentage of professional forms of address by women introducers was similar for men and women speakers.”
Setting an example
“A platform like ACC 22 is a window into the world of cardiovascular disease professionals – it’s a snapshot of who we are and what ethos/principles/values we represent,” said Dr. Kalra. “How we introduce one another is a surrogate marker of the mutual respect we behold for one another; our characters are on display, and the world and our junior colleagues are watching. Modern-day cardiology departments and practices must be completely intolerant to subtle microaggressions. The important take-away for clinicians is that it could be that our surprising findings may be attributed to the increased dialogue on sex disparities in cardiology, which has made physicians more cognizant of subtle microaggressions.”
A larger sample size is needed to replicate the study findings, and Dr. Kalra and colleagues hope to include data from ACC’s 2023 meeting, held with the World Congress of Cardiology in March, for additional research in this area.
Time to close inclusion gaps
“The time is now to dive into all previous and current gaps in diversity and inclusion,” Roxana Mehran, MD, said in an interview. “We must understand what the data are, and disseminate and educate all in health care on these issues.”
Dr. Mehran said she was not surprised by the findings of the current study. “This has been my own feeling for many years, watching mostly men be given important roles, such as Grand Rounds Speaking engagements. Now we have the data, and I congratulate the authors for the hard work to dig this out.
“In all aspects, we need to look at the entire talent pool to choose leadership, speakers, and key opinion leaders, as well as principal investigators in clinical trials,” said Dr. Mehran. “This has long been given to our wonderful and talented male colleagues without any effort to look for women, and non-Whites to be given the opportunity to shine and share their talent.”
Looking ahead, “we must remain vigilant and close gaps in all aspects of medicine whether in delivering care, or in the work force; this needs intentional efforts by all.”
The study was funded by makeadent.org and the Ram and Sanjita Kalra Aavishqaar Fund. Dr. Kalra is the CEO and creative director of makeadent.org. The other authors had no financial conflicts to disclose. Dr. Mehran had no financial conflicts to disclose.
Men making speaker introductions at the 2022 annual scientific sessions of the American College of Cardiology were similarly likely to use professional titles regardless of gender, while women making introductions were more likely to use professional titles overall, based on a review of more than 800 videos of last year’s presentations.
“Implicit sex bias in speaker introductions at major medical conferences can foster and drive sex-driven assumptions about the competency of the speaker,” corresponding author Ankur Kalra, MD, an interventional cardiologist at Franciscan Health, Lafayette, Ind., said in an interview. “This is particularly important as recent data have shown a welcome, though gradual increase in the number of women speakers at major cardiology scientific sessions.”
In a research letter published in JACC: Advances, the researchers reviewed 1,696 videos from the ACC meeting held in Washington in April 2022 compiled by ACC Anywhere, and identified the participants as either “introducers” or “speakers.”
The final analysis included 888 speaker-introducer dyads. The introducer population was 49.4% men and 50.6% women; the speaker population included 58.8% men and 41.2% women.
Overall, 77.9% of speakers were addressed professionally in the first mention, and 71.5% were addressed professionally throughout the introduction. When making introductions, full professors were significantly more likely to use nonprofessional address than associate professors, assistant professors, and trainees (28.7% vs. 18.2%, 10.8%, and 0%, respectively).
Regardless of the sex of the speaker, women making introductions were significantly more likely than men to use professional titles for the speaker on first reference and consistently (84.2% vs. 71.5% and 78.2% vs. 64.7%, respectively; P < 0.001 for both).
Men doing introductions used professional forms of address similarly for both men and women speakers on first reference and consistently (72.2% vs. 71.1% and 65.4% vs. 64.3%, respectively).
No significant difference appeared in the use of professional address by women introducing women speakers compared to women introducing men speakers on first reference and consistently (81.9% vs. 86.1% and 75.0% vs. 80.8%, respectively).
“There was no significant association of the formality of introductions with the speaker’s sex and rank,” the researchers noted.
The findings were limited by several factors, including a lack of self-identified sex data, restriction to a binary determination of sex, and a lack of race/ethnicity analysis, the authors noted. In addition, the study could not account for prior familiarity between introducers and speakers that might influence the introduction.
Findings show positive trend
Dr. Kalra was surprised by the study findings, but in a good way. “A recent study on speakers presenting at Internal Medicine grand rounds demonstrated significant sex-based differences in using professional titles for formal introductions for women speakers in comparison with men speakers,” he said in an interview. The current study researchers expected to find similar differences.
“To our pleasant surprise, there was no implicit sex bias in introductions at the ACC 22, as there was no significant difference in the use of professional forms of address by men introducers of women speakers compared with men introducers of men speakers,” he said. “Similarly, the percentage of professional forms of address by women introducers was similar for men and women speakers.”
Setting an example
“A platform like ACC 22 is a window into the world of cardiovascular disease professionals – it’s a snapshot of who we are and what ethos/principles/values we represent,” said Dr. Kalra. “How we introduce one another is a surrogate marker of the mutual respect we behold for one another; our characters are on display, and the world and our junior colleagues are watching. Modern-day cardiology departments and practices must be completely intolerant to subtle microaggressions. The important take-away for clinicians is that it could be that our surprising findings may be attributed to the increased dialogue on sex disparities in cardiology, which has made physicians more cognizant of subtle microaggressions.”
A larger sample size is needed to replicate the study findings, and Dr. Kalra and colleagues hope to include data from ACC’s 2023 meeting, held with the World Congress of Cardiology in March, for additional research in this area.
Time to close inclusion gaps
“The time is now to dive into all previous and current gaps in diversity and inclusion,” Roxana Mehran, MD, said in an interview. “We must understand what the data are, and disseminate and educate all in health care on these issues.”
Dr. Mehran said she was not surprised by the findings of the current study. “This has been my own feeling for many years, watching mostly men be given important roles, such as Grand Rounds Speaking engagements. Now we have the data, and I congratulate the authors for the hard work to dig this out.
“In all aspects, we need to look at the entire talent pool to choose leadership, speakers, and key opinion leaders, as well as principal investigators in clinical trials,” said Dr. Mehran. “This has long been given to our wonderful and talented male colleagues without any effort to look for women, and non-Whites to be given the opportunity to shine and share their talent.”
Looking ahead, “we must remain vigilant and close gaps in all aspects of medicine whether in delivering care, or in the work force; this needs intentional efforts by all.”
The study was funded by makeadent.org and the Ram and Sanjita Kalra Aavishqaar Fund. Dr. Kalra is the CEO and creative director of makeadent.org. The other authors had no financial conflicts to disclose. Dr. Mehran had no financial conflicts to disclose.
FROM JACC: ADVANCES