3 research outputs found
Sex differences in mortality in patients with COPD
Little is known about survival and clinical prognostic factors in females with chronic
obstructive pulmonary disease (COPD). The aim of the present study was to determine the
survival difference between males and females with COPD and to compare the value of the
different prognostic factors for the disease.
In total, 265 females and 272 males with COPD matched at baseline by BODE (body mass index,
airflow obstruction, dyspnoea, exercise capacity) and American Thoracic Society/European
Respiratory Society/Global Initiative of Chronic Obstructive Lung Disease criteria were
prospectively followed. Demographics, lung function, St George’s Respiratory Questionnaire,
BODE index, the components of the BODE index and comorbidity were determined. Survival was
documented and sex differences were determined using Kaplan–Meier analysis. The strength of
the association of the studied variables with mortality was determined using multivariate and
receiver operating curves analysis.
All-cause (40 versus 18%) and respiratory mortality (24 versus 10%) were higher in males than
females. Multivariate analysis identified the BODE index in females and the BODE index and
Charlson comorbidity score in males as the best predictors of mortality. The area under the curve
of the BODE index was a better predictor of mortality than the forced expiratory volume in one
second for both sexes.
At similar chronic obstructive pulmonary disease severity by BODE index and forced expiratory
volume in one second, females have significantly better survival than males. For both sexes the
BODE index is a better predictor of survival than the forced expiratory volume in one second
Sex differences in mortality in patients with COPD
Little is known about survival and clinical prognostic factors in females with chronic
obstructive pulmonary disease (COPD). The aim of the present study was to determine the
survival difference between males and females with COPD and to compare the value of the
different prognostic factors for the disease.
In total, 265 females and 272 males with COPD matched at baseline by BODE (body mass index,
airflow obstruction, dyspnoea, exercise capacity) and American Thoracic Society/European
Respiratory Society/Global Initiative of Chronic Obstructive Lung Disease criteria were
prospectively followed. Demographics, lung function, St George’s Respiratory Questionnaire,
BODE index, the components of the BODE index and comorbidity were determined. Survival was
documented and sex differences were determined using Kaplan–Meier analysis. The strength of
the association of the studied variables with mortality was determined using multivariate and
receiver operating curves analysis.
All-cause (40 versus 18%) and respiratory mortality (24 versus 10%) were higher in males than
females. Multivariate analysis identified the BODE index in females and the BODE index and
Charlson comorbidity score in males as the best predictors of mortality. The area under the curve
of the BODE index was a better predictor of mortality than the forced expiratory volume in one
second for both sexes.
At similar chronic obstructive pulmonary disease severity by BODE index and forced expiratory
volume in one second, females have significantly better survival than males. For both sexes the
BODE index is a better predictor of survival than the forced expiratory volume in one second
Recommended from our members
Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial
We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.
In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.
Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88–1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.
Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.
US National Institutes of Health and Operation Warp Spee