ArticleChronic obstructive pulmonary diseases (Miami, Fla.)2024
The Effect of Patient Sex on Treatment Outcomes in COPD: A Post Hoc Analysis of the IMPACT Trial.
Article in Chronic obstructive pulmonary diseases (Miami, Fla.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Lung physiology and chronic obstructive pulmonary disease (COPD) pathophysiology differ between sexes. This post hoc analysis investigated the InforMing the Pathway of COPD Treatment (IMPACT) trial outcomes by patient sex. Methods: IMPACT was a double-blind, 52-week trial. Patients ≥40 years with symptomatic COPD and a history of exacerbations were randomized 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25μg, FF/VI 100/25μg, or UMEC/VI 62.5/25μg. Annual rate and risk of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 second (FEV Results: Of 10,355 patients, 66.3% were male. More females reported ≥2 moderate/severe prior exacerbations (58% versus 53%) at screening versus males. Additionally, females had worse mean (standard deviation) SGRQ scores (52.4[15.97] versus 49.8[17.24]) at baseline. FF/UMEC/VI improved annual exacerbation rate, lung function, and health status for both sexes versus dual therapy. The difference in trough FEV Conclusion: More females with COPD reported exacerbations in the prior year at screening, as well as during the study, versus males, across all treatments. FF/UMEC/VI improved exacerbation rates versus UMEC/VI in females with eosinophil counts <150 cells/µL or <2 exacerbations in the prior year, suggesting inhaled corticosteroids may play an important role in exacerbation reduction for females in this patient population. Clinical Trial Registration: GSK (CTT116855/NCT021645B).
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