Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease.

Autor: Lipson DA; Clinical Sciences.; Pulmonary, Allergy and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania., Crim C; Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina., Criner GJ; Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania., Day NC; Safety and Medical Governance and., Dransfield MT; Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama., Halpin DMG; University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom., Han MK; University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan., Jones CE; Development, R&D, and., Kilbride S; Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom., Lange P; Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.; Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark., Lomas DA; UCL Respiratory, University College London, London, United Kingdom., Lettis S; Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom., Manchester P; Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania., Martin N; Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.; Institute for Lung Health, University of Leicester, Leicester, United Kingdom., Midwinter D; Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom., Morris A; Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina., Pascoe SJ; Clinical Sciences., Singh D; Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom., Wise RA; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and., Martinez FJ; New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
Jazyk: angličtina
Zdroj: American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2020 Jun 15; Vol. 201 (12), pp. 1508-1516.
DOI: 10.1164/rccm.201911-2207OC
Abstrakt: Rationale: The IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial demonstrated a significant reduction in all-cause mortality (ACM) risk with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) at risk of future exacerbations. Five hundred seventy-four patients were censored in the original analysis owing to incomplete vital status information. Objectives: Report ACM and impact of stepping down therapy, following collection of additional vital status data. Methods: Patients were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg following a run-in on their COPD therapies. Time to ACM was prespecified. Additional vital status data collection and subsequent analyses were performed post hoc . Measurements and Main Results: We report vital status data for 99.6% of the intention-to-treat population ( n  = 10,355), documenting 98 (2.36%) deaths on FF/UMEC/VI, 109 (2.64%) on FF/VI, and 66 (3.19%) on UMEC/VI. For FF/UMEC/VI, the hazard ratio for death was 0.72 (95% confidence interval, 0.53-0.99; P  = 0.042) versus UMEC/VI and 0.89 (95% confidence interval, 0.67-1.16; P  = 0.387) versus FF/VI. Independent adjudication confirmed lower rates of cardiovascular and respiratory death and death associated with the patient's COPD. Conclusions: In this secondary analysis of an efficacy outcome from the IMPACT trial, once-daily single-inhaler FF/UMEC/VI triple therapy reduced the risk of ACM versus UMEC/VI in patients with symptomatic COPD and a history of exacerbations.
Databáze: MEDLINE
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