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- Title
Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease.
- Authors
Lipson, David A; Crim, Courtney; Criner, Gerard J; Day, Nicola C; Dransfield, Mark T; Halpin, David M G; Han, MeiLan K; Jones, C Elaine; Kilbride, Sally; Lange, Peter; Lomas, David A; Lettis, Sally; Manchester, Pamela; Martin, Neil; Midwinter, Dawn; Morris, Andrea; Pascoe, Steve J; Singh, Dave; Wise, Robert A; Martinez, Fernando J
- Abstract
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.
- Subjects
FLUTICASONE; OBSTRUCTIVE lung diseases; MORTALITY; SECONDARY analysis; ACQUISITION of data; THERAPEUTIC use of glucocorticoids; STEROID drugs; BENZENE derivatives; ADRENERGIC beta agonists; CAUSES of death; RESEARCH; COMBINATION drug therapy; HETEROCYCLIC compounds; RESEARCH methodology; EVALUATION research; MEDICAL cooperation; SEVERITY of illness index; COMPARATIVE studies; FORCED expiratory volume; ALCOHOLS (Chemical class); INHALATION administration; MUSCARINIC antagonists; PROPORTIONAL hazards models
- Publication
American Journal of Respiratory & Critical Care Medicine, 2020, Vol 201, Issue 12, p1508
- ISSN
1073-449X
- Publication type
journal article
- DOI
10.1164/rccm.201911-2207OC