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

David A Lipson, Courtney Crim, Gerard J Criner, Nicola C Day, Mark T Dransfield, David M G Halpin, MeiLan K Han, C Elaine Jones, Sally Kilbride, Peter Lange, David A Lomas, Sally Lettis, Pamela Manchester, Neil Martin, Dawn Midwinter, Andrea Morris, Steven J Pascoe, Dave Singh, Robert A Wise, Fernando J Martinez

152 Citationer (Scopus)

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 mg, FF/VI 100/25 mg, or UMEC/VI 62.5/25 mg 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.

OriginalsprogEngelsk
TidsskriftAmerican Journal of Respiratory and Critical Care Medicine
Vol/bind201
Udgave nummer12
Sider (fra-til)1508-1516
Antal sider9
ISSN1073-449X
DOI
StatusUdgivet - 15 jun. 2020

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