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

153 Citations (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.

Original languageEnglish
JournalAmerican Journal of Respiratory and Critical Care Medicine
Volume201
Issue number12
Pages (from-to)1508-1516
Number of pages9
ISSN1073-449X
DOIs
Publication statusPublished - 15 Jun 2020

Keywords

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists/therapeutic use
  • Aged
  • Androstadienes/therapeutic use
  • Benzyl Alcohols/therapeutic use
  • Cause of Death
  • Chlorobenzenes/therapeutic use
  • Drug Therapy, Combination
  • Female
  • Forced Expiratory Volume
  • Glucocorticoids/therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Mortality
  • Muscarinic Antagonists/therapeutic use
  • Proportional Hazards Models
  • Pulmonary Disease, Chronic Obstructive/drug therapy
  • Quinuclidines/therapeutic use
  • Severity of Illness Index
  • Survival
  • Triple therapy
  • COPD

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