Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD

作者：David A. Lipson, Frank Barnhart, Noushin Brealey, Jean Brooks, Gerard J. Criner, Nicola C. Day, Mark T. Dransfield, David Halpin, MeiLan K. Han, Christine Jones, Sally Kilbride, Peter Lange, David A. Lomas, Fernando J. Martínez, Dave Singh, Maggie Tabberer, Robert A. Wise, Steven Pascoe · 发表于：New England Journal of Medicine · 年份：2018 · DOI：10.1056/nejmoa1713901 · 被引用次数：1297 · 研究领域：Chronic Obstructive Pulmonary Disease (COPD) Research、Inhalation and Respiratory Drug Delivery、Asthma and respiratory diseases

BACKGROUND: -agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid-LABA or LAMA-LABA), are uncertain. METHODS: In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate-vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium-vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. RESULTS: The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as compared with 1.07 per year in the fluticasone furoate-vilanterol group (rate ratio with triple therapy, 0.85; 95% confidence interval [CI], 0.80 to 0.90; 15% difference; P<0.001) and 1.21 per year in the umeclidinium-vilanterol group (rate ratio with triple therapy, 0.75; 95% CI, 0.70 to 0.81; 25% difference; P<0.001). The annual rate of severe exacerbations resulting in hospitalization in the triple-therapy group was 0.13, as compared with 0.19 in the umeclidinium-vilanterol group (rate ratio, 0.66; 95% CI, 0.56 to 0.78; 34% difference; P<0.001). There was a higher incidence of pneumonia in the inhaled-glucocorticoid groups than in the umeclidinium-vi...