Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction.
Martinez FJ., Vestbo J., Anderson JA., Brook RD., Celli BR., Cowans NJ., Crim C., Dransfield M., Kilbride S., Yates J., Newby DE., Niewoehner D., Calverley PMA., SUMMIT Investigators None.
RATIONALE: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear. OBJECTIVES: This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study. METHODS: In a double-blind, randomized controlled trial, once-daily inhaled placebo, fluticasone furoate (FF; 100 μg), vilanterol (VI; 25 μg), or the combination of FF/VI was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional predefined endpoint. A total of 1,368 centers in 43 countries and 16,485 patients with moderate COPD and heightened cardiovascular risk were included in the study. MEASUREMENTS AND MAIN RESULTS: Compared with placebo, FF/VI reduced the rate of moderate and/or severe exacerbations by 29% (95% confidence interval [CI], 22-35; P