Once-daily fluticasone furoate and vilanterol for adolescents and adults with symptomatic asthma: A systematic review with meta-analysis

Abstract

BackgroundFluticasone furoate and vilanterol is a new inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA) combination developed for once-daily administration via a dry powder inhaler. ObjectiveTo assess the efficacy and safety of fluticasone furoate–vilanterol in adolescents and adults with symptomatic asthma compared with ICS monotherapy or twice-daily ICS-LABA formulations. MethodsRandomized, placebo-controlled trials with longer than 8 weeks of treatment duration were included. Primary outcome was pulmonary function (forced expiratory volume in 1 second [FEV1] or peak expiratory flow rate [PEF]). ResultsSeven published randomized clinical trials were included (5,668 patients). Fluticasone furoate–vilanterol was associated with significant increases in trough FEV1 and morning and evening PEF compared with fluticasone furoate, 100 μg, monotherapy (90 mL, 20.1 L/min, and 18.9 L/min respectively). Fluticasone furoate–vilanterol reduced significantly the rate of severe asthma exacerbations (number need to treat for benefit = 24). Fluticasone furoate–vilanterol also produced significant increases in weighted FEV1 and morning and evening PEF (140 mL, 32.6 L/min, and 25.7 L/min, respectively) compared with fluticasone propionate, 500 μg twice daily. Fluticasone furoate–vilanterol presented a nonsignificant increase in the frequency of cardiac events (6.4% vs 1.8%) compared with fluticasone propionate. No differences were found between both available doses of fluticasone furoate–vilanterol (200/25 μg and 100/25 μg) in terms of efficacy. However, patients receiving fluticasone furoate–vilanterol, 200/25 μg, had a trend toward an increased risk of cardiac events. ConclusionFluticasone furoate–vilanterol combination was associated with an increase in trough FEV1 compared with fluticasone furoate–fluticasone propionate; however, observed differences may not be clinically significant. Studies comparing fluticasone furoate–vilanterol with fixed twice-daily ICS-LABA combinations are required.