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

Background: Fluticasone 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.

Objective: To 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.

Methods: Randomized, 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]).

Results: Seven 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.

Conclusion: Fluticasone 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.