Umeclidinium Plus Vilanterol Versus Placebo, Umeclidinium, or Vilanterol Monotherapies for Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The role of umeclidinium plus vilanterol as a combination therapy for chronic obstructive pulmonary disease (COPD) has not yet been clearly defined. OBJECTIVE: The aim of this meta-analysis was to evaluate the efficacy and safety of umeclidinium plus vilanterol, in contrast to either monotherapy or placebo. METHODS: Systematic searches were conducted in Pubmed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and the Chinese Biomedical Literature Database (CBM). Randomized clinical trials pertaining to the treatment of COPD with the combination of umeclidinium and vilanterol, versus umeclidinium, vilanterol or placebo, were reviewed. Studies were pooled to mean differences (MDs), with 95 % confidence intervals (CIs). RESULTS: Six studies were included in our meta-analysis. The application of umeclidinium plus vilanterol compared with umeclidinium alone showed increases in trough forced expiratory volume in 1 s [FEV1] (MD 0.05 L, 95 % CI 0.04-0.07; p < 0.00001) and forced vital capacity [FVC] (MD 0.07 L, 95 % CI 0.04-0.10; p < 0.00001). Similarly, versus vilanterol alone, the application of umeclidinium plus vilanterol showed increases in trough FEV1 (MD 0.10, 95 % CI 0.08-0.12; p < 0.00001) and FVC (MD 0.16 L, 95 % CI 0.13-0.20; p < 0.00001). Compared with placebo, umeclidinium plus vilanterol also showed increases in trough FEV1 (MD 0.21 L, 95 % CI 0.19-0.22; p < 0.00001) and FVC (MD 0.31 L, 95 % CI 0.26-0.35; p < 0.00001). In addition, umeclidinium plus vilanterol has beneficial effects on dyspnea, albuterol use, and health-related quality of life compared with the other three groups. CONCLUSIONS: Compared with the other three groups, i.e. placebo, umeclidinium and vilanterol, umeclidinium plus vilanterol improves lung function and quality of life in patients with COPD, reduces the use of albuterol, and does not increase the incidence of adverse events and serious adverse events.