A SYSTEMATIC REVIEW ON THE EFFICACY AND SAFETY OF A FIXED-DOSE COMBINATION OF UMECLIDINIUM AND VILANTEROL FOR THE TREATMENT OF COPD.
Chest. 2015 Mar 12;
Authors: Rodrigo GJ, Neffen H
Background: COPD guidelines recommend the combined use of inhaled long-acting beta2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) if symptoms are not improved by a single agent. This systematic review tested the hypothesis that the bronchodilator effect of the LABA/LAMA combination, umeclidinium/vilanterol (UMEC/VIL), would translate into better outcomes without incurring increased adverse events (AEs).
Methods: This is a systematic review of randomized, placebo-controlled or cross-over trials (>4 weeks) involving UMEC/VIL compared to its monocomponents, tiotropium or fluticasone/salmeterol. Primary outcomes were trough forced expiratory volume in the first second (FEV1), severe AEs and serious cardiovascular events (SCVEs).
Results: Eleven trials from ten studies (9,609 patients) showed that UMEV/VIL provided superior improvements in lung function compared with UMEC, VIL, tiotropium and FSC (mean trough FEV1 60, 110, 90, and 90 mL respectively, p <0.0001). Also, UMEC/VIL had a greater likelihood of demonstrating a minimal clinical important difference (MCID) in TDI compared with UMEC, and VIL (Number needed to treat for benefit [NNTB] = 14 and 10 respectively). UMEC/VIL therapy significantly reduced the risk of COPD exacerbations compared with UMEC and VIL (NNTB = 42 and 41 respectively). On the contrary, we noted no significant differences with respect to dyspnea, health status, and risk of COPD exacerbation between UMEC/VIL and tiotropium. Regarding safety issues, the incidence of AEs, SAEs, SCVEs and mortality on treatment was similar across treatments suggesting reduced safety concerns with use of UMEC/VIL combination.
Conclusions: Once-daily inhaled UMEC/VIL showed superior efficacy compared with monocomponents, tiotropium and fluticasone/combination in patients with moderate-to-severe COPD.
PMID: 25798635 [PubMed - as supplied by publisher]