title: A Systematic Review of the Efficacy and Safety of a Fixed-Dose Combination of Umeclidinium and Vilanterol for the Treatment of COPD.
abstract: BACKGROUND
  COPD guidelines recommend the combined use of inhaled long-acting β2-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 (UMEC)/vilanterol (VIL), would translate into better outcomes without incurring increased adverse events (AEs).
  
  
  METHODS
  This was a systematic review of randomized, placebo-controlled or crossover trials (> 4 weeks) involving UMEC/VIL compared with its monocomponents, tiotropium, or fluticasone/salmeterol. Primary outcomes were trough FEV1, serious adverse events (SAEs), and serious cardiovascular events (SCVEs).
  
  
  RESULTS
  Eleven trials from 10 studies (9,609 patients) showed that UMEV/VIL provided superior improvements in lung function compared with UMEC, VIL, tiotropium, and fluticasone propionate/salmeterol (mean trough FEV1, 60, 110, 90, and 90 mL, respectively; P < .0001). Also, UMEC/VIL had a greater likelihood of demonstrating a minimal clinically important difference on the Transition Dyspnea Index 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 between UMEC/VIL and tiotropium with respect to dyspnea, health status, or risk of COPD exacerbation. Regarding safety issues, the incidence of AEs, SAEs, SCVEs, and mortality on treatment was similar across treatments, suggesting reduced safety concerns with the use of the UMEC/VIL combination.
  
  
  CONCLUSIONS
  Once-daily inhaled UMEC/VIL showed superior efficacy compared with its monocomponents, tiotropium, and fluticasone/combination in patients with moderate to severe COPD.
authors: Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay. Electronic address: gustavo.javier.rodrigo@gmail.com.
authors: Gustavo J
authors: GJ
authors: Rodrigo
authors: Unidad de Medicina Respiratoria, Hospital de Niños "O. Santa Fe, Argentina.
authors: Hugo
authors: H
authors: Neffen
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use*; D000420:Albuterol / Q000031:analogs & derivatives / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use; D001592:Benzyl Alcohols / Q000627:therapeutic use*; D002722:Chlorobenzenes / Q000627:therapeutic use*; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011812:Quinuclidines / Q000627:therapeutic use*; D012602:Scopolamine Derivatives / Q000627:therapeutic use; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001592:Benzyl Alcohols; D002722:Chlorobenzenes; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; C573971:GSK573719; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D012602:Scopolamine Derivatives; C550468:vilanterol; D000420:Albuterol; D000069447:Tiotropium Bromide