title: A systematic review with meta-analysis of fluticasone furoate/vilanterol combination for the treatment of stable COPD.
abstract: Current guidelines recommend the use of inhaled corticosteroids/long-acting beta2-agonists as first-line therapy for COPD patients at risk for acute exacerbations and/or severe airflow limitation. This systematic review assesses available evidence on the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) combination versus each alone, for the treatment of patients with severe to very severe stable COPD.
  
  
  
  Randomized, placebo-controlled trials of >8 weeks of duration were included. Primary end points were pulmonary function, COPD exacerbations and serious adverse events. FF/VI was compared with its mono-components.
  
  
  
  Five reports with six trials (n = 15,515 patients) met the entry criteria. FF/VI was associated with significant increases in trough FEV1compared with vilanterol (VI) and fluticasone furoate (FF) (45 mL and 90 mL respectively). FF/VI significantly reduced the number of subjects with at least one moderate to severe exacerbation compared with VI (number needed to treat for benefit [NNTB] = 21) and with FF (NNTB = 26). There were no statistical differences in the rates of serious adverse events, cardiac events and all-cause mortality. On the contrary, FF/VI showed a significant 52% increase in the rate of pneumonia compared with VI monotherapy (5.3% vs. 3.5%). However, there was no difference in the rate of pneumonia when FF/VI was compared with FF alone.
  
  
  
  FF/VI combination was associated with a decrease of the rate of COPD exacerbations, without affecting mortality or cardiovascular outcomes in patients with moderate to severe stable COPD. Also, the use of FF was associated with an increased risk of pneumonia.
authors.affiliation: Departamento de Emergencia, Hospital Central de las Fuerzas Armadas, Av. 8 de Octubre 3020, Montevideo 11300, Uruguay. Electronic address: gustavo.javier.rodrigo@gmail.com.
authors.forename: Gustavo J
authors.initials: GJ
authors.lastname: Rodrigo
authors.affiliation: Centro de Alergia, Inmunología y Enfermedades Respiratorias Santa Fe, Argentina. Electronic address: hugoneffen@gmail.com.
authors.forename: Hugo
authors.initials: H
authors.lastname: Neffen
mesh_terms: D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001592:Benzyl Alcohols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002722:Chlorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D006801:Humans; D011014:Pneumonia / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
chemical_list: D000730:Androstadienes; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; C000611924:fluticasone furoate-vilanterol trifenatate
keywords: Chronic obstructive pulmonary disease; Combination inhaler; Fluticasone furoate; Vilanterol