title: Comparative efficacy of indacaterol 150 μg and 300 μg versus fixed-dose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease--a network meta-analysis.
abstract: OBJECTIVE
  To compare efficacy of indacaterol to that of fixed-dose combination (FDC) formoterol and budesonide (FOR/BUD) and FDC salmeterol and fluticasone (SAL/FP) for the treatment of chronic obstructive pulmonary disease (COPD) based on the available randomized clinical trials (RCTs).
  
  
  METHODS
  Fifteen placebo-controlled RCTs were included that evaluated: indacaterol 150 μg (n = 5 studies), indacaterol 300 μg (n = 4), FOR/BUD 9/160 μg (n = 2), FOR/BUD 9/320 μg (n = 3), SAL/FP 50/500 μg (n = 5), and SAL/FP 50/250 μg (n = 1). Outcomes of interest were trough forced expiratory volume in 1 second (FEV(1)), total scores for St. George's Respiratory Questionnaire (SGRQ), and transition dyspnea index (TDI). All trials were analyzed simultaneously using a Bayesian network meta-analysis and relative treatment effects between all regimens were obtained. Treatment-by-covariate interactions were included where possible to improve the similarity of the trials.
  
  
  RESULTS
  Indacaterol 150 μg resulted in a higher change from baseline (CFB) in FEV(1) at 12 weeks compared to FOR/BUD 9/160 μg (difference in CFB 0.11 L [95% credible intervals: 0.08, 0.13]) and FOR/BUD 9/320 μg (0.09 L [0.06, 0.11]) and was comparable to SAL/FP 50/250 μg (0.02 L [-0.04, 0.08]) and SAL/FP 50/500 μg (0.03 L [0.00, 0.06]). Similar results were observed for indacaterol 300 μg at 12 weeks and indacaterol 150/300 μg at 6 months. Indacaterol 150 μg demonstrated comparable improvement in SGRQ total score at 6 months versus FOR/BUD (both doses), and SAL/FP 50/500 μg (-2.16 point improvement [-4.96, 0.95]). Indacaterol 150 and 300 μg demonstrated comparable TDI scores versus SAL/FP 50/250 μg (0.21 points (-0.57, 0.99); 0.39 [-0.39, 1.17], respectively) and SAL/FP 50/500 μg at 6 months.
  
  
  CONCLUSIONS
  Indacaterol monotherapy is expected to be at least as good as FOR/BUD (9/320 and 9/160 μg) and comparable to SAL/FP (50/250 and 50/500 μg) in terms of lung function. Indacaterol is also expected to be comparable to FOR/BUD (9/320 and 9/160 μg) and SAL/FP 50/500 μg in terms of health status and to SAL/FP (50/250 and 50/500 μg) in terms of breathlessness.
authors.affiliation: Mapi Values, Boston, MA, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Cope
authors.forename: Gorana
authors.initials: G
authors.lastname: Capkun-Niggli
authors.forename: Rupert
authors.initials: R
authors.lastname: Gale
authors.forename: José R
authors.initials: JR
authors.lastname: Jardim
authors.forename: Jeroen P
authors.initials: JP
authors.lastname: Jansen
mesh_terms: D006801:Humans; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives; D000730:Androstadienes / Q000008:administration & dosage; D001993:Bronchodilator Agents / Q000008:administration & dosage; D019819:Budesonide / Q000008:administration & dosage; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage; D000068297:Fluticasone-Salmeterol Drug Combination; D000068759:Formoterol Fumarate; D007189:Indans / Q000008:administration & dosage; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy; D015363:Quinolones / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000420:Albuterol; D000730:Androstadienes; D001993:Bronchodilator Agents; D019819:Budesonide; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D000068759:Formoterol Fumarate; C510790:indacaterol; D007189:Indans; D015363:Quinolones