TY - JOUR T1 - QVA149 does not increase the risk of cardio- and cerebro-vascular events, pneumonia and exacerbation events compared with placebo: A network meta-analysis across multiple safety databases JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P3638 AU - Hungta Chen AU - Peter D'Andrea AU - Donald Banerji Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P3638.abstract N2 - IntroductionQVA149 combines the long-acting β2-agonist indacaterol (IND) and long-acting muscarinic antagonist glycopyrronium (GLY) as a dual bronchodilator for the treatment of COPD. Safety information from data in the QVA149 IGNITE program was integrated with available relevant information from the IND and GLY safety databases to investigate the impact of individual patient level factors and time.MethodsA network meta-analysis using individual patient data was carried out, focusing on deaths, serious cardio- and cerebro-vascular (CCV) events, major adverse cardiovascular events (MACE), serious pneumonia, serious COPD exacerbation and atrial fibrillation/flutter (AF/F). All completed randomized clinical studies of QVA149, IND and GLY of ≥3 months duration with at least two of the following treatment groups were included in the meta-analysis: QVA149 110/50µg, GLY 50µg, IND 150µg, open-label tiotropium 18µg and placebo. The analysis used Cox proportional hazard model.ResultsThe hazard ratio (HR) for QVA149 versus placebo showed no significant increase in risk for death (HR [95%CI]: 0.922 [0.338-2.511]), serious CCV (0.597 [0.287-1.241]), MACE (0.984 [0.417-2.319]), serious pneumonia (1.076 [0.526-2.203]), serious COPD exacerbation (0.598 [0.395-0.906]), or AF/F (1.017 [0.479-2.157]).ConclusionsBased on the analysis of the available safety databases, in COPD patients there is no evidence of increased risk of all-cause mortality, serious CCV, MACE, serious pneumonia, serious exacerbations and AF/F with QVA149 compared with placebo. ER -