Abstract
Introduction
QVA149 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.
Methods
A 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.
Results
The 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]).
Conclusions
Based 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.
- © 2013 ERS