QVA149 demonstrated similar cardio- and cerebrovascular safety compared to standard COPD treatments, with major adverse cardiac events occurring in 0.8% of treated patients.
Does QVA149 increase the risk of cardio- and cerebrovascular events compared to monotherapies, other standard COPD treatments, or placebo in patients with moderate-to-very severe COPD?
The dual bronchodilator QVA149 has a cardio- and cerebrovascular safety profile similar to its mono-components and other standard COPD treatments.
Introduction QVA149 is an approved once-daily dual bronchodilator combining indacaterol (IND) and glycopyrronium (GLY), for maintenance treatment of COPD. Patients (pts) with COPD often suffer cardio- and cerebrovascular (CCV) co-morbidities, we herein report the CCV safety of QVA149 in comparison with IND, GLY, tiotropium (TIO), salmeterol/fluticasone (SFC) and placebo (PBO) based on the IGNITE registration program. Methods Data was pooled from the QVA149 safety database consisting of phase III pivotal clinical studies (ARISE, SHINE, SPARK, ENLIGHTEN and ILLUMINATE) with a duration of ≥6 months. Pts in this database are representative of a general COPD population as in other clinical trials of IND, GLY and other LAMAs. All CCV adverse events (AEs) as well as adjudicated CCV serious AEs (major adverse cardiac events MACE and Non-MACE) were analysed. Results 5359 patients were included in the safety evaluation. Compared with PBO and active comparators, QVA149 showed similar frequencies of CCV events in pts with COPD (table). QVA149 also showed consistently lower or similar frequencies of respiratory infections and other respiratory AEs compared to PBO and active comparators. Patients n(%) with CCV AEs and SAEs QVA149 IND GLY TIO SFC PBO N 1805 476 1213 1256 264 345 CCV AEs 71(3.9) 12(2.5) 64(5.3) 59(4.7) 6(2.3) 9(2.6) CCV SAEs 32(1.8) 4(0.8) 30(2.5) 28(2.2) 3(1.1) 1(0.3) MACE 14(0.8) 2(0.4) 18(1.5) 11(0.9) 1(0.3) 0 Non-MACE 18(1.0) 2(0.4) 12(1.5) 17(1.3) 2(0.6) 1(0.4) Conclusion Overall CCV safety profile of QVA149 is similar to its mono-components and other standard COPD treatments, providing reassurance for safe use as a regular long-term treatment in pts with moderate to very severe COPD.
Dahl et al. (2014) studied this question. QVA149 demonstrated similar cardio- and cerebrovascular safety compared to standard COPD treatments, with major adverse cardiac events occurring in 0.8% of treated patients.