TY - JOUR T1 - Cardio- and cerebrovascular safety of QVA149 in patients with moderate-to-very severe COPD: A pooled analysis JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P289 AU - Ronald Dahl AU - Roland Buhl AU - Karen Mezzi AU - Agnes Schubert-Tennigkeit AU - Hungta Chen AU - Donald Banerji AU - Robert Fogel Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P289.abstract N2 - IntroductionQVA149 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.MethodsData 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.Results5359 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.View this table:Patients [n(%)] with CCV AEs and SAEsConclusionOverall 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. ER -