TY - JOUR T1 - Once-daily QVA149 has a good safety profile in patients with COPD JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P757 AU - Tobias Welte AU - Claus Vogelmeier AU - Ronald Dahl AU - Kenneth R. Chapman AU - Michael Rudolf AU - Rajendra Mehta AU - Peter D'Andrea AU - Hungta Chen AU - Donald Banerji Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P757.abstract N2 - IntroductionOnce-daily (OD) QVA149 is a dual bronchodilator combining the long-acting β2-agonist indacaterol (IND) and long-acting muscarinic antagonist glycopyrronium (GLY) for the treatment of COPD. Here we evaluated the safety profile of QVA149 compared with its monocomponents (IND and GLY), open-label tiotropium and salmeterol/fluticasone.MethodsThis evaluation of 6-month safety data for QVA149 consisted of data from three pivotal Phase III studies (SHINE, ILLUMINATE and ENLIGHTEN) and a safety study in Japanese patients (ARISE). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs), electrocardiograms, hematology, clinical chemistry, urinalysis, physical condition, and vital signs (pulse and blood pressure).ResultsThe table shows the summary of safety results. The overall safety profile was similar across all groups.View this table:Table. AEs, SAEs and deaths, n (%)ConclusionOnce-daily QVA149 had a good safety profile with no safety signals compared with its monocomponents IND and GLY, tiotropium, and salmeterol/fluticasone. ER -