Cardiovascular safety of QVA149, a combination of indacaterol and NVA237, in COPD patients

This study assessed the cardiovascular safety of QVA149, an inhaled, once daily,bronchodilator combination containing two 24-hour bronchodilators, the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium(NVA237). In this randomised, double-blind, placebo-controlled, parallel-group study,257 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)were randomised to receive QVA149 (indacaterol/NVA237) 600/100 μg, 300/100 μg or150/100 μg, indacaterol 300 μg or placebo, once daily for 14 days. The primary endpointwas change from baseline in 24-h mean heart rate versus placebo on Day 14. 255patients were included in the safety analysis (mean age 63.8 years, 76.5% male, postbronchodilatorforced expiratory volume in one second [FEV1] 53.2% predicted,FEV1/FVC [forced vital capacity] 50.0%, mean 24-h heart rate 79.6 bpm). There were noclinically significant differences in the 24-h mean heart rate on Day 14 between the threedoses of QVA149 and placebo or indacaterol. The confidence intervals of these treatmentdifferences (contrasts) were within the pre-specified equivalence limit (-5 to 5 bpm). Noclinically relevant differences in QTc interval (Fridericia's) were observed betweengroups on Days 1, 7 and 14. Once-daily QVA149 was well tolerated in COPD patientswith a cardiovascular safety profile and overall AE rates similar to placebo.Page 4 of 36URL: http:/mc.manuscriptcentral.com/copd Email: COPD@njc.orgCOPD: Journal Of Chronic Obstructive Pulmonary Disease