Cardiovascular (CV) safety of indacaterol/glycopyrronium (IND/GLY) compared with salmeterol/fluticasone combination (SFC) in moderate-to-very severe COPD patients with prior exacerbations: The FLAME study

Introduction LABA/ ICS combination and/or LAMA are recommended as the first-choice of treatment for COPD patients (pts) with high exacerbation risk [GOLD 2016]. The FLAME study compared the effect of IND/GLY vs SFC on exacerbations in COPD pts at future risk of exacerbations. As these pts are also at risk for CV complications, here we present the CV safety of IND/GLY vs SFC from the FLAME study. Methods In this 52-week multi-centre double-blind study, pts with moderate-to-very severe COPD (post-bronchodilator FEV 1 predicted ≥25– Results In total, 3362 pts were randomised (1:1), of whom 3358 were included in the safety set. The occurrence of new onset atrial fibrillation/flutter (IND/GLY, 0.4%; SFC, 0.5%) and non-fatal MACE (IND/GLY, 1.4%; SFC, 1.3%) was similar in both treatment arms. No clinically meaningful differences were observed in ECG and vital signs [newly occurring or worsening QTcF values: u003e450ms (IND/GLY, 8.9%; SFC, 6.7%); u003e480ms (IND/GLY, 0.5%; SFC, 0.4%); u003e500ms (IND/GLY,0; SFC,0) and increase in QTcF of u003e60ms from baseline (IND/GLY, 0.5%; SFC, 0.3%)]. Overall, 20 adjudicated CV deaths occurred (IND/GLY, 9 [0.5%]; SFC, 11 [0.7%]). Conclusions IND/GLY has a favorable cardiovascular safety and tolerability profile, similar to SFC, in exacerbating pts with moderate-to-very severe COPD.