SESSION TITLE: COPD Posters IV
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Monitoring cardiovascular safety is of importance when combining long-acting β2 agonists (LABA) and long-acting muscarinic antagonists (LAMA) (Tashkin et al. Respir Res. 2013; 14:49). Here, we analyze data from the FLIGHT1 and FLIGHT2 studies to assess the cardiovascular safety profile of QVA149 (a fixed-dose combination of LABA, indacaterol [IND] and LAMA, glycopyrronium [GLY]) versus its monocomponents (IND and GLY) and placebo.
METHODS: FLIGHT1 and FLIGHT2 were replicate, 12-week, multi-center, double-blind, parallel-group, placebo- and active-controlled studies that randomized patients with moderate‑to‑severe COPD (1:1:1:1) to twice daily QVA149 (IND/ GLY 27.5/12.5 μg), IND (27.5 μg), GLY (12.5 μg) or placebo. Cardiovascular safety of IND/GLY versus all treatment arms was assessed by recording all major adverse cardiovascular events (MACE) and/or cardiovascular deaths during the study.
RESULTS: Overall 2040 patients were included in the safety evaluation (IND/GLY, n=508; IND, n=511; GLY, n=513; placebo, n=508). The occurrence of MACE and/or cardiovascular deaths was <1% in all the active treatments and placebo treated group. No fatal MACE or CV death (IND/GLY, n=0; IND, n=1; GLY, n=1; placebo, n=1) was observed in the IND/GLY treatment group.
CONCLUSIONS: Overall major adverse cardiovascular events with IND/GLY were extremely low and comparable with its mono-components and placebo, reconfirming the safe use of the twice daily, fixed-dose combination, IND/GLY in patients with moderate‑to‑ severe COPD.
CLINICAL IMPLICATIONS: The safety findings support the use of IND/GLY as a maintenance bronchodilator treatment option in patients with moderate‑to‑severe COPD in the U.S.
DISCLOSURE: Robert Fogel: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Tim Ayers: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Samopriyo Maitra: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Agnes Annette Schubert-Tennigkeit: Employee: Employee of the study sponsor company (Novartis) and no other conflicts. Donald Banerji: Employee: Employee of the study sponsor company (Novartis) and no other conflicts.
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