PURPOSE: The novel LABA olodaterol has shown an acceptable safety profile in individual Phase III studies. The cardiovascular safety of olodaterol was evaluated in a pooled analysis of adverse event (AE) and ECG data from all the pivotal long‐term studies. METHODS: Four randomized, double‐blind, placebo‐controlled, parallel‐group studies (NCT00782210; NCT00782509; NCT00793624; NCT00796653) investigated olodaterol 5 or 10 mug QD via Respimat, formoterol 12 mug BID via Aerolizer (NCT00793624 and NCT00796653), or placebo for 48 weeks. AEs, serious AEs (SAEs), and major adverse cardiovascular events (MACE) were evaluated using MedDRA system organ class, preferred terms, and aggregate pharmacovigilance terms. ECG data were evaluated for the presence of conduction changes or arrhythmias, with Holter‐ECG available for a subgroup of 775 patients. Subgroups of patients with a history of cardiac disease or beta‐blocker use were compared to those without such history or co‐medication. RESULTS: Overall, the incidences of cardiac and vascular AEs were balanced across treatments in the 3104 patients studied, ranging from 5.7‐7.9% and 3.9‐5.7%, respectively. SAEs were reported infrequently, with atrial fibrillation slightly higher in olodaterol‐treated patients (0.6% for both doses versus 0.3% placebo and 0.2% formoterol). MACE were more frequently reported in placebo‐treated patients. There were no dose‐ or time‐related trends for any ECG abnormalities, and Holter evaluations did not reveal any clinically significant findings. Subgroup analyses revealed no increased risk for olodaterol‐treated patients versus placebo in cardiac or vascular AEs. MACE were balanced across treatments in the subgroup of patients with a history of cardiac disease. CONCLUSIONS: Olodaterol showed a satisfactory cardiovascular safety profile in a broad population of patients with GOLD 2‐4 COPD. There were no differences in AE frequency across treatments in subgroups of patients with cardiac history or beta‐blocker use.
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Sachs, P., Ferguson, G., Hamilton, A., Tetzlaff, K., Korducki, L., & Koch, A. (2013). Pooled Cardiac Safety Analysis of 48-Week Administration of Olodaterol Once Daily (QD) via Respimat ® Versus Placebo and Formoterol Twice Daily (BID) in Patients With COPD. Chest, 144(4), 713A. https://doi.org/10.1378/chest.1702141