SESSION TITLE: COPD Safety of Treatment Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
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 µg QD via Respimat®, formoterol 12 μg 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.
CLINICAL IMPLICATIONS: In patients relevant to clinical practice, olodaterol 5 and 10 µg QD demonstrated a satisfactory cardiovascular safety profile, comparable to formoterol BID and placebo. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Paul Sachs: Consultant fee, speaker bureau, advisory committee, etc.: Boerhinger-Ingelheim Speakers Bureau Gary Ferguson: Grant monies (from industry related sources): Institution received grant money from PRISM, Other: Insitution received money from PRISM in return for Gary Ferguson's cosulting work as a coordinating investigator Alan Hamilton: Employee: Boehringer Ingelheim Kay Tetzlaff: Employee: Boehringer Ingelheim Lawrence Korducki: Employee: Boehringer Ingelheim Andrea Koch: Fiduciary position (of any organization, association, society, etc, other than ACCP: German Atemwegsliga, German Society of Pneumology (DGP), Other: Money received in return for expert testimony for Boehringer Ingelheim, Germany, Berlin-Chemie, GlaxoSmithKline,, Grant monies (from industry related sources): MSD, Boehringer Ingelheim, Actelion, Bayer, Other: Travel and acommodation expenses received for activities carried out on behalf of Boehringer Ingelheim Germany,
Submitted to regulatory authority for marketing approval