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 a satisfactory overall safety profile in a program of Phase III studies. Given LABA class-related safety concerns in asthma, a further specific analysis was undertaken to comprehensively and objectively evaluate the respiratory safety of olodaterol in patients with GOLD 2-4 COPD.
METHODS: An independent Adjudication Committee (blinded to treatment) evaluated all serious adverse events (SAEs) from a safety database of patients enrolled in 18 olodaterol clinical studies (15 COPD, 3 asthma) for the on-treatment incidence of a respiratory-related composite end point comprising death, hospitalization, and intubation (as well as individual components).
RESULTS: The database included 5387 patients, with 3380 receiving olodaterol (doses 2, 2.5, 5, 10, and 20 µg once daily [QD] and 2, 2.5, and 5 µg twice daily [BID]: only 5 and 10 µg QD arms with substantial exposure reported here). Studies ranged from 3-48 weeks, including active- (formoterol 12 µg BID) and placebo-controlled studies. 504 patients had adjudicated SAEs. 4.9% of patients (n=68) receiving olodaterol 5 µg QD and 5.9% (n=86) receiving olodaterol 10 µg QD experienced a respiratory-related event, versus 5.3% (n=74) with placebo and 7.2% (n=39) with formoterol. Asthma, COPD, or pneumonia-related events occurred in 62 (4.4%), 76 (5.2%), 73 (5.2%), and 36 (6.7%) patients receiving olodaterol 5 µg QD, olodaterol 10 µg QD, placebo, or formoterol, respectively.
CONCLUSIONS: The risk of respiratory-related SAEs with olodaterol 5 and 10 µg QD was similar to that of patients treated with placebo or formoterol.
CLINICAL IMPLICATIONS: The safety profile of olodaterol 5 and 10 µg QD regarding important respiratory outcomes relevant to clinical practice is satisfactory and similar to formoterol BID and placebo. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Dennis Niewoehner: Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, Novartis, Forest Research, and Gilead Lorcan McGarvey: Other: Lorcan McGarvey's institution received fees for his participation in advisory boards for Almirall, NAPP, Glaxo Smith Kline, Boehringer Ingelheim , Consultant fee, speaker bureau, advisory committee, etc.: Endpoint adjudication Committee. Served as Chairman and Committee Member. Boehringer Ingelheim, Glaxo Smith Kline, University grant monies: Chiesi, Laboratory Animal Science Association / NC3Rs, NI Chest heart & Stroke Association, Royal Belfast Hospital Sick Children Clinical Fellowship, Research Forum for the Child International PhD studentships Alan Hamilton: Employee: Boehringer Ingelheim Kay Tetzlaff: Employee: Boehringer Ingelheim Pharma GmbH & Co. KG Lawrence Korducki: Employee: Boehringer Ingelheim Pharmaceuticals Inc. Claus Vogelmeier: Consultant fee, speaker bureau, advisory committee, etc.: gave presentations at symposia and/or served on scientific advisory boards sponsored by Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Janssen, Mundipharma, Novartis, Nycomed/Takeda
Submitted to regulatory authority for marketing approval