Effect of olodaterol once-daily on heart rate in GOLD 2 – 4 COPD patients

Introduction:

Cardiovascular (CV) comorbidities are common in COPD patients and increased heart rate reflects an increased CV risk over time. LABAs are well established treatments in patients with COPD but have the potential to increase HR.

Aim and objectives:

To report the post-hoc results of a pooled analysis of the effect of olodaterol (5 or 10 µg) or formoterol (12 µg) on heart rate in GOLD 2 – 4 COPD patients.

Methods:

Four randomised, double-blind, placebo-controlled Phase III studies were analysed (NCT00782210/NCT00782059, NCT00793624/NCT00796653). Heart rate was measured pre-dose using resting ECGs at each visit with a standardised protocol at baseline, Weeks 6, 12, 24 and 48.

Results:

There was only a small difference observed in mean heart rate change from baseline over 48 weeks (Fig). The maximum change from baseline occurred at Week 48 with an increase of 1.75 bpm, however quantitative changes were low during the study. No significant differences between treatment groups were observed at Week 48.

Fig. 1: Effect of olodaterol and formoterol on heart rate up to 48 weeks
CI = confidence interval; bpm = beats per minute; analysis is based on mixed effect model repeat measurement (MMRM model) with fixed effects to include treatment, tiotropium strata, visit, treatment by visit interaction, baseline and baseline by visit interaction

Conclusions:

No clinically relevant increase in heart rate was observed with olodaterol or formoterol maintenance treatment, underlining the CV safety of LABA therapy in COPD.

Sponsored by Boehringer Ingelheim

Previously presented at ERS 2017