Introduction Patients with COPD frequently exhibit cardiovascular comorbidities and are at risk
of cardiac arrhythmias. To evaluate potential class effects of long-acting muscarinic
antagonists (LAMAʼs) and long-acting β2-agonists (LABAʼs) on an increased arrhythmia
risk in COPD patients, further investigation is required.
Aims To analyse Holter ECG data from the TONADO 1 +2 studies to assess the effect of tiotropium
(5 µg)/olodaterol (5 µg) (T/O) combination therapy vs. monocomponents (Tio or Olo)
on cardiac arrhythmia endpoints.
Methods Holter ECG monitoring was performed on a subset of patients (N = 506) in two Phase
III, replicate, multicentre studies at baseline and 12 weeks. Records were evaluated
for 24-hour mean heart rate (HR), supraventricular premature beats (SVPBs) and ventricular
premature beats (VPBs).
Results No pro-arrhythmic SVPB or VPB effect was observed for T/O vs. Tio and Olo. The proportions
of patients showing a decrease, increase or no change in SVPB and VPB from baseline
was comparable across treatment groups (Figure). The change in mean HR from baseline
to Week 12 was small and not clinically relevant in all treatment groups (−0.6 for
T/O, 1.8 for Tio and 0.5 for Olo).
Conclusions Treatment with T/O combination therapy and its monocomponents is not associated with
an increased rate of arrhythmias or heart rate as assessed by Holter ECG.
