Safety of tiotropium in patients with cardiac events in the TIOSPIR™ trial

Abstract

Background: The TIOtropium Safety and Performance In Respimat ® (TIOSPIR™) trial showed that tiotropium delivered with the Respimat Soft Mist™ Inhaler (SMI) 5µg is as safe as delivered with the HandiHaler ® device 18µg in a wide range of patients including those with concomitant cardiac disease. However, patients with several recent severe cardiac diseases (myocardial infarction [MI], heart failure, or arrhythmia) were excluded from the trial. Aims: To evaluate the safety of tiotropium Respimatafter a cardiac event. Methods: All-cause mortality, major adverse cardiovascular events (MACE) including deaths due to MACE, were analyzed post hoc in patients who remained on blinded treatment following an initial cardiac event (MI, heart failure or arrhythmia) during TIOSPIR. Results: The same number of patients experienced a cardiac event during the examined trial period (randomization to end of treatment +30 days) in the Respimat (n/N=221/5705) and HandiHaler groups (n/N=221/5687). Of those, 174 patients on Respimat remained on blinded treatment and 178 on HandiHaler. The risk of death and MACE including deaths due to MACE was similar between groups after an on treatment cardiac event (Table). Conclusions: Safety profiles of tiotropium Respimat 5µg and HandiHaler 18µg were similar in patients with chronic obstructive pulmonary disease who had an initial cardiac event during the trial; however the number of patients with events was low.