Patients with cardiac events: cardiac safety of Tiotropium in a retrospective analysis of the UPLIFT
Tiotropium ( Spiriva ) is an anticholinergic bronchodilator for symptom relief and reducing exacerbations with an established safety profile in patients with chronic obstructive pulmonary disease ( COPD ).
Using data from the 4-year Understanding Potential Long-term Impacts on Function with Tiotropium ( UPLIFT ) study, researchers have re-evaluated the safety of Tiotropium HandiHaler in patients who experienced recent myocardial infarction, heart failure or unstable rhythm disorder during the study.
A post-hoc analysis of all-cause mortality and serious cardiac adverse events, including cardiac deaths and death unknown, was conducted in patients who had experienced cardiac arrhythmia, myocardial infarction or cardiac failure during UPLIFT and who completed the study.
Descriptive analyses were performed.
Most patients experiencing cardiac events, for which they would have been excluded at baseline, remained in the trial. Kaplan-Meier analyses revealed a trend to later occurrence of serious cardiac adverse events with Tiotropium HandiHaler versus placebo.
Patients who experienced a cardiac event and continued in UPLIFT were not found to be at subsequently increased risk of all-cause mortality or serious cardiac adverse effects with Tiotropium treatment.
Evaluation of deaths by major adverse cardiac events composite endpoints also showed that patients treated with Tiotropium were not at increased risk of mortality or serious cardiac adverse events compared with placebo.
In conclusion, risk of cardiac events, mortality or severe adverse reactions was not increased by Tiotropium in patients experiencing cardiac events for which they would have been excluded at study baseline.
The findings support the cardiac safety of Tiotropium HandiHaler in patients with COPD. ( Xagena )
Tashkin DP et al, Respiratory Research 2015, 16:65 doi:10.1186/s12931-015-0216-4