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2015 ; 16
(1
): 65
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Cardiac safety of tiotropium in patients with cardiac events: a retrospective
analysis of the UPLIFT® trial
#MMPMID26031308
Tashkin DP
; Leimer I
; Metzdorf N
; Decramer M
Respir Res
2015[Jun]; 16
(1
): 65
PMID26031308
show ga
BACKGROUND: Tiotropium 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, we re-evaluated the safety of tiotropium HandiHaler® in patients who
experienced recent myocardial infarction (MI), heart failure or unstable rhythm
disorder during the study. METHODS: A post-hoc analysis of all-cause mortality
and serious cardiac adverse events (cardiac SAEs), including cardiac deaths and
death unknown, was conducted in patients who had experienced cardiac arrhythmia,
MI or cardiac failure during UPLIFT® and who completed the study. Descriptive
analyses were performed. RESULTS: 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 cardiac SAEs 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 cardiac SAEs 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
cardiac SAEs compared with placebo. CONCLUSIONS: Risk of cardiac events,
mortality or SAEs 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.
|Bronchodilator Agents/adverse effects/*therapeutic use
[MESH]