Cardiovascular safety of mirabegron: analysis of an integrated clinical trial database of patients with overactive bladder syndrome |
| |
Authors: | William B. White Emad Siddiqui Tri Tat Billy Franks Carol R. Schermer |
| |
Affiliation: | 1. Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA;2. Astellas Pharma Europe Ltd., Chertsey, Surrey, UK;3. Chiltern International, Slough, Berkshire, UK;4. Astellas Pharma Global Development, Inc., Northbrook, IL, USA |
| |
Abstract: | Mirabegron is a β3-adrenoreceptor agonist used for the treatment of overactive bladder syndrome. We evaluated the cardiovascular (CV) safety of mirabegron using pooled data from 13 studies. The analysis included 13,396 patients who received ≥1 dose of mirabegron (25 mg/50 mg) or comparator antimuscarinics (solifenacin 2.5 mg/5 mg/10 mg or tolterodine extended release 4 mg) as monotherapies, or placebo. We focused on changes in blood pressure and CV adverse events. Baseline CV risk factors had an imbalanced effect on subsequent CV adverse events. The frequency of these adverse events was comparable for overactive bladder treatments (0.4%–1.5%) and placebo (0.9%). Changes from baseline in blood pressure were similar for the overactive bladder treatments and placebo, and did not confer increased risk of CV adverse events. Multivariate analyses demonstrated that baseline CV risk factors (history of arrhythmia, history of coronary artery disease, and history of stroke/transient ischemic attack) were significantly associated with subsequent CV adverse events in the trials, whereas overactive bladder therapies were not. In conclusion, using an analytical approach to carefully control for CV characteristics of patients in these trials demonstrated no evidence of increased CV risk for mirabegron or antimuscarinics over placebo in the treatment of overactive bladder syndrome. |
| |
Keywords: | Cardiovascular safety hypertension mirabegron overactive bladder syndrome |
本文献已被 ScienceDirect 等数据库收录! |
|