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.

Mirabegron为β ₃-肾上腺素能受体激动剂用于治疗膀胱过度活动症。我们使用来自13项研究的汇总数据评估了米拉贝隆的心血管（CV）安全性。该分析包括13,396例患者，这些患者接受了≥1剂量的米拉贝隆（25 mg / 50 mg）或比较药物抗毒蕈碱药（索非那新2.5 mg / 5 mg / 10 mg或托特罗定缓释4 mg）作为单一疗法或安慰剂。我们专注于血压和CV不良事件的变化。基线心血管危险因素对随后的心血管不良事件影响不平衡。这些不良事件的发生率与膀胱过度活跃症治疗（0.4％–1.5％）和安慰剂治疗（0.9％）相当。对于过度活跃的膀胱治疗和安慰剂，血压从基线的变化是相似的，并且不会增加CV不良事件的风险。多变量分析表明，基线CV危险因素（心律失常史，冠状动脉疾病史和中风/短暂性脑缺血发作史）与随后的CV不良事件显着相关，而膀胱过度活跃疗法则无此意义。总之，在这些试验中，使用分析方法仔细控制患者的心血管特征表明，没有证据表明在过度活跃的膀胱综合征中，米拉贝隆或抗毒蕈碱药物的心血管风险比安慰剂要高。