Department of Pharmacy, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.
Division of Infectious Diseases, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.
World J Urol. 2018 Aug;36(8):1285-1297. doi: 10.1007/s00345-018-2268-9. Epub 2018 Mar 19.
Mirabegron, a β3-adrenoceptor agonist, was approved for overactive bladder (OAB), but worsened hypertension was a potential risk based on its mechanism of action. Besides, head to head comparisons were limited between mirabegron and antimuscarinic agents, the prior first-line pharmacotherapy of OAB. In this regard, we performed a systematic review and meta-analysis to compare their efficacy as well as safety, especially in blood pressure changes.
Literature search was conducted in PubMed, Medline and seven randomized clinical trial (RCT) register databases of WHO, EU, USA, Taiwan, China, Japan and Cochrane. Completed RCTs for OAB with mirabegron and antimuscarinics were identified and the last comprehensive search was run in August 2017. Cochrane risk of bias tool was used to assess the potential bias, and RevMan5 software was performed for meta-analysis.
Seven eligible RCTs (four for mirabegron vs. tolterodine and three for mirabegron vs. solifenacin) were included and demonstrated similar efficacy in micturitions, incontinence, and nocturia between mirabegron and antimuscarinics. In hypertension issue, no statistical differences were showed in risk ratio (RR) of hypertension events, change of blood pressure from baseline and change of blood pressure from placebo for all participants. On the other hand, RR of dry mouth was significantly lower in mirabegron users.
Mirabegron was not inferior effective in improving OAB symptoms compared with antimuscarinic agents. In addition, mirabegron presented lower incidence of dry mouth and not higher risk for hypertension. Therefore, mirabegron has potential to be an alternative therapeutic option for OAB control.
米拉贝隆是一种β3-肾上腺素能受体激动剂,已被批准用于治疗膀胱过度活动症(OAB),但其作用机制可能导致血压升高。此外,米拉贝隆与抗毒蕈碱药物(OAB 的一线首选药物)之间的头对头比较有限。在这方面,我们进行了系统评价和荟萃分析,以比较它们的疗效和安全性,尤其是在血压变化方面。
在 PubMed、Medline 和世界卫生组织(WHO)、欧盟(EU)、美国、台湾、中国、日本和 Cochrane 的七个随机临床试验(RCT)注册数据库中进行了文献检索。确定了使用米拉贝隆和抗毒蕈碱药物治疗 OAB 的已完成 RCT,并于 2017 年 8 月进行了最后一次全面检索。使用 Cochrane 偏倚风险工具评估潜在偏倚,并使用 RevMan5 软件进行荟萃分析。
纳入了 7 项符合条件的 RCT(4 项米拉贝隆与托特罗定比较,3 项米拉贝隆与索利那新比较),结果表明米拉贝隆与抗毒蕈碱药物在排尿、失禁和夜尿方面疗效相似。在高血压问题上,米拉贝隆组和抗毒蕈碱药物组在高血压事件风险比(RR)、基线血压变化和安慰剂血压变化方面均无统计学差异。另一方面,米拉贝隆组口干的 RR 明显降低。
与抗毒蕈碱药物相比,米拉贝隆在改善 OAB 症状方面同样有效。此外,米拉贝隆口干发生率较低,高血压风险不增加。因此,米拉贝隆可能成为 OAB 治疗的一种替代选择。