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米拉贝隆对比抗胆碱能单药治疗或联合治疗用于治疗膀胱过度活动症的疗效和耐受性:一项系统评价和网络荟萃分析。

Efficacy and Tolerability of Mirabegron Compared with Antimuscarinic Monotherapy or Combination Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis.

机构信息

Guys and St Thomas' Hospital, London, UK.

Astellas Pharma Europe B.V., Leiden, The Netherlands.

出版信息

Eur Urol. 2018 Sep;74(3):324-333. doi: 10.1016/j.eururo.2018.03.020. Epub 2018 Apr 23.

DOI:10.1016/j.eururo.2018.03.020
PMID:29699858
Abstract

BACKGROUND

Mirabegron is an established treatment alternative to antimuscarinic therapy for patients with overactive bladder (OAB), as shown by efficacy and tolerability data from phase III trials.

OBJECTIVE

To assess efficacy and tolerability of mirabegron 50mg versus antimuscarinic monotherapies and combination therapies.

DESIGN, SETTING, AND PARTICIPANTS: Systematic literature review and network meta-analysis of randomised controlled trials (2000-2017) assessing eligible treatments for OAB.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Efficacy assessments included micturition frequency, urgency urinary incontinence, dry rate, and 50% reduction in incontinence. Tolerability assessments included dry mouth, constipation, blurred vision, and hypertension.

RESULTS AND LIMITATIONS

A total of 64 studies (n=46 666) were included in the network meta-analysis. Mirabegron 50mg was significantly more efficacious than placebo for all efficacy endpoints. Comparable overall efficacy was observed for mirabegron 50mg versus most active treatments, but solifenacin 10mg monotherapy and solifenacin 5mg plus mirabegron 25 or 50mg in combination were more efficacious for some/all outcomes. Mirabegron 50mg was significantly better tolerated regarding dry mouth, constipation, and urinary retention than 21/22, 9/20, and 7/10 active comparators, respectively; similar overall tolerability was observed between mirabegron 50mg and all treatments (including placebo) for the remaining endpoints. Limitations of the study included between-trial variations in the definition of certain endpoints and heterogeneity of the available data (eg, number of studies and patients assessed) for comparator treatments across different endpoints.

CONCLUSIONS

The relief of key OAB symptoms produced by mirabegron 50mg is significantly better than placebo, and similar to a range of common antimuscarinics, with the benefit of significantly fewer bothersome anticholinergic side effects such as dry mouth. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg appears to provide an efficacy benefit compared with mirabegron 50mg, with the expected side effects of individual antimuscarinics.

PATIENT SUMMARY

This study assessed the efficacy and tolerability of different drug treatments for OAB. Mirabegron 50mg was as effective as antimuscarinic therapy, with fewer common, bothersome side effects such as dry mouth, constipation, and urinary retention. Combination treatment of solifenacin 5mg plus mirabegron 25 or 50mg was more effective than mirabegron 50mg alone, but with more anticholinergic side effects.

摘要

背景

米拉贝隆是一种已被证实的治疗膀胱过度活动症(OAB)的替代药物,其疗效和耐受性数据在 III 期临床试验中得到了验证。

目的

评估米拉贝隆 50mg 与抗毒蕈碱单药治疗和联合治疗的疗效和耐受性。

设计、地点和参与者:系统文献复习和网络荟萃分析随机对照试验(2000-2017 年),评估 OAB 治疗的合格治疗方法。

结局测量和统计分析

疗效评估包括排尿频率、尿急性尿失禁、干燥率和尿失禁减少 50%。耐受性评估包括口干、便秘、视力模糊和高血压。

结果和局限性

共纳入 64 项研究(n=46666)进行网络荟萃分析。米拉贝隆 50mg 与安慰剂相比,所有疗效终点均显著更有效。米拉贝隆 50mg 与大多数活性治疗药物的总体疗效相当,但索利那新 10mg 单药治疗和索利那新 5mg 联合米拉贝隆 25 或 50mg 治疗在某些/所有结局方面更有效。米拉贝隆 50mg 治疗口干、便秘和尿潴留的耐受性显著优于 21/22、9/20 和 7/10 种活性对照药物,分别;米拉贝隆 50mg 与所有治疗方法(包括安慰剂)在其余终点的总体耐受性相似。研究的局限性包括某些终点的定义在试验之间存在差异,以及不同终点的可比治疗方法的可用数据(例如,评估的研究和患者数量)存在异质性。

结论

米拉贝隆 50mg 治疗可显著改善关键 OAB 症状,其疗效明显优于安慰剂,与一系列常见的抗毒蕈碱药物相当,同时具有明显较少的烦人的抗胆碱能副作用,如口干。与米拉贝隆 50mg 相比,索利那新 5mg 联合米拉贝隆 25 或 50mg 的联合治疗似乎具有疗效优势,同时具有个体抗毒蕈碱药物的预期副作用。

患者总结

本研究评估了不同药物治疗 OAB 的疗效和耐受性。米拉贝隆 50mg 与抗毒蕈碱治疗同样有效,且口干、便秘和尿潴留等常见、烦人的副作用较少。与米拉贝隆 50mg 单药治疗相比,索利那新 5mg 联合米拉贝隆 25 或 50mg 的联合治疗更有效,但抗胆碱能副作用更多。

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