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在日常临床环境中米拉贝隆长期治疗膀胱过度活动症的安全性、有效性和持久性:一项日本上市后监测研究的中期(1年)报告

Safety, efficacy, and persistence of long-term mirabegron treatment for overactive bladder in the daily clinical setting: Interim (1-year) report from a Japanese post-marketing surveillance study.

作者信息

Kato Daisuke, Tabuchi Hiromi, Uno Satoshi

机构信息

Medical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.

Medical Research, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.

出版信息

Low Urin Tract Symptoms. 2019 Jan;11(1):14-23. doi: 10.1111/luts.12188. Epub 2017 Aug 1.

Abstract

OBJECTIVES

To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB).

METHODS

Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis.

RESULTS

Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3, 6 months, and 1 year, or at discontinuation (P < 0.001 at each time point). Kaplan-Meier treatment persistence rates were 84.8% at 3 months, 77.6% at 6 months, and 66.0% at 1 year. Treatment persistence rates were similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032).

CONCLUSIONS

Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years.

摘要

目的

报告一项为期3年的监测研究的1年中期结果,该研究评估了长期使用米拉贝隆治疗膀胱过度活动症(OAB)的安全性、有效性和持续性。

方法

对开始使用米拉贝隆治疗与OAB相关的尿急、日间尿频和急迫性尿失禁的患者进行登记,并随访3年。收集药物不良反应(ADR)、OAB症状变化、膀胱过度活动症症状评分(OABSS)变化及治疗中断情况的数据。通过Kaplan-Meier分析计算治疗持续率。

结果

在米拉贝隆治疗1年期间,72/1139例患者(6.3%)出现81例ADR,发生率在第一个月最高。在米拉贝隆治疗1年的任何观察点,残余尿量均未观察到显著变化。在1年/停药时,883/1091例患者(80.9%)认为米拉贝隆“有效”。在3个月、6个月、1年或停药时,总OABSS均有统计学意义的下降(各时间点P<0.001)。Kaplan-Meier治疗持续率在3个月时为84.8%,6个月时为77.6%,1年时为66.0%。男性和女性患者的治疗持续率相似,但≥65岁患者(67.3%;n=908)的治疗持续率显著高于<65岁患者(59.8%;n=231;对数秩检验:P=0.032)。

结论

长期使用米拉贝隆治疗OAB耐受性良好,有效性维持1年。米拉贝隆的治疗持续率高于先前报道,且≥65岁患者的治疗持续率高于<65岁患者。

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