Kato Daisuke, Tabuchi Hiromi, Uno Satoshi
Medical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
Medical Research, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
Low Urin Tract Symptoms. 2019 Jan;11(1):14-23. doi: 10.1111/luts.12188. Epub 2017 Aug 1.
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).
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.
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).
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.
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。
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。
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)。
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。