Department of Urology, University of Yamanashi Graduate School of Medical Sciences, 1110 Shimokato, Chuo City, Yamanashi, 409-3898, Japan.
BMC Urol. 2022 Mar 21;22(1):40. doi: 10.1186/s12894-022-00989-7.
We assessed the efficacy and safety of mirabegron, a β-adrenoceptor agonist, in older adults (≥ 80 years old) with overactive bladder (OAB).
OAB patients aged ≥ 80 years were enrolled in this prospective, single-arm observational study. OAB was diagnosed based on the OAB symptom score (OABSS); i.e., a total score of ≥ 3 points and an urgency score of ≥ 2 points. Patients who received 50 mg mirabegron once daily were evaluated at the baseline and at 4, 8, and 12 weeks. The changes from the baseline in the OABSS, International Prostate Symptom Score (IPSS), OAB questionnaire (OAB-q) score, and Vulnerable Elders Survey (VES-13) score were determined. Adverse events, laboratory tests, 12-lead electrocardiography, the QT interval according to Fridericia's formula (QTcF), uroflowmetry, the post-void residual urine volume (PVR), and the Mini-Mental State Examination (MMSE) score were used to assess safety.
Forty-three patients (median age: 84 years, range: 80-96 years) were examined. They had high rates of comorbidities and polypharmacy. Mirabegron significantly improved in total score of the OABSS, including urgency and urge incontinence. The total IPSS, IPSS quality-of-life (QOL) index, and OAB-q scores also significantly improved. Mirabegron improved in the VES-13 score. There were no significant changes in laboratory test values, uroflowmetry findings, PVR, the QTcF, or MMSE score. Two patients (4.7%) withdrew from the study after experiencing adverse events.
Mirabegron was well tolerated and significantly improved in OAB symptoms, and QOL in older patients. Trial registration The present clinical study was approved by University of Yamanashi Institutional Review Board prior to study initiation (ID1447) and was retrospectively registered with the UMIN Clinical Trials Registry (UMIN-CTR), Japan (UMIN000045996) on Nov 6, 2021.
我们评估了米拉贝隆（一种β-肾上腺素能受体激动剂）在≥80 岁的膀胱过度活动症（OAB）患者中的疗效和安全性。
本前瞻性、单臂观察性研究纳入了≥80 岁的 OAB 患者。OAB 基于 OAB 症状评分（OABSS）进行诊断，即总分≥3 分，尿急评分≥2 分。接受每日 50mg 米拉贝隆治疗的患者在基线和第 4、8、12 周进行评估。根据基线变化，测定 OABSS、国际前列腺症状评分（IPSS）、OAB 问卷（OAB-q）评分和脆弱老年人调查（VES-13）评分。不良事件、实验室检查、12 导联心电图、根据 Fridericia 公式（QTcF）的 QT 间期、尿流率、剩余尿量（PVR）和简易精神状态检查（MMSE）评分用于评估安全性。
共检查了 43 名患者（中位年龄：84 岁，范围：80-96 岁）。他们合并症和多药治疗的发生率很高。米拉贝隆显著改善了 OABSS 的总分，包括尿急和急迫性尿失禁。总 IPSS、IPSS 生活质量（QOL）指数和 OAB-q 评分也显著改善。米拉贝隆改善了 VES-13 评分。实验室检查值、尿流率结果、PVR、QTcF 或 MMSE 评分无明显变化。两名患者（4.7%）因不良事件退出研究。
米拉贝隆在高龄患者中耐受性良好，可显著改善 OAB 症状和生活质量。
本临床研究在研究启动前获得了山梨大学机构审查委员会的批准（ID1447），并于 2021 年 11 月 6 日在日本 UMIN 临床研究注册中心（UMIN-CTR）进行了回顾性注册（UMIN000045996）。
