Wagg Adrian, Cardozo Linda, Nitti Victor W, Castro-Diaz David, Auerbach Stephen, Blauwet Mary Beth, Siddiqui Emad
Department of Geriatric Medicine, University of Alberta, Alberta, Canada.
Department of Urogynaecology, Kings College London, London, UK.
Age Ageing. 2014 Sep;43(5):666-75. doi: 10.1093/ageing/afu017. Epub 2014 Mar 6.
mirabegron is a β3-adrenoceptor agonist developed for the treatment of symptoms of overactive bladder (OAB). As the prevalence of OAB increases with age, a prospective subanalysis of individual and pooled efficacy and tolerability data from three 12-week, randomised, Phase III trials, and of tolerability data from a 1-year safety trial were conducted in order to evaluate the efficacy and tolerability of mirabegron in subgroups of patients aged ≥65 and ≥75 years.
primary efficacy outcomes were change from baseline to final visit in the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h. Tolerability was assessed by the incidence of treatment-emergent adverse events (TEAEs).
over 12 weeks mirabegron 25 mg and 50 mg once-daily reduced the mean numbers of incontinence episodes and micturitions/24 h from baseline to final visit in patients aged ≥65 and ≥75 years. Mirabegron was well tolerated: in both age groups, hypertension and urinary tract infection were among the most common TEAEs over 12 weeks and 1 year. The incidence of dry mouth, a typical anticholinergic TEAE, was up to sixfold higher among the older patients randomised to tolterodine than any dose of mirabegron.
these analyses have demonstrated the efficacy of mirabegron over 12 weeks and the tolerability of mirabegron over 12 weeks and 1 year in OAB patients aged ≥65 and ≥75 years, supporting mirabegron as a therapeutic option in older patients with OAB.
米拉贝隆是一种用于治疗膀胱过度活动症（OAB）症状的β3肾上腺素能受体激动剂。由于OAB的患病率随年龄增长而增加，因此进行了一项前瞻性亚分析，以评估米拉贝隆在≥65岁和≥75岁患者亚组中的疗效和耐受性，该分析基于三项为期12周的随机III期试验的个体和汇总疗效及耐受性数据，以及一项为期1年的安全性试验的耐受性数据。
主要疗效指标为从基线到末次访视时每24小时尿失禁发作的平均次数和每24小时排尿的平均次数。通过治疗中出现的不良事件（TEAE）发生率评估耐受性。
在12周内，每日一次服用25mg和50mg米拉贝隆可使≥65岁和≥75岁患者从基线到末次访视时每24小时尿失禁发作和排尿的平均次数减少。米拉贝隆耐受性良好：在两个年龄组中，高血压和尿路感染是12周和1年期间最常见的TEAE。在随机接受托特罗定治疗的老年患者中，口干（一种典型的抗胆碱能TEAE）的发生率比任何剂量的米拉贝隆高出多达六倍。
这些分析证明了米拉贝隆在12周内对≥65岁和≥75岁的OAB患者的疗效，以及在12周和1年期间的耐受性，支持米拉贝隆作为老年OAB患者的一种治疗选择。
