BACKGROUND The majority of patients with overactive bladder (OAB) are aged >65yr. There has been no prospectively designed study assessing treatment efficacy with the β3-adrenoreceptor agonist, mirabegron, specifically in this age group. OBJECTIVE A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. DESIGN, SETTING, AND PARTICIPANTS Community-dwelling patients aged ≥65yr with OAB for ≥3mo. INTERVENTION Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24h were randomised 1:1 to double-blind 25mg/d mirabegron or matched placebo, for 12wk. After week 4 or 8, the dose could be increased to 50mg/d mirabegron/matched placebo based on patient and investigator discretion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24h and incontinence episodes/24h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24h, mean volume voided/micturition, and mean number of urgency episodes/24h. Stratified rank ANCOVA was used for the mean numbers of incontinence episodes/24h and urgency incontinence episodes/24h. RESULTS AND LIMITATIONS Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Safety and tolerability were consistent with the known mirabegron safety profile. CONCLUSIONS Mirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65yr with OAB and incontinence. PATIENT SUMMARY We examined the effect of mirabegron compared with placebo in people aged 65yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron.

中文翻译：

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米拉贝隆在≥65岁的膀胱过度活动症患者中的疗效，安全性和耐受性：一项IV期，双盲，随机，安慰剂对照研究（PILLAR）。

背景技术大多数膀胱过度活动症（OAB）患者的年龄均大于65岁。尚无前瞻性设计的研究评估β3-肾上腺素受体激动剂米拉贝隆的治疗效果，特别是在该年龄组。目的一项IV期研究比较软性米拉贝隆与安慰剂对老年OAB和尿急性尿失禁患者的作用。设计，地点和参与者≥65岁且OAB≥3mo的社区居住患者。干预2周安慰剂运行后，将有一个或多个失禁发作，三个或以上尿急发作，平均8个以上排尿/ 24h的患者按1：1随机分配25mg / d米拉贝隆或配对安慰剂双盲，适用于12周。在第4周或第8周后，根据患者和研究者的判断，剂量可以增加至50mg / d米拉贝隆/匹配的安慰剂。结果测量和统计分析主要终点：从基线到治疗结束（EOT）的平均排尿次数/ 24h和失禁发作/ 24h。次要终点：从基线到EOT的平均排尿量/排尿次数，平均尿急发作次数/ 24h和平均尿急尿失禁次数/ 24h。协方差分析（ANCOVA）用于平均排尿次数/ 24h，平均排尿量/排尿次数和平均尿急发作次数/ 24h。分层等级ANCOVA用于尿失禁发作/ 24h和尿急尿失禁发作/ 24h的平均数。结果与局限性观察到米拉贝隆组与安慰剂组相比，从基线到EOT的平均排尿次数/ 24h变化有统计学上的显着改善，平均尿失禁发作次数/ 24h，平均排尿量/排尿次数，平均尿急发作次数/ 24h和平均尿急尿失禁发作次数/ 24h。安全性和耐受性与已知的米拉贝隆安全特性一致。结论在≥65岁的OAB和尿失禁患者中，证实Mirabegron的疗效，安全性和耐受性超过12周。病人总结我们检查了米拉贝隆与安慰剂相比对65岁或以上膀胱过度活动和尿失禁患者的作用。与安慰剂相比，Mirabegron改善了膀胱过度活动症的症状。副作用类似于米拉贝隆已知的副作用。安全性和耐受性与已知的米拉贝隆安全特性一致。结论在≥65岁的OAB和尿失禁患者中，证实Mirabegron的疗效，安全性和耐受性超过12周。病人总结我们检查了米拉贝隆与安慰剂相比对65岁或以上膀胱过度活动和尿失禁患者的作用。与安慰剂相比，Mirabegron改善了膀胱过度活动症的症状。副作用类似于米拉贝隆已知的那些。安全性和耐受性与已知的米拉贝隆安全特性一致。结论在≥65岁的OAB和尿失禁患者中，证实Mirabegron的疗效，安全性和耐受性超过12周。病人总结我们检查了米拉贝隆与安慰剂相比对65岁或以上膀胱过度活动和尿失禁患者的作用。与安慰剂相比，Mirabegron改善了膀胱过度活动症的症状。副作用类似于米拉贝隆已知的副作用。与安慰剂相比，Mirabegron改善了膀胱过度活动症的症状。副作用类似于米拉贝隆已知的那些。与安慰剂相比，Mirabegron改善了膀胱过度活动症的症状。副作用类似于米拉贝隆已知的副作用。