Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence
Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence
复制标题
DOI：
10.1111/j.1464-410x.2006.06068.x
复制
发表时间：
2006-05-01
影响因子：
4.5
通讯作者：
Guan, Zhonghong
中科院分区：
文献类型：
--
作者：
Roehrborn, Claus G.;Abrams, Paul;Guan, Zhonghong
目的评价托特罗定缓释剂（ER）对膀胱过度活动症（OAB）和急迫性尿失禁（UI）男性患者客观和主观终点的疗效和耐受性。患者和方法这是一项对从参加托特罗定ER的12周、双盲、安慰剂对照试验的OAB男性患者收集的数据进行的事后分析。（4 mg，每日一次;托特罗定ER注册试验），并且包括具有尿频（>= 8次排尿/24小时）和尿急UI（>= 5次发作/周）的男性。使用7天膀胱日记评估UI发作。12周后评估患者对治疗获益的感知。结果：总共有163名OAB患者（安慰剂组，86名;托特罗定ER组，77名;平均年龄65岁）接受了评估。两个治疗组的基线人口统计学和临床特征相似。与安慰剂相比，托特罗定ER显著减少每周UI发作（中位数%变化，-71% vs-40%，P < 0.05;平均数值变化，-11.9 vs-5.9，P = 0.02）。接受托特罗定ER的男性排尿次数/24小时较少，但与安慰剂相比无显著差异（中位数%变化，-12% vs-4%，P = 0.22）。12周后，托特罗定-ER治疗的男性（63%）比安慰剂治疗的男性（46%）报告了治疗获益（P = 0.04）。最常报告的托特罗定-ER与安慰剂相关AE为口干（16% vs 7%）、便秘（4% vs 9%）、消化不良（4% vs 1%）、头晕（5% vs 1%）和嗜睡（3% vs 1%）。其中一名接受托特罗定ER的男性出现提示尿潴留的症状，导致其退出研究。没有一个人有急性尿潴留需要cathets.CONCLUSION在男性OAB和紧迫性UI，托特罗定ER耐受性良好，并显着减少发作的紧迫性UI，并提高患者的感知治疗的好处。
OBJECTIVE To evaluate the efficacy and tolerability of tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI).PATIENTS AND METHODS This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of tolterodine ER (4 mg once daily; tolterodine ER registration trial) and included men with urinary frequency (>= 8 micturitions/24 h) and urgency UI (>= 5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. verse events (AEs) were recorded throughout the study.RESULTS In all, 163 men with OAB (placebo, 86; tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, tolterodine ER significantly reduced weekly UI episodes (median % change, -71% vs -40%, P < 0.05; mean numeric change, -11.9 vs -5.9, P = 0.02). Men receiving tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, -12% vs -4%, P = 0.22). Significantly more men treated with tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization.CONCLUSION In men with OAB and urgency UI, tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.