Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia
Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia
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DOI：
10.1016/j.urology.2006.03.006
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发表时间：
2006-08-01
期刊：
影响因子：
2.1
通讯作者：
Guan, Zhonghong
中科院分区：
文献类型：
--
作者：
Kaplan, Steven A.;Roehrborn, Claus G.;Guan, Zhonghong
目标。评价夜间给药托特罗定缓释（TER）治疗膀胱过动症（OAB）伴夜尿症的疗效和安全性。这是对两项为期12周、双盲、安慰剂对照的夜间（睡前< 4小时）TER（每日4mg）剂量试验数据的事后分析。24小时内平均排尿次数为8次或以上，包括平均夜尿次数为2.5次或以上的男性被纳入研究。对于每次排尿，患者使用7天日记记录尿急程度，并以5分尿急等级量表（1、无；2、轻度；3、中度；4、重度；5、急迫性尿失禁）进行评分。根据尿频紧急程度分类：完全尿频（1 ~ 5）、非尿频（1 ~ 2）、尿频（3 ~ 5）和严重尿频（4 ~ 5）。在整个研究过程中记录了不良事件。共有745名男性（平均年龄64岁）被随机分配到安慰剂组（n = 374）或TER组（n = 371）。在745名男性中，73%的人报告在基线的7天日记中没有尿失禁发作。在第12周，与安慰剂组相比，TER组夜间严重OAB排尿、24小时和白天总排尿、OAB和严重OAB排尿的周值显著降低。与安慰剂相比，接受ter治疗的男性也报告了平均紧急程度的显著降低。TER相关的不良事件较低，与安慰剂组相当，但口干除外（11%对4%）。因不良事件而停药的病例很少（3% TER， 4%安慰剂）。5名男性因尿潴留症状被停药（3例TER， 2例安慰剂）。夜间给药TER可减少尿频，对OAB和夜尿症患者耐受性良好。
Objectives. To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release (TER) in men with overactive bladder (OAB) and nocturia.Methods. This was a post hoc analysis of data from two 12-week, double-blind, placebo-controlled trials of nighttime (< 4 hours before bedtime) TER (4 mg daily) dosing. Men with a mean micturition frequency of eight or more times in 24 hours, including a mean of 2.5 or more nocturia episodes/night, were included. For each micturition, patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale (1, none; 2, mild; 3, moderate; 4, severe; 5, urgency urinary incontinence). Micturitions were analyzed post hoc by urgency rating categories: total (1 to 5), non-OAB (1 to 2), OAB (3 to 5), and severe OAB (4 to 5). Adverse events were recorded throughout the study.Results. A total of 745 men (mean age 64 years) were randomized to placebo (n = 374) or TER (n = 371). Of the 745 men, 73% reported no incontinence episodes in a 7-day diary at baseline. At week 12, the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total, OAB, and severe OAB micturitions were significantly reduced in the TER group versus the placebo group. The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo. Adverse events associated with TER were low and comparable to those in the placebo group, with the exception of dry mouth (11% versus 4%). Withdrawals because of adverse events were infrequent (3% TER, 4% placebo). Five men were withdrawn for symptoms suggestive of urinary retention (3 TER, 2 placebo).Conclusions. Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia.