托特罗定缓释片每日一次治疗男性膀胱过度活动症的安全性和疗效。

Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder.

机构信息

Alliance Urology Specialists, Greensboro, North Carolina 27403, USA.

出版信息

Urology. 2011 Jan;77(1):24-9. doi: 10.1016/j.urology.2010.07.469. Epub 2010 Oct 23.

DOI:10.1016/j.urology.2010.07.469

PMID:20970833

Abstract

OBJECTIVES

This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB).

METHODS

A subgroup analysis was performed on data from the 176 male patients (trospium XR, 94; placebo, 82) who participated in 1 of the 2 studies. Patients received either trospium XR 60 mg or placebo once daily for 12 weeks.

RESULTS

The mean age was 66.2 years for trospium XR and 63.1 years for placebo. A history of benign prostatic hyperplasia was recorded for 29 trospium XR recipients (30.9%) and 23 placebo recipients (28.0%). A total of 19 patients (20.2%) receiving trospium XR and 15 (18.3%) receiving placebo experienced ≥1 treatment-emergent adverse event considered at least possibly related to the study medication. Two trospium XR patients (2.1%) developed urinary retention; both were aged ≥75 years, and 1 had a history of prostate enlargement. Treatment with trospium XR compared with placebo resulted in significantly greater decreases from baseline in the mean number of daily toilet voids (-2.5 vs -1.5; P < .05) and urgency urinary incontinence episodes (-2.3 vs -1.4; P < .05) in men at week 12 (the coprimary efficacy variables).

CONCLUSIONS

Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection.

摘要

目的

本研究使用来自 2 项大型、3 期、双盲、随机、安慰剂对照研究的汇总数据，对托特罗定缓释片（XR）治疗男性膀胱过度活动症（OAB）的安全性和疗效进行亚组分析。

方法

对参加其中 2 项研究的 176 例男性患者（托特罗定 XR 组 94 例，安慰剂组 82 例）的数据进行了亚组分析。患者接受托特罗定 XR 60mg 或安慰剂，每日 1 次，治疗 12 周。

结果

托特罗定 XR 组和安慰剂组患者的平均年龄分别为 66.2 岁和 63.1 岁。29 例托特罗定 XR 组患者（30.9%）和 23 例安慰剂组患者（28.0%）有良性前列腺增生病史。共有 19 例（20.2%）接受托特罗定 XR 治疗的患者和 15 例（18.3%）接受安慰剂治疗的患者发生了≥1 次治疗中出现的不良事件，被认为至少与研究药物有关。2 例托特罗定 XR 患者（2.1%）发生尿潴留；2 例患者年龄均≥75 岁，其中 1 例有前列腺增大病史。与安慰剂相比，托特罗定 XR 治疗可显著降低男性患者的平均每日排尿次数（从基线下降 2.5 次 vs 1.5 次；P<0.05）和急迫性尿失禁发作次数（从基线下降 2.3 次 vs 1.4 次；P<0.05），在第 12 周时达到主要疗效终点。