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Fesoterodine for overactive bladder: A review of the literature

机译:非索罗定治疗膀胱过度活动症:文献综述

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摘要

>Background: Overactive bladder (OAB) is a chronic condition affecting both men and women, with prevalence increasing with age. Antimuscarinics form the cornerstone of treatment of OAB. Fesoterodine, a nonselective muscarinic-receptor antagonist, was approved by the US Food and Drug Administration in late 2008 for once daily, oral administration in the treatment of OAB to relieve the symptoms of urinary urge incontinence, urgency, and frequency.>Objective: The aim of this review was to provide an overview of the mechanism of action of and clinical trial data for fesoterodine, and to discuss the present status of fesoterodine in the management of OAB.>Methods: The MEDLINE and Google Scholar databases were searched (June 1, 1999–December 1, 2009) using the terms fesoterodine, overactive bladder, and muscarinic antagonists. Full-text articles in English were selected for reference, and articles presenting the mechanism of action, pharmacokinetics, and data from clinical trials were included. The parameters measured were tolerability, efficacy, and health-related quality of life (HRQoL). Trials involving animals and Phase I studies were excluded.>Results: The initial literature search yielded 48 papers. A total of 20 articles fulfilled the inclusion criteria. In two 12-week, randomized, multicenter, Phase III clinical trials involving patients with increased micturition frequency and urgency and/or urinary urge incontinence (n = 836 and 1132 in each trial), both fesoterodine 4 and 8 mg were associated with significantly improved symptoms of OAB (frequency of micturition, urgency, and urge incontinence) compared with placebo (P < 0.05). In a post hoc analysis of pooled data of the Phase III trials, HRQoL improved significantly with both doses. In a 12-week, Phase Illb trial, fesoterodine 4 and 8 mg led to treatment satisfaction in ∼80% of patients (of 516 enrolled) who were initially unsatisfied with their previous treatment.>Conclusion: A review of the literature suggests that fesoterodine is an efficacious and well-tolerated treatment option for patients with OAB.
机译:>背景:膀胱过度活动症(OAB)是一种慢性病,影响男性和女性,患病率随年龄增长而增加。抗毒蕈碱药是OAB治疗的基石。非选择性毒蕈碱受体拮抗剂非索罗定在2008年底获得美国食品和药物管理局的批准,每天口服一次,用于治疗OAB,以减轻尿急性尿失禁,尿急和尿频的症状。>目的:这篇综述的目的是概述非索罗定的作用机理和临床试验数据,并讨论非索罗定在OAB管理中的现状。>方法:使用非索罗定,膀胱过度活动症和毒蕈碱拮抗剂等术语搜索MEDLINE和Google Scholar数据库(1999年6月1日至2009年12月1日)。选择英文全文文章作为参考,并包括介绍作用机理,药代动力学和临床试验数据的文章。测得的参数是耐受性,功效和与健康相关的生活质量(HRQoL)。 >结果:初步的文献搜索产生了48篇论文。共有20篇文章符合纳入标准。在两项12周,随机,多中心,III期临床试验中,涉及排尿频率增加和尿急和/或尿急迫性尿失禁的患者(每个试验分别为836和1132),非索罗定4 mg和8 mg均显着改善OAB症状(排尿频率,尿急和急迫性尿失禁)与安慰剂相比(P <0.05)。在对III期临床试验汇总数据进行事后分析中,两种剂量的HRQoL均显着改善。在一项为期12周的IIlb期临床试验中,非索罗定4和8 mg使最初对以前的治疗不满意的患者(约516名)中约80%的患者获得了治疗满意度。>结论:大量文献表明,非索罗定是OAB患者的一种有效且耐受良好的治疗选择。

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