Peter K Sand, Roger R Dmochowski, Norman R Zinner, David R Staskin, Rodney A Appell
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引用次数: 24
Abstract
Introduction and hypothesis: To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.
Methods: Adults (aged > or = 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505). Endpoints examined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance.
Results: At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P < 0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%).
Conclusions: Trospium ER was effective and well tolerated in women with OAB.
前言和假设:为了证实缓释(ER)氯曲索铵对女性膀胱过度活动综合征(OAB)的疗效和耐受性，我们分析了两项相同的III期研究的数据。方法:有尿急、尿频和急迫性尿失禁(UUI)的OAB成人(年龄>或= 18岁)被随机分配至trospium ER 60mg或安慰剂组，每天1次，持续12周。分析纳入989名女性(trospium ER, n = 484;安慰剂，n = 505)。研究的终点包括第12周排便次数和UUI发作/天的基线变化。连续资料采用秩方差分析进行分析。结果:在第12周，与安慰剂相比，口服曲spium ER的平均排便次数和UUI发作次数的减少明显更大(P < 0.0001)。不良事件被认为至少可能与trospium ER治疗相关，包括口干(11.4%)和便秘(8.9%)。结论:Trospium ER对OAB女性有效且耐受性良好。
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