Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial.
ABSTRACT An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg trospium chloride once daily.
Subjects with overactive bladder were randomized 1:1 to receive 60 mg trospium chloride once daily or placebo in this 12-week multicenter, parallel, double-blind, placebo controlled trial. Primary end points were calculated changes in diary recorded daily urinary frequency and daily urgency urinary incontinence episodes. Secondary end points were urgency severity, volume voided per void and the number of urgency voids per day. Safety was assessed by clinical examination, adverse event monitoring, clinical laboratory values and resting electrocardiograms.
Overall 601 subjects were prescribed trospium once daily (298) or placebo (303). Trospium once daily treatment resulted in significant improvements over placebo in all primary and key secondary efficacy outcomes at weeks 1 through 12. The most common adverse events were dry mouth (trospium 8.7% vs placebo 3%) and constipation (trospium 9.4% vs placebo 1.3%). Central nervous system adverse events were rare (headache with trospium 1.0% vs placebo 2.6%). No clinically meaningful changes in laboratory, physical examination or electrocardiogram parameters were noted.
Trospium once daily provided significant improvements in overactive bladder symptoms (frequency, urgency urinary incontinence and urgency). Efficacy was similar to that seen previously with trospium chloride twice daily, while class effect anticholinergic adverse events occurred at comparatively low levels. Dry mouth was elicited at the lowest reported rate in the oral antimuscarinic drug class.
- Journal of Medical Economics 11/2012; 15(s1).
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ABSTRACT: The International Continence Society definition of overactive bladder syndrome (OAB) is “urgency, with or without urge incontinence, usually with frequency and nocturia.” OAB syndrome is a very common condition, estimated to affect 12% to 22% of women and men in Europe and 16% to 17% in the United States. The muscarinic receptor antagonists are first-line pharmacotherapy in treatment of OAB. In North America, six antimuscarinic drugs are marketed for treating OAB: oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. In our review, we summarize the pharmacology, efficacy, and adverse events of commonly used anticholinergic agents.Current Bladder Dysfunction Reports 7(1).
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ABSTRACT: Overactive bladder (OAB) treatment guidelines recommend antimuscarinics as ﬁrst-line pharmacologic therapy. Mirabegron is a first-in-class β3-adrenoceptor agonist licensed for the treatment of OAB and has shown to be well tolerated and effective in the treatment of OAB symptoms. To assess the relative efficacy and tolerability of OAB medications, specifically mirabegron 50mg versus antimuscarinics in patients with OAB. A systematic literature search was performed on published peer-reviewed articles from 2000 to 2013. This review included randomised controlled trials (RCTs) studying changes in symptoms (micturition frequency, incontinence, and urgency urinary incontinence [UUI] episodes) and incidence of the most frequently reported adverse events (dry mouth, constipation) associated with current OAB medications. The following drugs were considered in addition to mirabegron: darifenacin, tolterodine immediate release (IR) and extended release (ER), oxybutynin IR/ER, trospium, solifenacin, and fesoterodine. Bayesian mixed treatment comparisons (MTCs) were performed for efficacy (micturition, incontinence, UUI) and tolerability (dry mouth, constipation, blurred vision). Overall, 44 RCTs involving 27 309 patients were included. The MTCs showed that mirabegron 50mg was as efficacious as antimuscarinics in reducing the frequency of micturition incontinence and UUI episodes, with the exception of solifenacin 10mg that was more efficacious than mirabegron 50mg in improving micturition frequency and frequency of UUI. Mirabegron 50mg had an incidence of dry mouth similar to placebo and significantly lower than all included antimuscarinics. Mirabegron 50mg had similar efficacy to most antimuscarinics and lower incidence of dry mouth, the most common adverse event reported with antimuscarinics and one of the main causes of discontinuation of treatment. Despite being a powerful tool for evidence-based health care evaluation, the Bayesian MTC method has limitations. Further head-to-head comparisons between mirabegron and antimuscarinics should be conducted to confirm our results.European Urology 11/2013; · 10.48 Impact Factor