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Trospium chloride once-daily extended release is efficacious and tolerated in elderly subjects (aged >/= 75 years) with overactive bladder syndrome.

Author(s): Sand PK, Johnson Ii TM, Rovner ES, Ellsworth PI, Oefelein MG, Staskin DR

Affiliation(s): Division of Urogynecology and Reconstructive Pelvic Surgery, NorthShore University HealthSystem, University of Chicago, Pritzker School of Medicine, Evanston, IL, USA. psand@northshore.org

Publication date & source: 2011-02, BJU Int., 107(4):612-20. Epub 2010 Aug 12.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: * To evaluate the safety and efficacy of once-daily trospium chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged >/= 75 years. SUBJECTS AND METHODS: * The analysis included subjects >/= 75 years of age with OAB. * A subgroup analysis of pooled data was performed for subjects aged >/= 75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged >/= 75 years (85 trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. * Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS: * At week 12 of the double-blind period, trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. * Efficacy and tolerability persisted among subjects receiving open-label trospium ER for up to 1 year. CONCLUSIONS: * Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged >/= 75 years with OAB. * For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year. (c) 2010 THE AUTHORS. JOURNAL COMPILATION (c) 2010 BJU INTERNATIONAL.

Page last updated: 2011-12-09

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