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

Abstract

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.

• Authors: Peter K Sand, Theodore M Johnson Ii, Eric S Rovner, Pamela I Ellsworth, Michael G Oefelein, David R Staskin
• Journal: BJU international (BJU Int) Vol. 107 Issue 4 Pg. 612-20 (Feb 2011) ISSN: 1464-410X [Electronic] England
• PMID: 20707790 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.

Chemical References

• Benzilates
• Delayed-Action Preparations
• Muscarinic Antagonists
• Nortropanes
• trospium chloride

Topics

• Aged
• Aged, 80 and over
• Benzilates
• Delayed-Action Preparations
• Epidemiologic Methods
• Female
• Humans
• Male
• Muscarinic Antagonists (adverse effects, therapeutic use)
• Nortropanes (adverse effects, therapeutic use)
• Patient Satisfaction
• Quality of Life
• Treatment Outcome
• Urinary Bladder, Overactive (drug therapy)