2008 Annual Meeting Abstracts

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Trospium Chloride Once-Daily Extended Release (XR) is Effective and Well Tolerated in Elderly Patients (aged ≥75 years) with Overactive Bladder (OAB)
Roger R Dmochowski¹, Peter K Sand², Eric S. Rovner³, Bobby W Sandage, Jr⁴, Mark D Harnett⁴, Pamela Ellsworth^5
1Vanderbilt University School of Medicine, Nashville, TN;²Northwestern University Feinberg School of Medicine, Nashville, TN;³Medical University of South Carolina, Charleston, SC;⁴Indevus Pharmaceuticals, Inc., Lexington, MA;⁵Brown University, Providence, RI

Introduction
Specific properties of trospium chloride once-daily 60mg XR, including low propensity to cross the blood-brain barrier, minimal cytochrome P450 metabolism, and low adverse event (AE) incidence, may be beneficial in elderly patients.
Materials & Methods
Pooled data were analyzed for patients >75 years from two randomized, double-blind studies of OAB patients receiving trospium XR 60mg or placebo once daily for 12 weeks.
Results
Of 1165 patients randomized, 143 were >75 years (85 trospium XR, 58 placebo; mean 79 years [maximum 90 years], ~75% female). At week 12, trospium XR produced greater improvements from baseline than placebo in voiding diary parameters (Table 1), OAB Patient Global Assessment, and QOL. Incidence of dry mouth (10.6% vs. 10.8%) and constipation (10.6% vs. 8.1%) was similar for patients >75 and <75 years, respectively. Among placebo treated patients >75 years, prevalence of dry mouth and constipation was 3.4% and 0%, respectively. CNS-related AEs were not observed with trospium XR. All other AE incidence rates were similar between patients >75 and <75 years. Efficacy and tolerability persisted among patients receiving open-label trospium XR out to 1 year.

Table 1. Changes in selected efficacy parameters from baseline to 12 weeks in patients treated with trospium XR or placebo
Parameter	Trospium XR	Placebo	p-value
Average daily toilet voids (mean)	-2.15	-0.37	<0.001
Average daily urge urinary incontinence (UUI) episodes (mean)	-1.77	-0.54	<0.01
Percent change in weekly UUI episodes (median)	-69.9	-25.0	<0.05
Average daily urge frequency (mean)	-2.53	-0.61	<0.01
Average urgency severity associated with toilet voids (mean)	-0.28	-0.20	0.3
Daily volume/toilet void (mL; mean)	+30.73	+3.10	<0.01

Conclusions
In the elderly, who experience OAB with high prevalence, trospium XR was effective and well tolerated. Trospium XR’s unique chemical and metabolic properties may contribute to improved tolerability when compared to other OAB medications (specifically considering the lack of CNS effects).

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