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Trospium chloride once daily extended release 60 mg provides effective, long-term relief from symptoms of overactive bladder syndrome
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Trospium chloride once daily extended release 60 mg provides effective, long-term relief from symptoms of overactive bladder syndrome
Roger Dmochowski, MD1, David R. Staskin, MD2, Norman R. Zinner, MD3, Peter K. Sand, MD4.
1Vanderbilt University, Nashville, TN, USA, 2NewYork-Presbyterian/Weill Cornell, New York, NY, USA, 3Western Clinical Research, Inc., Torrance, CA, USA, 4Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Background: An extended-release (XR) formulation of the quaternary amine trospium chloride for once-daily administration has been shown to provide effective relief for the symptoms of overactive bladder syndrome (OAB) in two Phase III 12-week studies. Here, based on pooled data, we present an analysis of the primary endpoints of the 9-month, open-label treatment phase of two Phase III studies of trospium XR 60 mg in the treatment of OAB.
Methods: Adults with OAB of >/=6 months’ duration with urinary urgency, frequency, and an average of >/=1 urgency urinary incontinence (UUI) episode/day were eligible for inclusion in either of these multicenter, parallel-group, double-blind, placebo-controlled trials. Each study included a 12 week double-blind treatment period followed by a 9-month open-label period. Primary efficacy variables were change in the mean number of toilet voids/day and change in the mean number of UUI episodes/day.
Results: In total, 1027 patients completed the double-blind phase of the study; of these, 944 subjects continued into the open-label treatment period. Overall, 68.7% of the placebo-to-trospium subjects and 72.7% of the trospium-to-trospium subjects completed the 9-month open-label treatment period. There was a marked reduction in the number of daily toilet voids in subjects who switched to trospium XR while a continued improvement in the number of daily toilet voids was observed in subjects who remained on trospium XR throughout the double-blind and open-label study periods (Figure). The reduction in UUI episodes/day in the trospium-to-trospium subjects at Week 12 (-2.73 ± 0.15) was maintained at Week 48 (-2.79 ± 0.17) from a baseline of 4.02 ± 0.16 (data expressed as mean ± standard error). In the placebo-to-trospium subjects, the reduction in daily UUI episodes reached -2.64 ± 0.16 at Week 48 from a baseline of 4.08 ± 0.17.
Mean (± standard error) change in daily toilet voids in intent-to-treat patients
Conclusions: Patients treated with trospium XR experienced a reduction in daily toilet voids and UUI episodes that persisted for 9 months. Coupled with the high completion rate for patients enrolled in the open-label phase, these findings demonstrate that trospium XR is an effective and well tolerated long-term treatment for OAB.
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