Largest ever overactive bladder study published in leading urology journal

March 14, 2001

New formulation of tolterodine demonstrates improved efficacy and tolerability over twice-daily formulation

MAASTRICHT, THE NETHERLANDS, [March 15, 2001] - The University Hospital of Maastricht today announced clinical trial results that demonstrate that patients taking a new, once-daily formulation of tolterodine, currently marketed in the U.S. as DETROL® LA (tolterodine tartrate tablets), reported a 71% reduction in incontinence episodes per week compared to 60% in patients treated with the twice-daily formulation of DETROL. The once-daily formulation was 18% more effective in reducing median incontinence episodes.

Published in this month's issue of Urology, the study is the largest placebo-controlled study conducted to date (n=1529 patients) for overactive bladder, a medical condition that affects millions of adults worldwide, including 17 million in the U.S. alone. Overactive bladder is marked by symptoms of frequent urination, and urgency with or without urge incontinence (wetting episodes).

"Overactive bladder is a disruptive but treatable condition that can be managed," said Philip Van Kerrebroeck, M.D., Ph.D., Chief, Department of Urology, University Hospital of Maastricht, The Netherlands, and principal investigator of the study. "The results of this study are the most promising to date in the research of therapeutic agents for overactive bladder. Once-daily tolterodine was shown to provide highly effective relief of overactive bladder symptoms with a very low occurrence of side effects, particularly dry mouth."

Study Overview and Results

The double blind study was conducted at 167 centers in Europe, North America and Australia. Patients were randomized to parallel groups to receive tolterodine 4 mg once-daily (n = 507), tolterodine 2 mg twice-daily (n = 512), or placebo (n = 508), for 12 weeks. In addition to evaluating the efficacy of once-daily tolterodine versus the twice-daily formulation, the study also compared the incidence of dry mouth, a common side effect of anti-muscarinic agents. Patients who received the once-daily formulation experienced a 23% improvement in episodes of dry mouth compared to patients in the twice-daily group. Overall, more patients on placebo withdrew from treatment due to adverse events than tolterodine-treated patients.

"The study demonstrates that the new formulation of tolterodine 4 mg once a day is the most advanced therapeutic agent for the treatment of overactive bladder, as it surpasses the efficacy and tolerability of the already-proven twice a day tolterodine preparation," said Dr. Van Kerrebroeck. "Furthermore, once-a-day dosing of tolterodine provides maximal patient convenience."
For More Information: Philip Van Kerrebroeck, M.D., Ph.D., University Hospital Maastricht, 011-31-43-387-7258
Ginger Hall, MCS Public Relations, 1-800-477-9626


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