Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients
Version of Record online: 10 JUN 2005
International Journal of Urology
Volume 12, Issue 5, pages 456–464, May 2005
How to Cite
TAKEI, M., HOMMA, Y. and THE JAPANESE TOLTERODINE STUDY GROUP (2005), Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients. International Journal of Urology, 12: 456–464. doi: 10.1111/j.1442-2042.2005.01066.x
- Issue online: 10 JUN 2005
- Version of Record online: 10 JUN 2005
- Received 25 February 2004; accepted 20 October 2004.
- overactive bladder;
Abstract Aim: To evaluate the long-term safety, tolerability and efficacy of extended-release (ER) tolterodine in Japanese patients completing 12-week treatment in a randomized, double-blind trial comparing tolterodine ER 4 mg once daily, oxybutynin 3 mg three times daily or placebo in patients with overactive bladder.
Methods: Of 293 Japanese patients completing the 12-week study, 188 continued in the open-label trial and received tolterodine ER 4 mg once daily for 12 months, irrespective of previous treatment. The primary objective was to assess the safety of tolterodine ER for up to 52 weeks of treatment and at post-treatment follow-up. Secondary endpoints included changes in micturition diary variables, patient perception of bladder condition and urgency and treatment benefit.
Results: Overall, 77% of patients completed 12 months of open-label treatment. Tolterodine ER was well tolerated and the most common adverse event was dry mouth (33.5%). In general, there was no increase in adverse event frequency with long-term treatment compared with short-term treatment. The efficacy of tolterodine ER was maintained over the 12-month period. The complete analysis showed a median reduction in incontinence episodes/week (−92.9%; mean reduction, −77.2%), a mean reduction in micturitions/24 h (−21.3%) and a mean increase in volume voided per micturition (19.6%). Of patients completing the 12-month study, 78.6% reported improvement in patient perception of bladder condition, 52.4% reported improvement in perception of urgency and 89.7% reported treatment benefit.
Conclusions: Favorable safety, tolerability and efficacy of once-daily tolterodine ER was maintained over 12 months in a Japanese overactive bladder patient population.