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Long‐term safety, tolerability and efficacy of extended‐release tolterodine in the treatment of overactive bladder in Japanese patients
Author(s) -
TAKEI MINEO,
HOMMA YUKIO
Publication year - 2005
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/j.1442-2042.2005.01066.x
Subject(s) - tolterodine , tolerability , medicine , overactive bladder , adverse effect , urination , placebo , urology , urinary incontinence , randomized controlled trial , anesthesia , urinary system , alternative medicine , pathology
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.