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.
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Authors | Mineo Takei, Yukio Homma, JAPANESE TOLTERODINE STUDY GROUP |
Journal | International journal of urology : official journal of the Japanese Urological Association
(Int J Urol)
Vol. 12
Issue 5
Pg. 456-64
(May 2005)
ISSN: 0919-8172 [Print] Australia |
PMID | 15948744
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Cresols
- Delayed-Action Preparations
- Muscarinic Antagonists
- Phenylpropanolamine
- Tolterodine Tartrate
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Benzhydryl Compounds
(administration & dosage, therapeutic use)
- Cresols
(administration & dosage, therapeutic use)
- Delayed-Action Preparations
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Japan
- Male
- Middle Aged
- Muscarinic Antagonists
(administration & dosage, therapeutic use)
- Phenylpropanolamine
(administration & dosage, therapeutic use)
- Safety
- Time Factors
- Tolterodine Tartrate
- Treatment Outcome
- Urinary Incontinence
(drug therapy, physiopathology)
- Urodynamics
(drug effects, physiology)
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