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Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients.

AbstractAIM:
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.
AuthorsMineo Takei, Yukio Homma, JAPANESE TOLTERODINE STUDY GROUP
JournalInternational 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
PMID15948744 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Benzhydryl Compounds
  • Cresols
  • Delayed-Action Preparations
  • Muscarinic Antagonists
  • Phenylpropanolamine
  • Tolterodine Tartrate
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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