Long-Term Safety, Tolerability and Efficacy of Extended-Release Tolterodine in the Treatment of Overactive Bladder
Background: The objective of the present study was to examine the long-term safety, tolerability and efficacy of tolterodine extended-release (ER) in patients who had completed 12 weeks’ treatment in a randomised, double-blind study comparing tolterodine ER 4 mg once daily (qd), tolterodine immediat...
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Published in | European urology Vol. 41; no. 6; pp. 588 - 595 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
Published |
Oxford
Elsevier B.V
01.06.2002
Elsevier |
Subjects | |
Online Access | Get full text |
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Summary: | Background:
The objective of the present study was to examine the long-term safety, tolerability and efficacy of tolterodine extended-release (ER) in patients who had completed 12 weeks’ treatment in a randomised, double-blind study comparing tolterodine ER 4
mg once daily (qd), tolterodine immediate-release (IR) 2
mg twice daily and placebo.
Methods:
Of the 1377 patients completing the 12-week study, a total of 1077 (78%) chose to continue with 12 months’ open-label treatment with tolterodine ER 4
mg once daily, irrespective of their previous treatment. Safety was assessed after 3, 6, 9 and 12 months’ treatment in the study. Efficacy was evaluated from micturition diary variables and patients’ perception of bladder condition and urgency following 3 and 12 months’ treatment.
Results:
71% of patients completed the 12-month study. Tolterodine ER was safe and well tolerated. Adverse events of the general (14.5%), autonomic (13.2%), gastrointestinal (11.4%), respiratory (9.8%) and urinary (9.1%) systems were the most frequently reported. Dry mouth was the most common event, occurring in 12.9% of patients, and was generally mild in severity. Other adverse events occurred in less than 5% of patients. There was no increase in the frequency of adverse events with long-term relative to short-term treatment. The efficacy of tolterodine was maintained over the 12-month treatment period; relative to baseline there were reductions in the number of incontinence episodes per week (median change −83%) and micturitions per 24 hours (median change −21%) and an increase in volume voided (median change +25%) after 12 months’ treatment. An improvement in patient perception of their bladder condition was found in 75% of patients completing the study, and 51% had an improvement in patient perception of urgency.
Conclusions:
Tolterodine ER 4
mg qd displayed a favourable safety, tolerability and efficacy profile during 12 months’ treatment of patients with overactive bladder. |
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Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23 |
ISSN: | 0302-2838 1873-7560 |
DOI: | 10.1016/S0302-2838(02)00177-X |