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 immediate-release (IR) 2mg 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 4mg qd displayed a favourable safety, tolerability and efficacy profile during 12 months' treatment of patients with overactive bladder.
Kreder
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K
Department of Urology, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, 3120 RCP, Iowa City, IA 52242, USA. karl-kreder@uiowa.edu
Mayne
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Jonas
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D003408:Cresols / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D010665:Phenylpropanolamine; D013997:Time Factors; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate