Long-Term Safety, Tolerability and Efficacy of Extended-Release Tolterodine in the Treatment of Overactive Bladder

• Published in: European urology Vol. 41; no. 6; pp. 588 - 595
• Main Authors: Kreder, K, Mayne, C, Jonas, U
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.06.2002; Elsevier
• Subjects: Adult; Aged; Aged, 80 and over; Benzhydryl Compounds - administration & dosage; Biological and medical sciences; Cresols - administration & dosage; Delayed-Action Preparations; Double-Blind Method; Efficacy; Female; Humans; Male; Medical sciences; Middle Aged; Muscarinic Antagonists - administration & dosage; Overactive bladder; Pharmacology. Drug treatments; Phenylpropanolamine; Safety; Time Factors; Tolerability; Tolterodine; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Neurogenic - drug therapy; Urinary system; Tolterodine; Overactive bladder; Efficacy; Tolerability; Safety; Human; Voiding dysfunction; Chemotherapy; Urinary system disease; Treatment; Adult; Exploration; Female; Bladder disease; Urinary tract disease; Urinary stress incontinence
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/S0302-2838(02)00177-X

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.