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Alan J. Wein, Philadelphia, PA, Paul Abrams, Bristol, UK, Rodney Appell, Cleveland, OH, Harold P. Drutz, Toronto, Canada (Presented by: Prof. A. Wein)

INTRODUCTION -- Overactive bladder is a chronic con-dition requiring long term therapy to maintain symptom relief. Antimuscarinic drugs such as oxybutynin have traditionally been the mainstay of therapy. How-ever, adverse events such as dry mouth cause poor long-term compliance. Tol-terodine (Detrol™ Tablets/Detrusitol® Tablets) is a new antimuscarinic agent specifically developed to treat the symptoms of frequency, urgency and urge in-continence caused by overactive bladder. Tolterodine's selectivity for the bladder over the salivary glands in vivo suggests a low propensity to cause adverse events and thus a possibility for patients to remain on therapy long-term. We pre-sent here the pooled results of open-label extension studies investigating the long-term efficacy and safety of tolterodine 2mg bd.

METHODS -- 815 patients who completed 8 double-blind, placebo-controlled, randomised studies of 2-4 weeks' duration were offered continued treatment for up to 12 months. Efficacy (change in micturitions/24h, urge incontinence epi-sodes/24h and volume voided/micturition) was determined after 6 and 12 months of treatment. Safety was assessed from spontaneously reported adverse events, measurement of vital signs and routine laboratory analysis.

RESULTS -- 512 of 815 (63%) patients completed 12 months of treatment. Efficacy results (% change) are presented below:
  Micturitions/24h Urge incontinence
Baseline 10.9 2.9 159
6 months 8.6 (-21.1) 1.4 (-51.7) 193 (+21.4)
12 months 8.6 (-21.1) 1.6 (-44.8) 190 (+19.5)

A total of 15% of patients withdrew because of adverse events, of which only 3% were as a result of dry mouth. There were no clinically relevant changes in vital signs or laboratory parameters.

CONCLUSIONS -- Tolterodine 2mg bd is well tolerated and its therapeutic effect is maintained long-term. Dry mouth was infrequent and was not a major cause of patient withdrawal. The high rate of compliance suggests that tolterodine is a real alternative for effective long-term treatment for overactive bladder.

Source: 1999 AUA Meeting


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