Adult urologyTolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder1☆,
Section snippets
Material and methods
This multinational, randomized, double-blind, placebo-controlled study was conducted in 167 centers in Australasia (n = 4), Europe (n = 89), and North America (n = 74). The study was conducted in accordance with the Good Clinical Practice Guidelines and the Declaration of Helsinki. The ethics committees approved the study protocol, and all patients gave written informed consent before the start of the study.
Results
A total of 1529 patients with overactive bladder were randomized into the study. The study population was representative of an expected population of patients with overactive bladder. Thus, most patients (81%) were women and approximately 50% of patients in each treatment group had received previous treatment for overactive bladder, 41% of whom had experienced poor results. The treatment groups were also well matched with regard to demographic and baseline disease characteristics (Table I).
All
Comment
Overactive bladder is a chronic condition that requires long-term treatment to maintain symptom relief. Numerous large, multinational, multicenter studies have confirmed the efficacy of tolterodine IR in treating the symptoms of overactive bladder.8, 9, 10, 11, 12 However, a once-daily administration may be viewed as potentially more convenient by patients, and this could lead to increased compliance.13 This study was the first large, multinational, multicenter, placebo-controlled investigation
Conclusions
At a dosage of 4 mg once daily, the ER formulation of tolterodine produces significant improvements in the symptoms of overactive bladder compared with placebo. The ER formulation was more effective in reducing the incontinence episodes and was better tolerated than the IR formulation, with a lower frequency of dry mouth at all severity levels. The advent of this new, once-daily formulation of tolterodine, combining highly effective relief of symptoms with minimal side effects and maximal
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This study was sponsored by Pharmacia Corporation.