Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a [beta]3-adrenoceptor agonist, in patients with overactive bladder in Asia

• Published in: Neurourology and urodynamics 2015-09, Vol.34 (7), p.685
• Main Authors: Kuo, Hann-Chorng, Lee, Kyu-Sung, Na, Yanqun, Sood, Rajeev, Nakaji, Shigeru, Kubota, Yosuke, Kuroishi, Kentarou
• Format: Article
• Language: English
• ISSN: 0733-2467; 1520-6777
• DOI: 10.1002/nau.22645

Aims To assess the efficacy and safety of mirabegron 50mg once daily compared with placebo and the active control, tolterodine extended-release (ER) 4mg once daily, in patients with symptoms of overactive bladder (OAB) in Taiwan, Korea, China, and India. Methods A 12-week multinational, randomized, double-blind, parallel-group placebo- and active-controlled trial. The primary efficacy endpoint was change from baseline to final visit in mean number of micturitions/24hr. Secondary endpoints were: mean number of urgency episodes, incontinence episodes and urge incontinence episodes/24hr, mean number of nocturia episodes per night, mean volume voided per micturition, and quality-of-life (QoL) scores as assessed by the King's Health Questionnaire (KHQ). Results Of 1,126 patients who were randomized to receive double-blind study drug, 921 patients (300, 311, and 310 in the placebo, mirabegron 50mg, and tolterodine ER 4mg groups, respectively) completed the treatment period. Demographic characteristics were similar across treatment groups. A statistically significant improvement versus placebo in mean number of micturitions/24hr was seen with mirabegron 50mg at all timepoints (P