OBJECTIVE: To evaluate the efficacy and safety of the β3 -adrenoceptor agonist, mirabegron, in a Japanese population with overactive bladder (OAB).
PATIENTS AND METHODS: This randomized, double-blind, placebo-controlled Phase III study enrolled adult patients experiencing OAB symptoms for ≥24 weeks. Patients with ≥8 micturitions/24 h and ≥1 urgency episode/24 h or ≥1 urgency incontinence episode/24 h were randomized to once-daily placebo, mirabegron 50 mg, or tolterodine 4 mg (as an active comparator, without testing for non-inferiority of efficacy and safety) for 12 weeks. Primary endpoint was change from baseline to final assessment in mean number of micturitions/24 h. Secondary endpoints included micturition variables related to urgency and/or incontinence and quality of life (QOL) domain scores on the King's Health Questionnaire (KHQ). Safety assessments included adverse events (AEs), post-void residual volume, laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG). Registered at clinical trials.gov (NCT00966004).
RESULTS: A total of 1139 patients were randomized to receive placebo (n = 381), mirabegron 50 mg (n = 380), or tolterodine 4 mg (n = 378). Demographic and baseline characteristics were similar across groups. At final assessment, mirabegron showed significant improvements vs placebo in mean [SD] change from baseline in number of micturitions/24 h (-1.67 (2.212)vs -0.86 (2.354); P < 0.001) and in the secondary endpoints: number of urgency episodes/24 h (-1.85 (2.555) vs -1.37 (3.191); P = 0.025), incontinence episodes/24 h (-1.12 (1.475) vs -0.66 (1.861); P = 0.003), urgency incontinence episodes/24 h (-1.01 (1.338) vs -0.60 (1.745); P = 0.008), volume voided/micturition (24.300 (35.4767) mL vs 9.715 (29.0864) mL; P < 0.001). The incidence of AEs in the mirabegron group was similar to placebo; most AEs were mild and none were severe.
CONCLUSIONS: Mirabegron 50 mg once-daily is an effective treatment for OAB symptoms, with a low occurrence of side effects, in a Japanese population.
Written by:
Yamaguchi O, Marui E, Kakizaki H, Homma Y, Igawa Y, Takeda M, Nishizawa O, Gotoh M, Yoshida M, Yokoyama O, Seki N, Ikeda Y, Ohkawa S. Are you the author?
Division of Bioengineering and LUTD Research, Nihon University, School of Engineering, Koriyama, Japan.
Reference: BJU Int. 2014 Jan 28. Epub ahead of print.
doi: 10.1111/bju.12649
PubMed Abstract
PMID: 24471907
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