An open-label, randomized, post-authorization study of mirabegron in Chinese participants with overactive bladder

Area of Science:

• Urology
• Pharmacology

Background:

• Overactive bladder (OAB) significantly impacts quality of life.
• Mirabegron is a beta-3 adrenergic agonist used for OAB treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of mirabegron at 25 mg/day and 50 mg/day doses in Chinese participants with overactive bladder.
• To determine the optimal dosage of mirabegron for OAB treatment in this population.

Main Methods:

• A 12-week, randomized, open-label study involving Chinese adults diagnosed with overactive bladder.
• Participants received either mirabegron 25 mg/day or 50 mg/day, with an option for dose escalation.
• Efficacy was assessed by changes in micturition frequency, urgency episodes, incontinence, and Overactive Bladder Symptom Score.

Main Results:

• The 50 mg/day mirabegron group showed a statistically significant reduction in mean daily micturitions from baseline to Week 12 (p<0.001).
• Both 25 mg/day and 50 mg/day doses demonstrated significant improvements in secondary efficacy endpoints at weeks 4, 8, and 12.
• The safety profile of mirabegron was consistent with previously established data.

Conclusions:

• Mirabegron, particularly at a 50 mg/day dosage, is an effective treatment for overactive bladder in the Chinese population.
• The study supports the use of mirabegron 50 mg/day for managing OAB symptoms in China.