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A proof-of-concept study: mirabegron, a new therapy for overactive bladder
Christopher R Chapple1, Gerard Amarenco, Miguel A López Aramburu
1Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK.
Neurourology and Urodynamics
|February 21, 2013
Summary
Mirabegron effectively reduced overactive bladder (OAB) symptoms, significantly improving micturition frequency compared to placebo. This study establishes mirabegron as a well-tolerated, novel oral therapy for OAB.
Area of Science:
- Pharmacology
- Urology
- Clinical Trials
Background:
- Overactive bladder (OAB) significantly impacts quality of life.
- Existing OAB treatments have limitations.
- Novel therapeutic targets for OAB are needed.
Purpose of the Study:
- To assess the efficacy and safety of mirabegron, a selective β3-adrenoceptor agonist, for OAB symptom treatment.
- To establish mirabegron as a potential new oral pharmacological therapy for OAB.
Main Methods:
- A Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
- 314 patients with OAB received mirabegron (100 or 150 mg twice-daily), placebo, or tolterodine ER (4 mg once-daily) for 4 weeks.
- Primary endpoint: change in micturition frequency; secondary endpoints: incontinence, urgency, quality of life.
Main Results:
- Mirabegron (100 and 150 mg BID) significantly reduced micturition frequency compared to placebo (P ≤ 0.01).
- Statistically significant improvements were observed for most secondary endpoints, including quality of life.
- Mirabegron demonstrated good safety and tolerability, with a minor increase in pulse rate.
Conclusions:
- Mirabegron is an efficacious and well-tolerated treatment for overactive bladder symptoms.
- Mirabegron represents a new class of oral pharmacological therapy for OAB, the first in over 30 years.
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