Mirabegron for the treatment of overactive bladder: a review of efficacy, safety and tolerability with a focus on male, elderly and antimuscarinic poor-responder populations, and patients with OAB in Asia

ABSTRACT

Introduction: Mirabegron is established as an alternative monotherapy to antimuscarinics for the treatment of overactive bladder (OAB) symptoms. Initial studies focused on Western populations, but over the past few years other populations and subpopulations have been evaluated.

Areas covered: The authors’ knowledge of the literature was used to develop the manuscript alongside a PubMed search (‘mirabegron and clinical trial’ and ‘overactive bladder’) to select independent studies of mirabegron. Up-to-date information is provided about the most recent mirabegron clinical trial and real-world efficacy, safety and tolerability data in a variety of patient populations with OAB, including those from different geographic areas, men, the elderly, and those with poor tolerability to antimuscarinics.

Expert commentary: Improvements in efficacy parameters in patients with OAB at mirabegron doses approved for clinical use (25 and 50 mg/day) are also associated with clinically meaningful benefits according to patient-reported outcomes. Mirabegron has a favorable safety and tolerability profile, particularly compared with antimuscarinics, for dry mouth, constipation, and many CNS effects, which is maintained over 1 year. A growing body of evidence suggests that mirabegron represents a new treatment option for a broad range of patients with OAB.

KEYWORDS:

• Antimuscarinic
• β₃-adrenoceptor agonist
• LUTS
• mirabegron
• overactive bladder
• urinary incontinence
• urinary urgency

Declaration of interest

C Chapple is a consultant, research and speaker for Allergan, Astellas, Medtronic and Recordati. C Chapple is a consultant and speaker for Lilly, and a researcher and speaker for ONO and Pfizer and a speaker for Ranbaxy. E Siddiqui is an employee of Astellas. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial assistance was utilized in the preparation of this manuscript, it was funded by Astellas Pharma Global Development and carried out by Jackie van Bueren of Envision Scientific Solutions.

Additional information

Funding

Medical writing assistance was provided by Envision Pharma, funded by Astellas Pharma Global Development.