Karl-Erik Andersson led the peer-review process as the Associate Editor responsible for the paper.
Frontiers in Urology
Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability
Article first published online: 11 OCT 2013
© 2013 Wiley Periodicals, Inc.
Neurourology and Urodynamics
Volume 33, Issue 1, pages 17–30, January 2014
How to Cite
Chapple, C. R., Cardozo, L., Nitti, V. W., Siddiqui, E. and Michel, M. C. (2014), Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability. Neurourol. Urodyn., 33: 17–30. doi: 10.1002/nau.22505
Conflicts of interest: Christopher R. Chapple is a Consultant or Researcher for Allergan, Astellas, BioCSL, Lilly, Ono, Pfizer, and Ranbaxy. Linda Cardozo is a Consultant or Researcher for Astellas and Pfizer, and an Advisor for Allergan, Astellas, Ethicon, Merck, Pfizer, and Teva. Victor W. Nitti is a Consultant or Researcher for Allergan, American Medical Systems, Astellas, Coloplast, Medtronic, Ono, Pfizer, Ipsen, Serenity and Theracoat; a Speaker for Allergan and Astellas; and has Equity Interests in Serenity. Emad Siddiqui is an employee of Astellas Pharma Europe Ltd. Martin C. Michel is a Consultant or Researcher for Astellas, AltheRX, Boehringer Ingelheim, Pfizer, Bayer, and Apogepha; a Speaker for Astellas, Pfizer, and Allergan; a Director of Boehringer Ingelheim; and has Equity Interests in AltheRX.
- Issue published online: 11 DEC 2013
- Article first published online: 11 OCT 2013
- Manuscript Accepted: 13 SEP 2013
- Manuscript Received: 13 JUN 2013
- overactive bladder;
- β3-adrenoceptor agonist
Mirabegron, the first β3-adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date.
All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts.
In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency, urgency incontinence, and mean volume voided/micturition were seen as early as the first assessment (week 4) for mirabegron 50 and 100 mg, and were maintained throughout treatment. Responder analyses showed a significant improvement with mirabegron 50 and 100 mg in terms of dry rates, ≥50% reduction in mean number of incontinence episodes/24 hr, and the proportion of patients with ≤8 micturitions/24 hr at final visit. The benefit of mirabegron 50 and 100 mg was also evident in patients ≥65 years of age, and in both treatment-naïve patients and those who previously discontinued antimuscarinic therapy. These data therefore demonstrate a clinically meaningful benefit with mirabegron in the objective endpoints of OAB. Assessment of measures of health-related quality of life and treatment satisfaction showed that patients perceived treatment with mirabegron as meaningful. In OAB clinical trials of up to 12 months mirabegron appeared to be well tolerated. The most common adverse events (AEs) observed with mirabegron in clinical trials of up to 12 months were hypertension, nasopharyngitis, and urinary tract infection. The incidence of dry mouth was similar to placebo, and was between three and fivefold less than for tolterodine extended release 4 mg. Since dry mouth is the most bothersome AE associated with antimuscarinic drugs and often a reason for treatment discontinuation, mirabegron may be a valuable treatment option for these patients.
In Phase III clinical trials, mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating symptoms of OAB and, at doses of 50 and 100 mg, demonstrated significant improvements versus placebo on key secondary endpoints, as early as the first assessment (week 4), and these were maintained throughout treatment. In OAB clinical trials of up to 12 months, mirabegron appeared to be well tolerated. Neurourol. Urodynam. 33:17–30, 2014. © 2013 Wiley Periodicals, Inc.