Objective: To present a systematic review assessing the efficacy and safety of mirabegron for overactive bladder (OAB). Materials and Methods: A literature search was performed using the Cochrane Library, MEDLINE, EMBASE and Science Citation Index Expanded. The literature reviewed included meta-analyses, randomized and nonrandomized prospective studies. We utilized mean difference (MD) to measure the mean number of incontinence episodes and the mean number of micturitions, and OAB questionnaire (OAB-q) and odds ratio (OR) to measure adverse events rates. We used the Cochrane Collaboration's Review Manager 5.1 software for statistical analysis. Results: We identified six publications that strictly met our eligibility criteria. Meta-analysis of extractable data showed that mirabegron was more effective than placebo in treating OAB despite different drug dosages in the efficacy end points: mean number of incontinence episodes per 24 h (MD -0.54; 95% CI -0.63, -0.45; p = 0.001), mean number of micturitions per 24 h (MD -0.55; 95% CI -0.63, -0.47; p = 0.001), OAB-q (MD -4.49; 95% CI -6.27, -2.71; p = 0.001) and adverse events (OR 0.99; 95% CI 0.83, 1.19; p = 0.92). When compared to tolterodine, mirabegron was more effective in terms of mean number of incontinence episodes per 24 h (MD -0.25; 95% CI -0.43, -0.06; p = 0.009). However, there were no differences between mirabegron and tolterodine in mean number of micturitions per 24 h (MD -0.17; 95% CI -0.35, 0.01; p = 0.07) and OAB-q (MD -1.09; 95% CI -2.51, 0.33; p = 0.13). Mirabegron also had a lower adverse reaction rate (OR 0.9; 95% CI 0.8, 1.0; p = 0.04). Conclusions: In this diverse population, mirabegron was an effective and safe pharmacologic therapy for OAB.

1.
Abrams P, Cardozo L, Fall M, et al: The standardisation of terminology of lower urinary tract function: report from the Standardisation Subcommittee of the International Continence Society. Neurourol Urodyn 2002;21:167-178.
2.
Abrams P, Chapple C, Khoury S, Roehrborn C, De la Rosette J: Evaluation and treatment of lower urinary tract symptoms in older men. J Urol 2013;189:S93-S101.
3.
Milsom I, Abrams P, Cardozo L, Roberts R, Thüroff J, Wein A: How widespread are the symptoms of an overactive bladder and how are they managed? A populationbased prevalence study. BJU Int 2001;87:760-766.
4.
Stewart WF, Van Rooyen JB, Cundiff GW, et al: Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327-336.
5.
Irwin DE, Milsom I, Hunskaar S, et al: Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006;50:1306-1314; discussion 1314-1315.
6.
Symonds T: A review of condition-specific instruments to assess the impact of urinary incontinence on health-related quality of life. Eur Urol 2003;43:219-225.
7.
Tyagi P, Tyagi V: Mirabegron, a beta(3)-adrenoceptor agonist for the potential treatment of urinary frequency, urinary incontinence or urgency associated with overactive bladder. IDrugs 2010;13:713-722.
8.
Tyagi P, Tyagi V, Chancellor M: Mirabegron: a safety review. Expert Opin Drug Saf 2011;10:287-294.
9.
Sanford M: Mirabegron: a review of its use in patients with overactive bladder syndrome. Drugs 2013;73:1213-1225.
10.
Andersson KE: Prospective pharmacologic therapies for the overactive bladder. Ther Adv Urol 2009;1:71-83.
11.
Takasu T, Ukai M, Sato S, et al: Effect of (R)-2-(2-aminothiazol-4-yl)-4′-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther 2007;321:642-647.
12.
Chapple CR, Dvorak V, Radziszewski P, et al: A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int Urogynecol J 2013;24:1447-1458.
13.
Chapple CR, Amarenco G, Lopez Aramburu MA, et al: A proof-of-concept study: mirabegron, a new therapy for overactive bladder. Neurourol Urodyn 2013;32:1116-1122.
14.
Herschorn S, Barkin J, Castro-Diaz D, et al: A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology 2013;82:313-320.
15.
Khullar V, Amarenco G, Angulo JC, et al: Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol 2013;63:283-295.
16.
Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S: Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol 2013;189:1388-1395.
17.
Chapple CR, Kaplan SA, Mitcheson D, et al: Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol 2013;63:296-305.
18.
Higgins JP, Green S (eds): Cochrane Handbook for Systematic Reviews of Interventions. Wiley Online Library 2008.
19.
Michel MC, Ochodnicky P, Homma Y, Igawa Y: Beta-adrenoceptor agonist effects in experimental models of bladder dysfunction. Pharmacol Ther 2011;131:40-49.
20.
Novack GD, Lewis RA, Vogel R, et al: Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther 2013;29:674-680.
21.
Caremel R, Loutochin O, Corcos J: What do we know and not know about mirabegron, a novel β3 agonist, in the treatment of overactive bladder? Int Urogynecol J 2014;25:165-170.
22.
Cui Y, Zong H, Yang C, Yan H, Zhang Y: The efficacy and safety of mirabegron in treating OAB: a systematic review and meta-analysis of phase III trials. Int Urol Nephrol 2014;46:275-284.
23.
Wagg A, Majumdar A, Toozs-Hobson P, Patel AK, Chapple CR, Hill S: Current and future trends in the management of overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:81-94.
24.
Chapple CR, Khullar V, Gabriel Z, Muston D, Bitoun CE, Weinstein D: The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 2008;54:543-562.
25.
Paquette A, Gou P, Tannenbaum C: Systematic review and metaanalysis: do clinical trials testing antimuscarinic agents for overactive bladder adequately measure central nervous system adverse events? J Am Geriatr Soc 2011;59:1332-1339.
26.
Buser N, Ivic S, Kessler TM, Kessels AG, Bachmann LM: Efficacy and adverse events of antimuscarinics for treating overactive bladder: network meta-analyses. Eur Urol 2012;62:1040-1060.
27.
Marinkovic SP, Rovner ES, Moldwin RM, Stanton SL, Gillen LM, Marinkovic CM: The management of overactive bladder syndrome. BMJ 2012;344:e2365.
28.
Nitti VW, Khullar V, van Kerrebroeck P, et al: Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. Int J Clin Pract 2013;67:619-632.
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