The Role of Mirabegron in Overactive Bladder: A Systematic Review and Meta-Analysis

Abstract

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.

Comparative assessment of the efficacy of onabotulinumtoxinA and oral therapies (anticholinergics and mirabegron) for overactive bladder: a systematic review and network meta‐analysis

“…Consistent with our present findings, three systematic reviews found mirabegron had similar efficacy to most antimuscarinics [34][35][36] and, where studied, all were more efficacious than placebo in reducing the frequency of UI and micturitions [35,36]. In contrast, another meta-analysis showed mirabegron to be more effective than tolterodine in the number of UIE/day, but not for micturition frequency [37]. A systematic review of non-antimuscarinic treatments for OAB, including lifestyle changes, found only one study each of onabotulinumtoxinA and mirabegron compared with active treatment [38].…”

Systematic review and meta‐analysis on the efficacy and tolerability of mirabegron for the treatment of storage lower urinary tract symptoms/overactive bladder: Comparison with placebo and tolterodine

“…As dry mouth is the most bothersome TEAE related to antimuscarinic therapies, Mir might represent a valid option for the treatment of these patients. The present results confirm a previous meta‐analysis on six RCTs in which Mir showed a similar incidence of AEs when compared with a placebo, and a lower adverse reaction rate than Tol (OR 0.9; P = 0.04) . Furthermore, antimuscarinics can also contribute to a patient's anticholinergic cognitive burden, so the Beers Criteria recommends cautious use of antimuscarinics in elderly patients who take multiple anticholinergic medications or have cognitive impairment.…”

“…Another systematic review and meta‐analysis of six RCTs (BLOSSOM, DRAGON, SCORPIO, ARIES, CAPRICORN and TAURUS) showed that Mir was more effective in terms of the mean number of incontinence episodes per 24 h, although there were no differences between Mir and Tol in the mean number of micturitions per 24 h …”

“…13 In the same year, Wu et al added to the four RCTs phase III trials another two phase II RCTs, evaluating the efficacy and safety of Mir versus Tol too. 16 However, they did not analyze all the efficacy compounds of Mir, such as the reduction of nocturia episodes. Furthermore, two large RCTs on Mir versus placebo and Tol were published in 2014.…”

Adverse events and treatment discontinuations of antimuscarinics for the treatment of overactive bladder in older adults: A systematic review and meta-analysis

“…Several systematic reviews and meta-analyses have evaluated the use of medications in the treatment of OAB (Chapple et al, 2015; Chapple et al, 2008; Cui et al, 2014; Herbison et al, 2003; Huang et al, 2015; Kessler et al, 2011; Luo et al, 2012; Madhuvrata et al, 2012; Novara et al, 2008; Paquette et al, 2011; Reynolds et al, 2015; Roxburgh et al, 2007; Wu et al, 2014; Wyndaele et al, 2014). These reviews compared OAB medications to placebo and/or to other OAB medications, either directly or indirectly, using prospective randomized, non-randomized, and retrospective observational trials.…”