The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy

Abstract

Background: We conducted a meta-analysis to assess the efficacy and safety of mirabegron on overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving tamsulosin therapy. Methods: We performed the analysis by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The databases including MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were retrieved to get information regarding randomized controlled trials of mirabegron on OAB induced by BPH in men receiving tamsulosin therapy. We also searched the references of included literatures. Results: Three randomized controlled trials containing a total of 1317 BPH patients were included in the analysis. Co-primary efficacy end points: the mean number of micturitions per day [the mean difference (MD) = –0.27, 95% confidence interval (CI): –0.46 to –0.09, P = .004], the urgency episodes per day (the MD = –0.50, 95% CI: –0.77 to –0.22, P = .0004), the total OAB symptom score (the MD = –0.69, 95% CI: –1.00 to –0.38, P < .0001), and mean volume voided (the MD = 10.76, 95% CI: 4.87–16.64, P = .0003) indicated that mirabegron was effective in treating OAB induced by BPH in men receiving tamsulosin therapy. Safety assessments that included treatment-emergent adverse events (odds ratio = 0.88, 95% CI: 0.68–1.13, P = .31) indicated that mirabegron was well tolerated with the exception of post-void residual urine volume (MD = 12.02, 95% CI: 6.01–18.04, P < .0001). Conclusions: This analysis demonstrates that mirabegron is an effective and safe treatment for OAB symptoms induced by BPH in men receiving tamsulosin therapy with a low occurrence of side effects. Besides, we should be aware that the administration of mirabegron might have the risk of increasing post-void residual urine volume.

Comparative Efficacy of Different Drugs for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia: A Bayesian Network Meta-Analysis

“… Kaplan et al (2020) also found that the increase in PVR upon combination therapy is not statistically significant. However, the analyses by Su et al (2020) and Ichihara et al (2015) identified that the combined use will cause the average volume change of PVR to be significantly higher than that of tamsulosin (AB) alone. Pairwise meta-analysis in this study suggested a similar conclusion.…”

Effects of β3-adrenoceptor agonist on acute urinary retention in a rat model

“…§: between mirabegron-treated and saline-treated rats (P = 0.066). Data are represented as mean ± SD, a Student's t test risk of increasing urinary retention [20]. In a randomized trial [21], add-on mirabegron while receiving tamsulosin with BPH, associated with increasing the PVR (mean change 14.7 mL, 95% CI 8.5, 21.0 mL).…”

Optimizing Nonsurgical Treatments of Overactive Bladder in the United States

“…Men with benign prostatic hyperplasia may have OAB in the form of concomitant lower urinary tract bladder storage symptoms, such as frequent micturition and nocturia. 55,56 Results from studies of antimuscarinics (eg, tolterodine ER) 57 and a b3-adrenergic agonist (ie, mirabegron) 58 alone or in combination with standard therapy for benign prostatic hyperplasia have shown improvement in these symptoms.…”