Efficacy and Safety of Mirabegron in Males with Overactive Bladder and Lower Urinary Tract Symptoms: Analysis from an Integrated Database
Abstract
Background and objective: Several phase 2-4 studies have investigated mirabegron for treating patients with overactive bladder (OAB). The objective of this study was to evaluate the efficacy and safety of mirabegron in adult male OAB patients with or without benign prostate enlargement (BPE) receiving medications for lower urinary tract symptoms (LUTS) management.
Methods: A post hoc analysis of 13 phase 2-4 studies using mirabegron (2- or 4-wk single-blind placebo run-in followed by 12-wk double-blind treatment period) was conducted. The studies had four treatment arms-(1) mirabegron beginning with 25 mg and then escalated to 50 mg (25/50 mg), (2) mirabegron 50 mg, (3) mirabegron 25/50 mg + tamsulosin hydrochloride (HCl) 0.4 mg, and (4) mirabegron 50 mg + tamsulosin HCl 0.2 mg, and three cohorts-cohort 1, OAB males overall; cohort 2, OAB males with concomitant BPE taking alpha blockers; and cohort 3, OAB males with concomitant BPE taking other LUTS medications (not alpha blockers). The primary efficacy endpoints were change from baseline to 12 wk in the mean daily number of micturitions and mean daily number of incontinence episodes. The secondary endpoints included safety, tolerability, and measures of OAB derived from the daily micturition diary, and patient-reported outcomes of voiding and storage.
Key findings and limitations: These results showed improvement in the primary and most secondary endpoints. Participants taking alpha blockers and mirabegron had increased…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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