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 m

SUBMITTER: Hadi FA 

PROVIDER: S-EPMC12617816 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature