Mirabegron/tamsulosin

Abstract

Various toxicities: 3 case reports In a study analysis of previously conducted PLUS study (a Phase 4, randomised, double-blind, multi-center trial) involving 706 men, who were receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BHP), three men [ages not stated] were described, who developed acute myocardial infarction and cerebral infarction (1 man), angina pectoris (1 man) and lacunar stroke (1 man) during treatment with tamsulosin and mirabegron for overactive bladder (OAB) symptoms [routes not stated]. The men, who had been receiving tamsulosin 0.4mg daily for LUTS associated with BHP were enrolled in the study. The study comprised a 4-week, open-label run-in period tamsulosin 0.4mg once daily, followed by a 12-week, double-blind treatment period with mirabegron 25mg or placebo. Two men received tamsulosin and mirabegron, and one man received tamsulosin and placebo. Subsequently, two patients, who received tamsulosin and mirabegron developed acute myocardial infarction and cerebral infarction (1 man) and angina pectoris (1 man). The remaining one patient, who received tamsulosin and placebo developed lacunar stroke [durations of treatment to reactions onsets and outcomes not stated].