Herschorn S, McVary KT, Santos JC, et al. - In this study, the safety of mirabegron add-on therapy was evaluated in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Researchers designed a Phase 4 PLUS study comprising a 4-week run-in period (tamsulosin [0.4 mg]) and a 12-week randomized treatment period (add-on treatment: mirabegron [25 mg] or placebo). This analysis enrolled 352 tamsulosin plus mirabegron (TAM+MIRA) and 354 tamsulosin plus placebo (TAM+PL) patients. The results of this study indicate that no unexpected safety concerns were reported in men receiving tamsulosin for LUTS correlated with BPH who subsequently received mirabegron add-on therapy.