Mirabegron versus Placebo Add-on Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: a Safety Analysis from the Randomized, Phase 4 PLUS Study. Journal Article

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Authors: Herschorn, S; McVary, KT; Santos, JC; Foley, S; Kristy, RM; Choudhury, N; Hairston, J; Kaplan, SA
Article Title: Mirabegron versus Placebo Add-on Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: a Safety Analysis from the Randomized, Phase 4 PLUS Study.
Abstract: OBJECTIVES: To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: The Phase 4 PLUS study comprised 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). Doses were increased to mirabegron 50 mg or matched placebo after 4 weeks. Safety assessments: treatment-emergent adverse events (TEAEs), vital signs, 12-lead electrocardiograms (ECGs), and changes in post-void residual (PVR) volume and maximum urinary flow (Q). RESULTS: The safety analysis set included 352 tamsulosin plus mirabegron (TAM+MIRA) and 354 tamsulosin plus placebo (TAM+PL) patients. The frequency of overall TEAEs was higher with TAM+PL, although a higher incidence of drug-related TEAEs was observed with TAM+MIRA. Most TEAEs were mild or moderate in severity. Drug-related serious TEAEs were reported for three patients (two TAM+MIRA patients: acute myocardial infarction with cerebral infarction and angina pectoris, one TAM+PL patient: lacunar stroke). Hypertension, headache, and nasopharyngitis were the most common TEAEs. Special interest TEAEs were infrequently reported. The most common was urinary retention and two TAM+MIRA patients required catheterization (neither led to discontinuation). No major changes in blood pressure or pulse rate were noted and similar ECG parameters were observed for both groups. Changes in mean PVR volume and Q were not clinically meaningful. CONCLUSION: No unexpected safety concerns were noted in men receiving tamsulosin for LUTS associated with BPH who subsequently received mirabegron add-on therapy.
Journal Title: Urology
ISSN: 1527-9995; 0090-4295
Publisher: Elsevier Inc  
Date Published: 2020