Efficacy and Safety of Vibegron Add-on Therapy in Men with Persistent Storage Symptoms after Receiving Alpha 1-Blocker or Phosphodiesterase 5 Inhibitor: A Preliminary Study.

Abstract OBJECTIVES To investigate the efficacy and safety of vibegron add-on therapy in men with persistent storage symptoms receiving α-1 blockers or PDE5 inhibitor for benign prostatic hyperplasia and then determine the independent factors affecting the efficacy of vibegron. METHODS Vibegron 50 mg was administered for 12 weeks to 42 patients (72.0 ± 8.2 years) with persistent storage symptoms who had taken α-1 blockers (22 patients) or PDE5 inhibitor (20 patients). The primary endpoint was change in the Overactive Bladder Symptom Score from baseline to end of treatment. The secondary endpoints were changes in each question of several questionnaires, maximum flow rate and residual urine volume. Finally, independent factors affecting the efficacy of vibegron were investigated. RESULTS Total Overactive Bladder Symptom Score was significantly decreased (6.21 ± 3.12 vs 4.38 ± 2.46; P CONCLUSION Add-on therapy of vibegron to monotherapy with α-1 blockers or PDE5 inhibitor for patients with benign prostatic hyperplasia and persistent storage symptoms was effective and safe.