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

OBJECTIVE To investigate the efficacy and safety of vibegron add-on therapy in men with persistent storage symptoms receiving alpha-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 alpha-1 blockers (22 patients) or PDE5 inhibitor (20 patients). The primary endpoint was change in the overactive Bladder (OAB) Symptom Score from baseline to end of treatment. The secondary endpoints were changes in each question of several question-naires, maximum flow rate and residual urine volume. Finally, independent factors affecting the efficacy of vibegron were investigated. RESULTS Total OAB Symptom Score was significantly decreased (6.21 +/- 3.12 vs 4.38 +/- 2.46; P < .001). Although each score of several questionnaires, especially for storage symptoms, improved signifi-cantly, no significant improvement was found in stress incontinence, straining, bladder pain and urethral pain in the Core Lower Urinary Tract Symptom score. Maximum flow rate and residual urine volume did not change, and no patient discontinued vibegron because of adverse events. Multiple regression analysis showed that OAB Symptom Score, Core Lower Urinary Tract Symp-tom score, prostate volume and monotherapy with alpha-1 blocker were independent factors affecting the efficacy of vibegron. CONCLUSION Add-on therapy of vibegron to monotherapy with alpha-1 blockers or PDE5 inhibitor for patients with benign prostatic hyperplasia and persistent storage symptoms was effective and safe. (C) 2021 Elsevier Inc.