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.
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.
Total Overactive Bladder Symptom Score was significantly decreased (6.21 ± 3.12 vs 4.38 ± 2.46; P<0.001). Although each score of several questionnaires, especially for storage symptoms, improved significantly, 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 Overactive Bladder Symptom Score, Core Lower Urinary Tract Symptom score, prostate volume and monotherapy with α-1 blocker were independent factors affecting the efficacy of vibegron.
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.
Urology. 2021 Jan 20 [Epub ahead of print]
Keisuke Ishikawa, Akira Tsujimura, Miho Miyoshi, Yuto Miyoshi, Taiki Ogasa, Ippei Hiramatsu, Yuka Uesaka, Taiji Nozaki, Masato Shirai, Isao Mitsuhashi, Sosuke Sugimura, Taiki Mizuno, Kensho Noto, Yasuhiro Shigeta, Shinichi Honda, Shinji Iwata, Shigeo Horie
Department of Urology, Juntendo University, Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan; Department of Urology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan., Department of Urology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan. Electronic address: ., Department of Urology, Juntendo University Urayasu Hospital, 2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan., Nishi-Funabashi Urology Clinic, 4-22-1 Nishihuna, Funabashi, Chiba 273-0031, Japan., Yatsu Hoken Hospital, 4-6-16 Yatsu, Narashino, Chiba 275-0026, Japan., Department of Urology, Juntendo University, Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.