Safety and Effectiveness of Vibegron in Japanese Patients With Overactive Bladder: A Japanese Postmarketing Survey

• Published in: Lower urinary tract symptoms 2024-11, Vol.16 (6), p.e12535-n/a
• Main Authors: Yoshimura, Shoko, Yagi, Hiromitsu, Abe, Kazunori, Yamasaki, Masakazu
• Format: Article
• Language: English
• Subjects: Adrenergic beta-3 Receptor Agonists - adverse effects; Adrenergic beta-3 Receptor Agonists - therapeutic use; Adult; Aged; Aged, 80 and over; Bladder; East Asian People; Female; Humans; Japan; Male; Middle Aged; Original; overactive bladder; postmarketing survey; Product Surveillance, Postmarketing; Prospective Studies; Pyrimidinones - adverse effects; Pyrimidinones - therapeutic use; Pyrrolidines - adverse effects; Pyrrolidines - therapeutic use; Quality of Life; Treatment Outcome; Urinary Bladder, Overactive - drug therapy; Urinary retention; vibegron; β3‐adrenoceptor agonist
• ISSN: 1757-5664; 1757-5672; 1757-5672
• DOI: 10.1111/luts.12535

ABSTRACT Objectives To evaluate the safety and effectiveness of vibegron, a highly selective β3‐adrenoceptor agonist, in Japanese patients with overactive bladder (OAB) in a real‐world clinical setting. Methods This prospective survey was conducted from August 2019 to July 2023 using a central registration method. Patients newly treated with vibegron for OAB were followed for 12 weeks, and those who continued treatment were observed for up to 52 weeks. Adverse drug reactions (ADRs) and the overall improvement level were assessed, and overactive bladder symptom score (OABSS) and International Prostate Symptom Score‐Quality of Life (IPSS QOL) score were collected. Results Of the 1848 patients in the safety analysis set, 154 ADRs were reported in 141 patients (7.63%). Common ADRs were increased residual urine volume (1.30%), constipation (1.14%), dysuria and urinary retention (0.97% each), cystitis (0.65%), and dry mouth (0.32%). The incidence of urinary retention‐related adverse events (AEs) was higher in male patients, patients ≥ 65 years old, and patients with benign prostatic hyperplasia. The effectiveness rate was 88.8% among the 1561 patients in the effectiveness analysis set. Significant improvement in both OABSS and IPSS QOL scores was observed at all observation periods. The rate of achieving the minimal clinically important change in OABSS total score at the final evaluation was 75.35%. OABSS scores were also significantly reduced in all subgroup analyses. Conclusions This survey found no major concerns regarding the safety and effectiveness of vibegron in Japanese OAB patients, except for urinary retention‐related AEs. Vibegron is considered to represent a useful drug for treating OAB symptoms in a real‐world clinical setting.