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

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.