Efficacy of vibegron in patients with overactive bladder: Multicenter prospective study of real-world clinical practice in Japan, SCCOP study 19-01

Objective To evaluate the efficacy and safety of vibegron in patients with overactive bladder (OAB) in real-world clinical practice in Japan. Methods This multicenter, prospective, non-controlled study consecutively enrolled patients with OAB determined by an OAB symptom score (OABSS) of three points or more and a question 3 (urgency) score of two points or more. A total of 212 patients from 43 institutions were recruited from January 2019 through March 2020. Vibegron, 50 mg, was administrated daily for 8 weeks as first-line monotherapy (first-line group, FL), monotherapy switching from antimuscarinics (post-antimuscarinic group, PA) or mirabegron (post-mirabegron group, PM) and combination therapy with antimuscarinics (add-on group). The OABSS was collected at baseline and every 2 weeks. Adverse events were recorded at every visit. Results Of the 212 patients registered, 188 (male 76, female 112) were eligible for analysis (124 in the FL group, 27 in PA, 29 in PM, and eight in the add-on group). The add-on group was excluded from further analysis due to its small number. The OABSS (mean +/- SD) showed significant improvement in all groups (FL; 8.8 +/- 2.5, 3.8 +/- 2.8, PM; 9.4 +/- 2.2, 4.5 +/- 4.0, PM; 8.9 +/- 2.5, 4.7 +/- 3.3 at 0 and 8 weeks, respectively). The overall incidence of adverse events was 25%. No grade 3 or higher adverse events were observed. Conclusions In the real-world clinical setting, vibegron is effective and well-tolerated by OAB patients, including those switching therapy from antimuscarinics and mirabegron.