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

Abstract

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.

Mirabegron versus vibegron in previously untreated female patients with overactive bladder: A randomized, single‐clinic, open‐label trial

“…25 A recent prospective study using 50 mg vibegron showed that the mean change in OABSS from baseline to EOT was À4.98 for men and women (mean age 73 years). 26 The present study showed that treatment with both mirabegron and vibegron greatly exceeded the MCIC. The higher efficacy observed in this study may have been because the target population was female patients with no prior history of OAB.…”

“…Another RCT reported that the change in OABSS was −4.51 ± 3.05 (mean age 73.5 years) 25 . A recent prospective study using 50 mg vibegron showed that the mean change in OABSS from baseline to EOT was −4.98 for men and women (mean age 73 years) 26 . The present study showed that treatment with both mirabegron and vibegron greatly exceeded the MCIC.…”

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder

“…The efficacy of 50 or 100 mg of vibegron on urgency incontinence and nocturia was also proved in a post hoc analysis. After the formal launch of vibegron (50 mg) in Japan, an uncontrolled multicenter study investigated its efficacy and safety in real-world settings [14]. Patients with various OAB medication histories were prescribed daily vibegron for 8 weeks.…”