Session: LBA01: Late-Breaking Abstracts I - Benign
LBA01-18: Comparison of Mirabegron and Vibegron for Clinical Efficacy and Safety in Female Patients with Overactive Bladder: a Multicenter, Prospective Randomized Crossover Trial
Introduction: Mirabegron is approved as the first ß3-adrenoceptor agonist for overactive bladder (OAB). Vibegron is a secondly approved ß3-adrenoceptor agonist for OAB. The efficacy and safety of vibegron compared with mirabegron are unknown because of the lack of head-to-head comparative study. In this trial, we compared the efficacy and safety of mirabegron and vibegron in female OAB patients. Methods: We conducted a multicenter, prospective randomized crossover study. We enrolled female OAB patients aged =50 years, who had been treatment naive for OAB. The patients were assigned to Group MV or VM. Group MV patients were administered mirabegron (50 mg per day) for 8 weeks, followed by vibegron (50 mg per day) for 8 weeks. This order of drug administration was reversed in Group VM. There was no wash out period prior to crossover. At baseline, 8th week and 16th week, overactive bladder symptoms score (OABSS) consisting of daytime frequency, nighttime frequency, urgency and urgency incontinence, and frequency-volume charts (FVC) for 3 days were obtained in each patient. The primary end point is the change of OABSS from the baseline. After the completion of the trial, each patient was asked which drug was preferable. Results: A total of 80 patients enrolled in this trial (39 in Group MV and 41 in Group VM). At 8th and 16th week, 31 and 28 patients in Group MV and 33 and 29 in Group VM continued to receive the treatment. Three patients withdrew the treatment due to adverse events including dizziness in one during mirabegron, constipation and elevated postvoid residual (PVR) in one each during vibegron. The change of PVR was not significantly different during mirabegron (3.1±26.5 ml) and vibegron (7.9±9.8 ml) (p=0.43). Both mirabegron and vibegron significantly improved OABSS (-4.3±3.4 vs -5.3±3.4), daytime (-1.0±2.0 vs -1.6±2.0) and nighttime frequency (-0.3±1.0 vs -0.4±0.9) per day, mean (35±47 vs 42±47 ml) and maximum voided volume (55±96 vs 57±109 ml). There was no significant difference in the changes of these parameters between mirabegron and vibegron. After the completion of the trial, 15 and 33 of 57 patients preferred mirabegron (26%) and vibegron (58%), respectively. The other 9 patients (16%) had no preference. The change of urgency incontinence score of OABSS during vibegron was better in patients who preferred vibegron to mirabegron (-2.1±1.6 vs -1.1±1.4, p<0.05). Conclusions: The efficacy of mirabegron and vibegron for female OAB patients is similar. The patients’ preference for vibegron could be depending on the better efficacy for urgency incontinence. SOURCE OF Funding: none
