Masaki Yoshida1, Masayuki Takeda2, Momokazu Gotoh3, Shinji Nagai4, Takafumi Kurose4. 1. Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Japan. Electronic address: akko-maki@umin.net. 2. Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Chuo, Japan. 3. Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan. 4. Kyorin Pharmaceutical Co. Ltd., Tokyo, Japan.
Abstract
BACKGROUND:Vibegron is a novel, potent, and selective β3-adrenoreceptor agonist for the treatment of patients with overactive bladder (OAB). OBJECTIVE: To evaluate the efficacy and safety of vibegron versus placebo in Japanese OAB patients. DESIGN, SETTING, AND PARTICIPANTS: Patients with OAB entered a 2-wkplacebo run-in phase. Once eligibility (≥8 micturition/d and either ≥1 urgency episodes/d or ≥1 urgency incontinence episodes/d) was confirmed, patients entered a 12-wk double-blind treatment phase. The anticholinergic imidafenacin was used as an active reference. INTERVENTION: A total of 1232 patients were randomly assigned to one of the four 12-wk treatment groups: vibegron (50mg or 100mg once daily), placebo, or imidafenacin (0.1mg twice daily). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was change in the mean number of micturitions/d at wk 12 from baseline. The secondary endpoints were changes from baselines in OAB symptom variables (daily episodes of urgency, urgency incontinence, incontinence, and nocturia, and voided volume/micturition). Quality of life (QoL) and safety were assessed. A constrained longitudinal data analysis model was used for analysis of efficacy. RESULTS AND LIMITATIONS: Patients taking vibegron 50mg and 100mg orally for 12 wk had significant improvements over the placebo in the primary and secondary endpoints. The proportions of patients with normalization of micturition, resolution of urgency, urgency incontinence, and incontinence were significantly greater than placebo. Vibegron significantly improved QoL, with high patient satisfaction. Incidences of drug-related adverse events with vibegron 50mg and 100mg were 7.6%, 5.4%, similar to placebo (5.1%), and less than imidafenacin (10.3%). Treatment was for just 12 wk and a long-term study is needed. CONCLUSIONS: The 12-wk treatment with vibegron is effective and well tolerated in patients with OAB. PATIENT SUMMARY: This randomized study demonstrated that vibegron is clinically useful for treatment of patients with OAB. Trial registration JapicCTI-152936. http://www.clinicaltrials.jp/user/cteDetail.jsp.
RCT Entities:
BACKGROUND:Vibegron is a novel, potent, and selective β3-adrenoreceptor agonist for the treatment of patients with overactive bladder (OAB). OBJECTIVE: To evaluate the efficacy and safety of vibegron versus placebo in Japanese OABpatients. DESIGN, SETTING, AND PARTICIPANTS: Patients with OAB entered a 2-wk placebo run-in phase. Once eligibility (≥8 micturition/d and either ≥1 urgency episodes/d or ≥1 urgency incontinence episodes/d) was confirmed, patients entered a 12-wk double-blind treatment phase. The anticholinergic imidafenacin was used as an active reference. INTERVENTION: A total of 1232 patients were randomly assigned to one of the four 12-wk treatment groups: vibegron (50mg or 100mg once daily), placebo, or imidafenacin (0.1mg twice daily). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was change in the mean number of micturitions/d at wk 12 from baseline. The secondary endpoints were changes from baselines in OAB symptom variables (daily episodes of urgency, urgency incontinence, incontinence, and nocturia, and voided volume/micturition). Quality of life (QoL) and safety were assessed. A constrained longitudinal data analysis model was used for analysis of efficacy. RESULTS AND LIMITATIONS: Patients taking vibegron 50mg and 100mg orally for 12 wk had significant improvements over the placebo in the primary and secondary endpoints. The proportions of patients with normalization of micturition, resolution of urgency, urgency incontinence, and incontinence were significantly greater than placebo. Vibegron significantly improved QoL, with high patient satisfaction. Incidences of drug-related adverse events with vibegron 50mg and 100mg were 7.6%, 5.4%, similar to placebo (5.1%), and less than imidafenacin (10.3%). Treatment was for just 12 wk and a long-term study is needed. CONCLUSIONS: The 12-wk treatment with vibegron is effective and well tolerated in patients with OAB. PATIENT SUMMARY: This randomized study demonstrated that vibegron is clinically useful for treatment of patients with OAB. Trial registration JapicCTI-152936. http://www.clinicaltrials.jp/user/cteDetail.jsp.