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-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 (50 mg or 100 mg once daily), placebo, or imidafenacin (0.1 mg 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 50 mg and 100 mg 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 50 mg and 100 mg 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.

中文翻译：

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Vibegron，一种新型强效的选择性β ₃肾上腺受体激动剂，为患者治疗膀胱过动症：一项随机，双盲，安慰剂对照的3期研究

背景

Vibegron是一种新型的，有效的和选择性β ₃肾上腺素受体激动剂用于治疗患有膀胱过度活动症（OAB）的治疗。

客观的

为了评估vibegron与安慰剂在日本OAB患者中的疗效和安全性。

设计，设置和参与者

OAB患者进入2周安慰剂磨合期。一旦确定合格（≥8排尿/ d和≥1尿急/ d或≥1尿失禁/ d），患者进入12周双盲治疗阶段。抗胆碱能的咪达芬那用作有效参考。

干涉

总共1232名患者被随机分配到四个12周治疗组之一：vibegron（每天50 mg或100 mg），安慰剂或imidafenacin（每天两次0.1 mg）。

成果测量和统计分析

主要终点是从基线到第12周的平均排尿次数/天。次要终点是OAB症状变量（尿急，尿急，尿失禁和夜尿症以及排尿量/排尿量的每日发作）相对于基线的变化。评估生活质量（QoL）和安全性。约束纵向数据分析模型用于疗效分析。

结果与局限性

口服vibegron 50 mg和100 mg持续12周的患者在主要和次要终点均较安慰剂有明显改善。排尿正常，尿急缓解，尿失禁和尿失禁正常的患者比例明显大于安慰剂。Vibegron显着改善了QoL，患者满意度很高。Vibegron 50 mg和100 mg的药物相关不良事件发生率分别为7.6％，5.4％，与安慰剂相似（5.1％），而低于伊达非那星（10.3％）。治疗仅为12周，需要长期研究。

结论

用vibegron进行的12周治疗对OAB患者有效且耐受性良好。

病人总结

这项随机研究表明，vibegron在临床上可用于治疗OAB患者。

试验注册JapicCTI-152936。http://www.clinicaltrials.jp/user/cteDetail.jsp。