Long-term safety and efficacy of the novel β3-adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study
Long-term safety and efficacy of the novel β3-adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study
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DOI：
10.1111/iju.13596
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发表时间：
2018-07-01
影响因子：
2.6
通讯作者：
Kurose, Takafumi
中科院分区：
文献类型：
--
作者：
Yoshida, Masaki;Kakizaki, Hidehiro;Kurose, Takafumi
ObjectivesTo evaluate the long-term safety and efficacy of vibegron 50 mg and 100 mg，a novel（3）-adrenoreceptor agonist，in Japanese patients with overactive bladder.MethodsThis is a 1-year，multicenter，open-label，non-controlled study.经过1周的观察期后，患者接受Vibegron治疗52周。结果169例患者中，118例（69.8%）使用Vibegron 50 mg治疗52周，51例（30.2%）使用Vibegron 100 mg治疗。Vibegron 50 mg组和Vibegron 100 mg组的药物相关不良事件发生率分别为18.1%（21/116）和11.8%（6/51）。最常见的药物相关不良事件为口干（3.0%）、残余尿量增加（3.0%）、便秘（2.4%）和膀胱炎（1.8%）。在第4周观察到膀胱过动症症状变量（每日平均排尿次数、尿急发作、尿急性尿失禁发作、尿失禁发作和夜间频率）较基线的统计学显著变化，并维持至第52周。对Vibegron 50 mg反应不佳的患者的病情通过将剂量增加到100 mg得到了很大改善。Vibegron改善了患者的生活质量，Vibegron治疗后患者满意度的比例较高。结论Vibegron长期（52周）治疗膀胱过度活动症是安全的，耐受性良好，有效的。
ObjectivesTo evaluate the long-term safety and efficacy of vibegron 50mg and 100mg, a novel (3)-adrenoreceptor agonist, in Japanese patients with overactive bladder.MethodsThis was a 1-year, multicenter, open-label, non-controlled study. After a 1-week observation phase, patients were treated with vibegron for 52weeks. When the efficacy was insufficient after an 8-week treatment with 50mg, the dose was increased to 100mg and maintained for an additional 44weeks.ResultsAmong a total of 169 patients receiving one or more doses of vibegron, 118 (69.8%) received vibegron 50mg for 52weeks, and the dose was increased to 100mg in 51 (30.2%) patients. The incidence of drug-related adverse events was 18.1% (21/116) in the vibegron 50mg group and 11.8% (6/51) in the vibegron 100mg group. Most frequent drug-related adverse events were dry mouth (3.0%), residual urine volume increased (3.0%), constipation (2.4%) and cystitis (1.8%). Statistically significant changes in overactive bladder symptom variables (daily means of micturitions, urgency episodes, urgency incontinence episodes, incontinence episodes and night-time frequency) from baseline were observed at week4 and maintained until week52. The condition of patients who did not respond well to vibegron 50mg was much improved by increasing the dose to 100mg. Vibegron improved the quality of life, and the proportion of patients' satisfaction after the treatment with vibegron was high.ConclusionsLong-term (52-week) treatment with vibegron is safe, well-tolerated and effective in patients with overactive bladder.