添加或切换到vibegron在患者的膀过度活跃不充分响应最初的4周抗肌糖药:一个随机,平行组,多中心试验 (ADVISR) 协议
Takanobu Yamamoto1, Soichiro Yoshida2, Yuya Maezawa3
1Urology, Tokyo Metropolitan Tama-Nambu Chiiki Hospital, Tama, Tokyo, Japan.
这项研究比较了将vibegron添加到抗肌肉类药物与在过度活性膀 (OAB) 患者中切换到vibegron. 结果将为不充分的抗肌肉素反应的治疗策略提供信息.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 过度活性膀 (OAB) 显著影响生活质量,其特点是急性,频率和夜尿.
- 抗肌肉癌药物和β-3受体agonists是OAB症状的主要治疗方法.
- 有限的证据表明,对抗肌肉抗药物反应不足的管理方法是有限的,特别是与涉及vibegron的组合疗法.
研究的目的:
- 为了评估vibegron添加到现有的抗肌糖药疗法的疗效,与转换到vibegron单一疗法在OAB患者.
- 为了比较12周期间两种治疗策略之间的每日尿动频率的变化.
主要方法:
- 一个随机的,开放的,平行组的多中心试验在日本,涉及110名OAB患者.
- 对4周抗穆斯卡林治疗反应不足的患者被随机分配 (1:1) 给添加vibegron组或切换到vibegron组.
- 主要终点是12周内每日尿动频率变化的跨组比较,使用贝叶斯混合模型分析重复测量以确认非劣等性.
主要成果:
- 主要分析的目的是确认转换组与附加组相比,转换组的非劣势.
- 非劣势性被定义为80%或更大的后面概率,即尿动频率变化的差异在特定的范围内.
结论:
- 这项试验将提供关于vibegron在OAB患者的有效性的关键证据,这些患者对抗肌肉抗药物反应不足.
- 结果将指导临床决策,以优化OAB治疗策略,可能提供新的治疗选择.
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