在过度活跃的膀中,埃利亚皮克桑的有效性和安全性:为期12周的随机对照,安慰剂控制的第二阶段OVADER研究
Flavio Ewerton1, Francisco Cruz2, Moritz Kapp1
1Bayer AG, Berlin, Germany.
在2a期研究中,Eliapixant是一种治疗过活性膀 (OAB) 的新疗法,与安慰剂相比,在减少急性尿失禁 (UUI) 发作方面没有显著的疗效. 需要对OAB病理生理学的进一步研究,以获得有效的治疗方法.
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:
- 过度活跃的膀 (OAB) 对有效和耐受良好的治疗方法存在重大未满足的需求.
- P2X3受体对抗剂eliapixant已经显示出用于OAB症状管理的临床前承诺.
研究的目的:
- 评估埃利亚皮克桑在被诊断为OAB和紧急尿失禁 (UUI) 的患者的安全性,耐受性和疗效.
主要方法:
- OVADER研究是一项为期12周的随机,双盲,安慰剂控制,多中心2a期试验.
- 参与者每天两次接受口服125毫克的eliapixant或安慰剂.
- 主要终点测量了12周内UUI发作/24小时的平均变化,使用贝叶斯重复测量模型进行分析.
主要成果:
- 埃利亚皮克桑药物没有达到初级疗效终点,未能显示与安慰剂相比,UUI发作有统计学意义的减少.
- 埃利亚皮克桑优势的概率为40%,低于预定义的90%门.
- 两组之间的不良事件发生率是可比的,大多数事件是轻微的.
结论:
- 在OVADER研究中得出的结论是,埃利亚皮克桑不符合OAB与UUI的临床疗效终点.
- 缺乏疗效的潜在因素包括复杂的OAB症状学和COVID-19大流行的影响.
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