达格列净III期DAPA-CKD研究因在慢性肾脏病患者中的压倒性疗效而计划提前终止

2020-04-01 小M MedSci原创

达格列净是首个在伴或不伴2型糖尿病的慢性肾脏病患者中展现出重大获益的SGLT2抑制剂

根据独立数据监测委员会(DMC)的建议,基于达格列净对慢性肾脏病患者有明确的“压倒性疗效”,达格列净预防慢性肾脏病患者不良结局(DAPA-CKD)的III期研究提前终止。

研究的疗效和安全性的常规评估中,达格列净的获益比预期更早出现,因此该临床研究被建议终止,阿斯利康随后也将启动研究的结束工作。

阿斯利康生物制药研发执行副总裁Mene Pangalos表示:“慢性肾脏病患者的治疗选择通常很有限,尤其是对那些不伴2型糖尿病的患者来说。我们非常高兴数据监测委员会认可了接受达格列净治疗的患者能获得“压倒性疗效” 的结论。在这一背景下,达格列净有望革新慢性肾脏病疾病管理理念,让全球患者获益。”

该临床研究的执行委员会联合主席,伦敦大学学院David Wheeler教授和格罗宁根大学医学中心的Hiddo L. Heerspink教授指出: “我们很荣幸能参与这项研究,并看到数据监测委员会的积极建议。我们非常期待与医学界和慢性肾脏病患者共同分享这一结果。”

DAPA-CKD研究的主要终点是由肾功能恶化或死亡组成的复合终点(定义为估算的肾小球滤过率持续下降50%,进展为终末期肾脏疾病或者出现心血管疾病或肾性死亡),不论患者是否伴有2型糖尿病。

该研究的完整数据将在一个近期召开的医学会议上提交并公布。阿斯利康也将立即与各国卫生监管机构沟通,就提前递交注册文件进行讨论。

2019年8月,美国食品药品监督管理局(FDA)鉴于达格列净可延缓慢性肾脏病患者的肾衰衰竭进展,以及可预防心血管死亡或肾性死亡,授予了达格列净快速审批通道的资格。据悉,达格列净用于心衰患者治疗的适应症正在接受FDA的优先审核,以及欧洲药品管理局(EMA)和其他地区监管机构的审核。

— 完 —


关于DAPA-CKD

DAPA-CKD是一项国际性多中心随机双盲研究,共纳入4,245例患者,旨在评估与安慰剂相比,10mg达格列净对于伴或不伴2型糖尿病的慢性肾脏病 2-4期尿白蛋白升高患者的疗效。在标准治疗的基础上,每天给予达格列净一次。 主要的复合终点是肾功能恶化(定义为肾小球滤过率下降≥50%,出现终末期肾脏疾病或者心血管或肾脏原因导致死亡)。 该研究正在21个国家开展。 在研究方案和DMC章节中的因有效性终止指南规定,在评估了所有可用的有效性和安全性数据后, DMC有权基于压倒性的疗效考虑提出中止研究的建议。

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    2020-08-27 juliusluan78
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    2020-04-01 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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