阿斯利康表示Farxiga达到了III期心力衰竭研究的主要终点

2022-05-09 Allan MedSci原创

一线结果显示,SGLT2抑制剂与心血管(CV)死亡或心力衰竭恶化的主要复合终点显著降低相关。

心力衰竭(HF)是一种慢性、长期的疾病,会随着时间的推移而恶化。它影响全球近 6400 万人,并与大量发病率和死亡率相关。有几个主要类别的 HF 与射血分数 (EF) 相关,这是衡量每次心脏收缩时离开心脏的血液百分比,包括:EF 降低的 HF (HFrEF)(LVEF 小于或等于 40%)、EF 轻度降低的 HF (HFmrEF) (LVEF 41-49%) 和 EF 保留的HF (HFpEF) (LVEF 大于或等于 50%)。大约一半的 HF 患者 EF 轻度降低或保留,几乎没有可用的治疗选择。Farxiga 已经被批准用于治疗 2 型糖尿病 (T2D)、HFrEF 和慢性肾脏病 (CKD) 相关的适应症。

阿斯利康近日表示,Farxiga(达格列净)在射血分数轻度降低或保留的心力衰竭患者中的​​ III 期 DELIVER 研究达到了其主要终点。一线结果显示,SGLT2抑制剂与心血管(CV)死亡或心力衰竭恶化的主要复合终点显著降低相关。

阿斯利康生物制药研发执行副总裁 Mene Pangalos 指出:“突破性的结果与 DAPA-HF 试验的结果相结合,表明 Farxiga 可有效治疗心力衰竭,且无论射血分数如何”。在 DAPA-HF 研究中,发现在标准治疗中加入 Farxiga 可显著降低射血分数降低 (HFrEF) 患者 CV 死亡和心力衰竭恶化的发生率。

DELIVER 试验招募了 6263 例左心室射血分数 > 40% 的心力衰竭患者,无论其处于何种 2 型糖尿病状态。参与者被随机分配接受 Farxiga 每天一次或安慰剂,两者都与背景治疗相结合。该研究的主要终点是首次发生 CV 死亡、因心力衰竭住院或紧急心力衰竭就诊的时间,而次要终点包括心力衰竭事件总数和 CV 死亡等。

 

原始出处:

https://firstwordpharma.com/story/5564037

评论区 (8)
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    2022-10-15 juliusluan78

    #III#

    0

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    2022-08-15 zhangj7108
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    2022-05-11 mhzhuang@stu.e

    #Farxiga#

    0

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    2022-05-11 yibei

    #IgA#

    0

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    2022-05-11 智智灵药

    #III期#

    0

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    2022-05-10 ms6000000960504356

    #学习#

    0

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    2022-05-10 ms6000000960504356

    不错

    0

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    2022-05-09 ms5000000518166734

    学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习学习

    0

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