JAMA子刊:新药沙库巴曲缬沙坦治疗晚期HFrEF患者有效性不足

2022-01-18 MedSci原创 MedSci原创

沙库巴曲缬沙坦(诺欣妥)是近20年来唯一被最大规模心衰领域临床研究证实, 优于既往标准治疗的创新药物。

沙库巴曲缬沙坦(诺欣妥)是近20年来唯一被最大规模心衰领域临床研究证实, 优于既往标准治疗的创新药物。心衰领域全球最大规模的III期临床研究PARADIGM-HF显示,对比传统的金三角血管紧张素受体转换酶抑制剂(ACEI),沙库巴曲缬沙坦能显著降低射血分数降低的心衰(HFrEF)患者心血管死亡风险 20%、首次因心衰住院风险21%、全因死亡风险16%。

在中位随访 27 个月后,由于血管紧张素受体-脑啡肽酶抑制剂(ARNI)组患者明显获益,且已经达到预先设定的界值,数据监测委员会(DMC)一致认为中期数据已达到主要终点,研究提前终止。

目前,指南暂不赞成将沙库巴曲缬沙坦用于NYHA IV级HFrEF患者。为了评估在晚期心力衰竭、射血分数降低和最近出现NYHA IV级症状的患者中,比较使用沙库巴曲缬沙坦与缬沙坦的治疗差异,来自美国圣路易斯华盛顿大学医学系的专家开展了相关研究,结果发表在JAMA Cardiology杂志上。

这是一项双盲随机临床试验,共纳入335名晚期心衰患者。患者在推荐治疗的基础上,随机接受沙库巴曲缬沙坦(目标剂量,200mg,每日两次)或缬沙坦(目标剂量,160mg,每日两次)。主要结果比较在24周的治疗中,与基线相比,N端脑钠肽(NT-proBNP)的曲线下面积(AUC)。

结果显示,在纳入分析的335名患者中,245名男性(73%);平均(SD)年龄为59.4(13.5)岁。72名符合条件的患者(18%)在短暂的磨合期内无法耐受药物剂量,49名患者(29%)在试验的24周内中止了沙库巴曲缬沙坦。缬沙坦治疗组(n = 168)的NT-proBNP AUC中位数为1.19(IQR,0.91-1.64),而沙库巴曲治疗组(n = 167)的AUC为1.08(IQR,0.75-1.60)。

估计NT-proBNP AUC的变化比率为0.95(95% CI 0.84-1.08;P = .45)。与缬沙坦相比,沙库巴曲/缬沙坦治疗并没有改善存活时间、出院和无心衰事件的临床综合情况。除了沙库巴曲/缬沙坦治疗组非危及生命的高钾血症有统计学意义的增加(28 [17%] vs 15 [9%]; P = .04)之外,没有观察到安全问题。

本试验结果表明,对于晚期HFrEF患者患者,在降低NT-proBNP水平方面,沙库巴曲缬沙坦和缬沙坦之间没有统计学上的显著差异。

 

参考文献:

Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA Cardiol. 2022;7(1):17–25. doi:10.1001/jamacardio.2021.4567

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    2022-02-05 forvalen

    学习了

    0

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    2022-01-18 诗冰

    非常好

    0

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