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[依洛尤单抗(瑞百安®):用于动脉粥样硬化疾病二级预防的高胆固醇血症新疗法]

[Evolocumab (Repatha®) : new therapy ofhypercholesterolaemia for secondary prevention of atherosclerotic disease].

作者信息

Scheen André, Wallemacq Caroline, Lancellotti Patrizio

机构信息

Service de Diabétologie, Nutrition et Maladies métaboliques, CHU Liège, Belgique.

Service de Cardiologie, CHU Liège, ULiège, Belgique.

出版信息

Rev Med Liege. 2023 Oct;78(10):593-600.

Abstract

Evolocumab is a monoclonal antibody that blocks PCSK9 («Proproteine Convertase Subtilisine/Kexine type 9»). It exerts a rapid, potent and sustained reduction of LDL cholesterol (LDL-c) levels in combination with statin therapy. It was first reimbursed for the treatment of familial hypercholesterolaemia. The FOURIER trial and its extension FOURIER-OLE among patients with atherosclerotic cardiovascular disease and residual hypercholesterolaemia despite statin therapy demonstrated that evolocumab significantly reduces the incidence of major cardiovascular adverse events (- 15 %, P <0.001). There was a monotonic relationship between the reduction in clinical events and the diminution of LDL-c levels even down to the lowest concentrations. The safety profile of evolocumab was excellent, also in patients with very low LDL-c levels. Because of these favorable results, evolocumab (Repatha®) is now reimbursed, under conditions, for the secondary prevention of atherosclerotic cardiovascular disease.

摘要

依洛尤单抗是一种可阻断前蛋白转化酶枯草溶菌素9型(PCSK9)的单克隆抗体。与他汀类药物联合使用时,它能快速、强效且持续地降低低密度脂蛋白胆固醇(LDL-c)水平。它最初被批准用于治疗家族性高胆固醇血症。 FOURIER试验及其在接受他汀类药物治疗但仍有残余高胆固醇血症的动脉粥样硬化性心血管疾病患者中的扩展试验FOURIER-OLE表明,依洛尤单抗可显著降低主要心血管不良事件的发生率(降低15%,P<0.001)。临床事件的减少与LDL-c水平的降低之间存在单调关系,即使降至最低浓度也是如此。依洛尤单抗的安全性良好,在LDL-c水平极低的患者中也是如此。由于这些良好的结果,依洛尤单抗(Repatha®)目前在一定条件下被批准用于动脉粥样硬化性心血管疾病的二级预防。

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