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FDA:Repatha——心血管疾病患者的福音来了

2015-08-29 chenshuo 译 MedSci原创

Repatha,其通用名称为Evolocumab,是无法控制低密度脂蛋白胆固醇(LDL-C)的高胆固醇血症患者目前的治疗用药。FDA建议,健康合理的饮食联合使用他汀类药物治疗杂合子家族性高胆固醇血症(heFH)患者,纯合子家族性高胆固醇血症(HoFH)患者或患动脉粥样硬化性心血管疾病(如心脏病发作或中风)的患者需要额外药物来降低LDL-C水平。HeFH和HoFH患者体内LDL-C高浓度是由于遗传因

Repatha,其通用名称为Evolocumab,是无法控制低密度脂蛋白胆固醇(LDL-C)的高胆固醇血症患者目前的治疗用药。


FDA建议,健康合理的饮食联合使用他汀类药物治疗杂合子家族性高胆固醇血症(heFH)患者,纯合子家族性高胆固醇血症(HoFH)患者或患动脉粥样硬化性心血管疾病(如心脏病发作或中风)的患者需要额外药物来降低LDL-C水平。

HeFH和HoFH患者体内LDL-C高浓度是由于遗传因素所致,且LDL-C水平过高会导致民众患心血管疾病的风险增加。据CDC数据,每年大约有735000名美国人会突发心脏病(美国民众死亡的主要原因),最常见的是患冠心病,每年有370000多位美国人因患冠心病死亡。

如今许多实验都在评估Repatha的有效性和安全性,包括一个为期52周的安慰剂对照实验和八个为期12周的安慰剂对照实验。其中两组实验的参与者患有HeFH,一个实验的参与者患有 HoFH。与使用安慰剂的对照组相比,服用Repatha的实验组患者LDL-C水平平均降低约60%。

Repatha是一种抑制PCSK9(枯草溶菌素转化酶9)活性的单克隆抗体。PCSK9是一种调节血浆LDL-C水平至关重要的蛋白质,它主要通过促进低密度脂蛋白受体(LDLR)在肝细胞内的降解,进而减少肝细胞表面LDLRs浓度,因此血浆中LDL-C水平升高。Repatha药物抑制PCSK9的活性,从而降低血LDL-C水平。

John Jenkins博士说道:“Repatha 药物为HeFH患者和无法降低LDL-C水平的心血管疾病患者提供了新的治疗用药。心血管疾病严重影响美国人的身体健康,这种药物的研发有助于解决这个难题。”

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    2015-08-31 gwc384
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    2015-08-31 mei538
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