ACC 2014:多研究证明Evolocumab降脂的有效性

2014-03-31 高晓方 译 医学论坛网

2014年美国心脏病学会年会(ACC2014)公布的三项临床试验表明,PCSK9单克隆抗体Evolocumab可有效降低高脂血症患者的低密度脂蛋白胆固醇(LDL-C),并且具有较好的安全性。 DESCARTES试验共纳入901例经降脂治疗后LDL-C ≥ 75 mg/dL的受试者,并按照2:1比率随机分入evolocumab(420 mg 皮下注射 1次/月)或安慰剂组。结果显示,evolocu

2014年美国心脏病学会年会(ACC2014)公布的三项临床试验表明,PCSK9单克隆抗体Evolocumab可有效降低高脂血症患者的低密度脂蛋白胆固醇(LDL-C),并且具有较好的安全性。

DESCARTES试验共纳入901例经降脂治疗后LDL-C ≥ 75 mg/dL的受试者,并按照2:1比率随机分入evolocumab(420 mg 皮下注射 1次/月)或安慰剂组。结果显示,evolocumab组的LDL-C最小均方平均值较安慰剂组降低57%,但依据背景降脂治疗不同存在较大变异。在12和52周时LDL-C的降低幅度基本相当。该研究论文发表于《新英格兰医学杂志》(简称NEJM)。

MENDEL-2试验共纳入614例未应用他汀类的高胆固醇血症患者,并对evolocumab和安慰剂或依折麦布进行了比较评估。结果显示,与安慰剂或依折麦布相比,evolocumab(140 mg/两周或420 mg/月)在12周期间可快速且显著的降低LDL水平;至基线LDL-C降低幅度分别比安慰剂和依折麦布升高55~57%和38~40%。该研究论文3月29日在线发表于《美国心脏病学杂志》(JACC)。

多中心RUTHERFORD-2试验共纳入331例家族性高胆固醇血症患者,随机给予evolocumab(140 mg/两周或420 mg/月)或安慰剂治疗12周。结果显示,在应用或未应用依折麦布的情况下evolocumab均可显著降低LDL-C。12周时,140 mg/两周和420 mg/月evolocumab组患者的LDL-C平均分别降低61%和56%。两种剂量evolocumab具有临床等效性。


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    2014-04-01 snf701207
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    2014-04-09 58.22.4.82

    Evolocumab什么时候进入中国

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