ACC 2014:GAUSS-2研究:evolocumab或可用于他汀不耐受患者

2014-03-31 小田 译 医学论坛网

PCSK9单克隆抗体evolocumab在本次美国心脏病学会年会(ACC2014)上可谓是风头正猛,如29日报道的多中心RUTHERFORD-2研究、MENDEL-2研究和DESCARTES研究结果均为阳性。30日有关evolocumab的研究又闪亮登场,这项研究表明,在他汀类药物不耐受的高胆固醇血症高危人群的治疗方面,evolocumab是一种前景比较好的联合治疗方法。研究论文3月30日在线发表

PCSK9单克隆抗体evolocumab在本次美国心脏病学会年会(ACC2014)上可谓是风头正猛,如29日报道的多中心RUTHERFORD-2研究、MENDEL-2研究和DESCARTES研究结果均为阳性。30日有关evolocumab的研究又闪亮登场,这项研究表明,在他汀类药物不耐受的高胆固醇血症高危人群的治疗方面,evolocumab是一种前景比较好的联合治疗方法。研究论文3月30日在线发表于《美国心脏病学杂志》(J Am Coll Cardiol)。

GAUSS-2是一项为期12周的双盲试验,旨在评估他汀类药物不耐受患者应用PCSK9单克隆抗体的效果,研究者随机将患者以2:2:1:1的比例分为evolocumab 140 mg [2周一次(Q2W)]或evolocumab 420 mg[每月一次(QM)],两组均同时给予安慰剂(PBO)口服; 或皮下注射PBO (Q2W或QM),两组均给予依折麦布10 mg口服。主要终点为患者基线低密度脂蛋白胆固醇(LDL-C)至12周和平均10周、12周的变化。

结果显示,共307例患者(平均年龄为62岁,平均LDL-C为193 mg/dl)纳入随机化研究。Evolocumab对LDL-C水平的降幅为53-56%,相对依折麦布的治疗差异为37-39% (P < 0.001)。evolocumab治疗组和依折麦布治疗组患者肌肉不良事件发生率分别为12%和23%。各治疗组出现紧急治疗不良事件和实验室异常均相当。

evolocumab将会对其余两种降脂药(他汀类药物和依折麦布)有何影响?让我们拭目以待!


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    2014-09-19 snf701207
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