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首页> 外文期刊>Journal of the American College of Cardiology >AMG 145, a monoclonal antibody against PCSK9, facilitates achievement of national cholesterol education program-adult treatment panel III low-density lipoprotein cholesterol goals among high-risk patients: An analysis from the LAPLACE-TIMI 57 trial (LDL-C assessment with PCSK9 monoclonaL antibody inhibition combined with statin thErapy-thrombolysis in myocardial infarction 57)
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AMG 145, a monoclonal antibody against PCSK9, facilitates achievement of national cholesterol education program-adult treatment panel III low-density lipoprotein cholesterol goals among high-risk patients: An analysis from the LAPLACE-TIMI 57 trial (LDL-C assessment with PCSK9 monoclonaL antibody inhibition combined with statin thErapy-thrombolysis in myocardial infarction 57)

机译：AMG 145是针对PCSK9的单克隆抗体，可促进高危患者中国家胆固醇教育计划-成人治疗小组III低密度脂蛋白胆固醇目标的实现：来自LAPLACE-TIMI 57试验的分析（使用PCSK9 monoclonaL进行LDL-C评估抗体抑制联合他汀类药物治疗心肌梗塞溶栓57）

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Objectives This study sought to define the ability of AMG 145, a monoclonal antibody directed against proprotein convertase subtilisin kexin type 9 (PCSK9), to enable subjects at high risk for major adverse cardiovascular events to achieve National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) parameters for low-density lipoprotein cholesterol (LDL-C) and other lipid goals. Background Many patients at high risk for adverse cardiovascular events are unable to achieve the NCEP-ATP III LDL-C goal of <70 mg/dl, even with high-potency statin therapy. Methods In 282 subjects from the LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy-Thrombolysis In Myocardial Infarction 57) trial at high risk according to NCEP-ATP III criteria, we compared the proportion of subjects achieving the NCEP-ATP III recommended LDL-C goal of <70 mg/dl across treatment arms. Other outcomes included the triple goals of LDL-C <70 mg/dl, non-high-density lipoprotein cholesterol (HDL-C) <100 mg/dl, and apolipoprotein B (ApoB) <80 mg/dl. Results During the dosing interval, more than 90% of subjects in both of the top dose groups every 2 weeks and every 4 weeks attained this lipid target over the dosing interval, with similar success rates for the triple lipid goal. Conclusions PCSK9 inhibition with AMG 145 enables high-risk patients to achieve established lipid goals. If this therapy demonstrates efficacy for reducing cardiovascular events with a favorable safety profile in ongoing phase 3 trials, we believe it will have major public health implications.
机译：目的本研究旨在确定AMG 145（一种针对原蛋白转化酶枯草杆菌蛋白酶kexin 9型（PCSK9）的单克隆抗体）的能力，以使处于重大心血管不良事件高风险的受试者能够达到国家胆固醇教育计划-成人治疗小组III（低密度脂蛋白胆固醇（LDL-C）和其他脂质目标的NCEP-ATP III）参数。背景技术即使使用高效他汀类药物治疗，许多具有不良心血管事件高风险的患者也无法达到<70 mg / dl的NCEP-ATP III LDL-C目标。方法根据NCEP-ATP III标准，在高风险的LAPLACE-TIMI 57（PCSK9单克隆抗体抑制结合他汀类药物治疗-溶栓治疗LDL-C评估，心肌梗死57）中的282名高风险受试者中，我们比较了达到目标的受试者的比例NCEP-ATP III建议各治疗组的LDL-C目标<70 mg / dl。其他结果包括LDL-C <70 mg / dl，非高密度脂蛋白胆固醇（HDL-C）<100 mg / dl和载脂蛋白B（ApoB）<80 mg / dl的三重目标。结果在给药间隔期间，每2周和每4周，在最高剂量组中，超过90％的受试者在给药间隔内达到了该脂质目标，三脂质目标的成功率相似。结论用AMG 145抑制PCSK9可使高危患者达到既定的脂质目标。如果这种疗法在正在进行的3期试验中显示出可降低心血管事件的疗效并具有良好的安全性，那么我们相信它将对公共卫生产生重大影响。

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