Randomized studies showed that evolocumab and alirocumab, two monoclonal antibodies that inhibit proprotein convertase subtilisin–kexin type 9 (PCSK9) significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events. 4465 patients who had completed 1 of 12 phase 2 or 3 studies of evolocumab were randomly assigned in a 2:1 ratio to receive either evolocumab (140 mg every 2 weeks or 420 mg monthly) plus standard therapy or standard therapy alone. Patients were followed for a median of 11.1 months. As compared with standard therapy alone, evolocumab reduced the level of LDL cholesterol by 61% and cardiovascular outcomes by 53%. Most adverse events occurred with similar frequency in the two groups, although neurocognitive events were reported more frequently in the evolocumab group. 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated with an acceptable side-effect profile), with or without other lipid-lowering therapy were randomly assigned in a 2:1 ratio to receive alirocumab (150 mg) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks. Alirocumab reduced the level of LDL cholesterol by 62% and the rate of major adverse cardiovascular events was lower with alirocumab than with placebo (1.7% vs. 3.3%, post hoc analysis). The alirocumab group, as compared with the placebo group, had higher rates of injection-site reactions, myalgia, neurocognitive events, and ophthalmologic events. The new class of drug could be used for patients who have elevated cholesterol levels even after maximum-dose statin therapy, as well as for patients who are statin-intolerant. A systematic review and meta-analysis also suggest that PCSK9 inhibitors reduced all-cause mortality and cardiovascular mortality. Source: http://www.nejm.org/; http://annals.org/随机研究表明两种抑制枯草杆菌蛋白酶-可欣类型9前蛋白转化酶（PCSK9）的单克隆抗体，evolocumab和alirocumab，显著降低LDL胆固醇水平并降低心血管事件的发生率。 4465例已完成12个evolocumab 2或3期研究之1的病人按2：1的比例被随机分配接受evolocumab（每2个星期140毫克或每月420毫克），加上标准治疗或单独标准治疗。平均随访了11.1个月。与单独标准治疗相比，evolocumab降低LDL胆固醇水平61％，并降低心血管事件53％。两组大多数不良反应的发生率类似，虽然神经认知障碍在evolocumab组报告更为频繁。 2341名心血管病高危患者，LDL胆固醇水平每分升70毫克（每升1.8毫摩尔）或更高，并接受最大耐受剂量（可接受副作用下的最高剂量）他汀类药物治疗，无论有或无其他降脂治疗，经随机分配以2：1的比例接受alirocumab（150毫克）或安慰剂，每2周以1毫升皮下注射，共78周。 Alirocumab降低LDL胆固醇水平62％，且alirocumab组严重心血管事件的发生率比安慰剂组较低（1.7％对3.3％，事后分析）。alirocumab组，与安慰剂组相比，有注射部位反应，肌肉痛，神经认知事件和眼科事件的比率较高。该类新药可用于即使给予最大剂量他汀类药物治疗仍有高胆固醇，以及对他汀类药物不耐受的患者。一项系统综述和荟萃分析还提示，PCSK9抑制剂降低全因死亡率和心血管病死亡率。来源：http://www.nejm.org/; http://annals.org/
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