A multicenter, double-blind, placebo-controlled, randomized clinical trial concluded that among patients with angiographic coronary disease treated with statins, addition of evolocumab, compared with placebo, resulted in more atheroma regression after 76 weeks of treatment. The trial enrolled 968 patients (mean age, 59.8 years; 269 women; mean LDL-C level, 92.5 mg/dL) between 05/03/2013 to 01/12/2015; 846 had evaluable imaging by intravascular ultrasound at follow-up. Monthly evolocumab (420 mg) (n = 484) or placebo (n = 484) was administered subcutaneously for 76 weeks, in addition to statins. Compared with placebo, the evolocumab group achieved lower mean, time-weighted LDL-C levels (93.0 vs 36.6 mg/dL). The primary efficacy parameter, percent atheroma volume, increased 0.05% with placebo and decreased 0.95% with evolocumab. The secondary efficacy parameter, normalized total atheroma volume, decreased 0.9 mm3 with placebo and 5.8 mm3 with evolocumab. Evolocumab induced plaque regression in a greater percentage of patients than placebo. The trial provides evidence that PCSK9 inhibition produces incremental benefits on coronary disease progression in statin-treated patients. Source: http://jamanetwork.com/
多中心，双盲，安慰剂对照，随机化临床试验得出结论，在使用他汀类药物的冠心病患者中，与安慰剂相比，加用evolocumab (前蛋白转化酶枯草杆菌蛋白酶/可欣9型抑制剂)治疗76周后导致更多的动脉粥样硬化消退。该试验在2013年5月至2015元月间纳入968例患者（平均年龄，59.8岁; 269名妇女; 平均低密度脂蛋白胆固醇水平，92.5毫克 / 分升）。随访时846例有可评估的血管内超声成像。除了他汀类药物外，每月一次evolocumab（420毫克，n = 484）或安慰剂（n = 484）皮下给药76周。与安慰剂相比，evolocumab组平均及时间加权的低密度脂蛋白胆固醇水平较低（93.0和36.6 毫克 / 分升）。主要疗效指标，动脉粥样硬化体积百分比，用安慰剂增加了0.05％，用evolocumab减少了0.95％。次要疗效指标，校正的总动脉粥样硬化容积，用安慰剂降低了0.9立方毫米，用evolocumab降低5.8立方毫米。 Evolocumab较安慰剂导致更大百分比患者的斑块退化。该试验为抑制前蛋白转化酶枯草杆菌蛋白酶/可欣9型对他汀类药物治疗患者冠心病进展的疗效进一步增加提供了证据。 来源：http://jamanetwork.com/