依洛尤单抗对心血管事件的影响。
Effects of Evolocumab on Cardiovascular Events.
作者信息
Mikhail Nasser
机构信息
OliveView-UCLA Medical Center, David-Geffen Medical School, Los Angeles, California, 14445 Olive View Dr, Sylmar, CA 91342. United States.
出版信息
Curr Cardiol Rev. 2017;13(4):319-324. doi: 10.2174/1573403X13666170918165713.
BACKGROUND
Evolocumab is a potent lipid-lowering drug that decreases plasma levels of lowdensity lipoprotein cholesterol (LDL-C) by 50-60%. FOURIER is a landmark randomized trial involving 27,564 patients with established cardiovascular disease already on statins and plasma LDLC levels > 70 mg/dl.
OBJECTIVE
The main objective of FOURIER was to examine the effects of evolocumab on cardiovascular events.
RESULTS
After a mean follow-up of 2.2 years, evolocumab significantly decreased the primary endpoint (composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) by 15% compared to placebo [hazard ratio 0.85 (95% CI, 0.79-0.92)], but no significant effect was found on mortality. The most common adverse effect of evolocumab was mild injection site reaction occurring in 2.1% of patients versus 1.6% of patients receiving placebo.
CONCLUSION
These results support the use of evolocumab as add-on therapy to statins for high cardiac- risk patients not achieving optimal goals of LDL-C. Longer-term studies are needed to further clarify the efficacy and safety of evolocumab.
背景
依洛尤单抗是一种强效降脂药物，可使血浆低密度脂蛋白胆固醇（LDL-C）水平降低50%-60%。FOURIER是一项具有里程碑意义的随机试验，涉及27564例已服用他汀类药物且血浆LDL-C水平>70mg/dl的确诊心血管疾病患者。
目的
FOURIER的主要目的是研究依洛尤单抗对心血管事件的影响。
结果
平均随访2.2年后，与安慰剂相比，依洛尤单抗使主要终点（心血管死亡、心肌梗死、中风、不稳定型心绞痛住院或冠状动脉血运重建的复合终点）显著降低了15%[风险比0.85（95%CI，0.79-0.92）]，但未发现对死亡率有显著影响。依洛尤单抗最常见的不良反应是轻度注射部位反应，发生在2.1%的患者中，而接受安慰剂的患者中这一比例为1.6%。
结论
这些结果支持将依洛尤单抗作为未达到LDL-C最佳目标的高心脏风险患者他汀类药物的附加治疗。需要进行长期研究以进一步阐明依洛尤单抗的疗效和安全性。
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