Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies.
Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies.
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DOI：
10.1007/s40256-012-0002-3
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发表时间：
2013-02
期刊：
影响因子：
--
通讯作者：
Soni PN
中科院分区：
文献类型：
--
作者：
Bays HE;Ballantyne CM;Braeckman RA;Stirtan WG;Soni PN
Icosapent ethyl（IPE）是一种二十碳五烯酸乙酯的高纯度处方形式，经美国食品药品监督管理局批准，作为饮食的辅助治疗，用于降低重度（≥ 500 mg/dL）高甘油三酯血症成人患者的甘油三酯（TG）水平。除了降低TG的作用外，IPE还可降低非高密度脂蛋白胆固醇和载脂蛋白B水平，而不会显著增加极高TG水平≥ 500 mg/dL的患者（MARINE研究）和LDL-C控制良好且残余高TG水平200 - 500 mg/dL的患者（ANCHOR研究）的低密度脂蛋白胆固醇（LDL-C）。该分析检查了IPE对MARINE和ANCHOR患者炎症标志物的影响。MARINE（N = 229）和ANCHOR（N = 702）是III期、双盲研究，将高维生素血症患者随机分配至IPE 4 g/天、2 g/天或安慰剂组。该分析评估了代表不同阶段动脉粥样硬化炎症的标志物（如细胞间粘附分子-1（ICAM-1）、氧化低密度脂蛋白（Ox-LDL）、脂蛋白相关磷脂酶A2（Lp-PLA2）、白细胞介素-6（IL-6）和高敏C反应蛋白（hsCRP））较基线的中位安慰剂校正百分比变化。与安慰剂相比，IPE 4 g/天显著降低Ox-LDL（13%，p <0.0001，ANCHOR），Lp-PLA2（14%，p <0.001，MARINE; 19%，p <0.0001，ANCHOR）和hsCRP水平（36%，p <0.01，MARINE; 22%，p <0.001，ANCHOR），但没有显著改变ICAM-1和IL-6水平。在MARINE研究中，IPE 2 g/天未显著改变ICAM-1、Ox-LDL、Lp-PLA2、IL-6或hsCRP水平。此外，在ANCHOR研究中，与安慰剂相比，IPE 2 g/天显著降低了Lp-PLA2水平（8%，p <0.0001），但没有显著改变其他评估的炎症标志物的水平。与安慰剂相比，在高脂血症患者中，IPE 4 g/天显著降低Ox-LDL、Lp-PLA2和hsCRP水平。
Icosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved by the US Food and Drug Administration as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In addition to TG-lowering effects, IPE also reduces non-high-density lipoprotein cholesterol and apolipoprotein B levels without significantly increasing low-density lipoprotein cholesterol (LDL-C) in patients with very high TG levels ≥500 mg/dL (MARINE study) and in patients with well-controlled LDL-C and residually high TG levels 200–500 mg/dL (ANCHOR study). This analysis examined the effect of IPE on inflammatory markers in patients from MARINE and ANCHOR. MARINE (N = 229) and ANCHOR (N = 702) were Phase III, double-blind studies that randomized hypertriglyceridemic patients to IPE 4 g/day, 2 g/day, or placebo. This analysis assessed the median placebo-adjusted percentage change from baseline in markers representing various stages of atherosclerotic inflammation such as intercellular adhesion molecule-1 (ICAM-1), oxidized low-density lipoprotein (Ox-LDL), lipoprotein-associated phospholipase A2 (Lp-PLA2), interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hsCRP). Compared to placebo, IPE 4 g/day significantly decreased Ox-LDL (13 %, p < 0.0001, ANCHOR), Lp-PLA2 (14 %, p < 0.001, MARINE; 19 %, p < 0.0001, ANCHOR), and hsCRP levels (36 %, p < 0.01, MARINE; 22 %, p < 0.001, ANCHOR), but did not significantly change ICAM-1 and IL-6 levels. In the MARINE study, IPE 2 g/day did not significantly change ICAM-1, Ox-LDL, Lp-PLA2, IL-6, or hsCRP levels. Also, compared to placebo in the ANCHOR study, IPE 2 g/day significantly decreased Lp-PLA2 levels (8 %, p < 0.0001), but did not significantly change levels of other assessed inflammatory markers. Compared to placebo, in hypertriglyceridemic patients, IPE 4 g/day significantly decreased Ox-LDL, Lp-PLA2, and hsCRP levels.
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