一种用于治疗高甘油三酯血症的新型纯ω-3二十碳五烯酸乙酯（AMR101）：MARINE试验。
A new pure ω-3 eicosapentaenoic acid ethyl ester (AMR101) for the management of hypertriglyceridemia: the MARINE trial.
作者信息
Jacobson Terry A
机构信息
Department of Medicine, Office of Health Promotion and Disease Prevention, Emory University, Atlanta, GA, USA.
出版信息
Expert Rev Cardiovasc Ther. 2012 Jun;10(6):687-95. doi: 10.1586/erc.12.56.
ω-3 fatty acids reduce triglyceride (TG) levels, but corresponding increases in low-density lipoprotein cholesterol (LDL-C) levels may compromise achievement of lipid goals in patients with elevated cardiovascular risk. AMR101 is an investigational agent containing ≥96% of pure icosapent ethyl (the ethyl ester of eicosapentaenoic acid). The Phase III Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study with an Open-Label Extension (MARINE) investigated the efficacy and safety of AMR101 in 229 patients with very high TG levels (≥500 mg/dl). AMR101 4 g/day significantly reduced median placebo-adjusted TG levels from baseline by 33.1% (p < 0.0001), and AMR101 2 g/day reduced TG levels by 19.7% (p = 0.0051). Changes in LDL-C were minimal and nonsignificant. AMR101 may offer substantial TG lowering without increases in LDL-C levels.
ω-3脂肪酸可降低甘油三酯（TG）水平，但低密度脂蛋白胆固醇（LDL-C）水平相应升高可能会影响心血管风险升高患者实现血脂目标。AMR101是一种研究用药物，含有≥96%的纯二十碳五烯酸乙酯（二十碳五烯酸的乙酯）。III期多中心、安慰剂对照、随机、双盲、为期12周并带有开放标签延长期的研究（MARINE）调查了AMR101对229名高甘油三酯水平（≥500 mg/dl）患者的疗效和安全性。每天服用4克AMR101可使安慰剂调整后的TG中位数水平较基线显著降低33.1%（p < 0.0001），每天服用2克AMR101可使TG水平降低19.7%（p = 0.0051）。LDL-C的变化极小且无统计学意义。AMR101可能在不升高LDL-C水平的情况下大幅降低TG水平。
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