A new pure ω-3 eicosapentaenoic acid ethyl ester (AMR101) for the management of hypertriglyceridemia: the MARINE trial
A new pure ω-3 eicosapentaenoic acid ethyl ester (AMR101) for the management of hypertriglyceridemia: the MARINE trial
复制标题
DOI：
10.1586/erc.12.56
复制
发表时间：
2012-01-01
影响因子：
2
通讯作者：
Jacobson, Terry A.
中科院分区：
文献类型：
--
作者：
Jacobson, Terry A.
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）水平的相应升高可能会损害心血管风险升高患者血脂目标的实现。AMR 101是一种研究药物，含有>= 96%的纯二十碳五烯酸乙酯（二十碳五烯酸乙酯）。III期、多中心、安慰剂对照、随机、双盲、12周、开放标签扩展研究（MARINE）在229例TG水平极高（>= 500 mg/dl）患者中研究了AMR 101的疗效和安全性。AMR101 4 g/天使安慰剂校正的TG水平中位数较基线显著降低33.1%（p <0.0001），AMR101 2 g/天使TG水平降低19.7%（p = 0.0051）。LDL-C的变化极轻微且不显著。AMR101可显著降低TG而不增加LDL-C水平。
omega-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.