Maki Kevin C, McKenney James M, Reeves Matthew S, Lubin Barry C, Dicklin Mary R
Provident Clinical Research, Glen Ellyn, Illinois, USA.
Am J Cardiol. 2008 Aug 15;102(4):429-33. doi: 10.1016/j.amjcard.2008.03.078. Epub 2008 May 22.
Prescription omega-3 acid ethyl esters (P-OM3) are commonly used for treatment of very high triglyceride levels, often in combination with a statin, to lower persistent hypertriglyceridemia. This randomized, crossover trial evaluated 6 weeks of combination therapy with simvastatin 20 mg/day plus P-OM3 4 g/day or placebo in 39 men and women (average age 58 years) with a triglyceride concentration 200 to 600 mg/dl and non-high-density lipoprotein (non-HDL) cholesterol greater than their National Cholesterol Education Program treatment goals after a 5-week diet lead-in. Non-HDL cholesterol decreased from baseline (209 mg/dl) by 40% for P-OM3 + simvastatin compared with 34% for placebo + simvastatin (p <0.001). Favorable changes for P-OM3 + simvastatin versus placebo + simvastatin were also observed for very low-density lipoprotein (VLDL) cholesterol (-42% vs -22%), triglyceride (-44% vs -29%), total cholesterol (-31% vs -26%), HDL cholesterol (+16% vs +11%), apolipoprotein B (-32% vs -28%), total cholesterol:HDL cholesterol ratio (-39% vs -33%), triglyceride:HDL cholesterol ratio (-51% vs -37%), and systolic (-5.0 vs 0.3 mm Hg) and diastolic (-3.3 vs -1.8 mm Hg) blood pressures (p <0.05 for all). VLDL particle concentration and size decreased and LDL particle size increased significantly more with P-OM3 + simvastatin than with placebo + simvastatin (all p <0.05). Changes in LDL cholesterol, LDL particle concentration, HDL particle size and concentration, and apolipoprotein A-I did not differ significantly between treatments. In conclusion, P-OM3 + simvastatin appears to be a useful therapeutic option for the management of mixed dyslipidemia.
处方用ω-3酸乙酯（P-OM3）通常用于治疗极高的甘油三酯水平，常与他汀类药物联合使用，以降低持续性高甘油三酯血症。这项随机交叉试验评估了39名男性和女性（平均年龄58岁）在经过5周饮食导入期后，甘油三酯浓度为200至600mg/dl且非高密度脂蛋白（non-HDL）胆固醇高于其国家胆固醇教育计划治疗目标的患者，给予辛伐他汀20mg/天加P-OM3 4g/天或安慰剂联合治疗6周的效果。与安慰剂+辛伐他汀组相比，P-OM3+辛伐他汀组的非HDL胆固醇从基线水平（209mg/dl）降低了40%，而安慰剂+辛伐他汀组降低了34%（p<0.001）。与安慰剂+辛伐他汀组相比，P-OM3+辛伐他汀组在极低密度脂蛋白（VLDL）胆固醇（-42%对-22%）、甘油三酯（-44%对-29%）、总胆固醇（-31%对-26%）、高密度脂蛋白（HDL）胆固醇（+16%对+11%）、载脂蛋白B（-32%对-28%）、总胆固醇：HDL胆固醇比值（-39%对-33%）、甘油三酯：HDL胆固醇比值（-51%对-37%）以及收缩压（-5.0对0.3mmHg）和舒张压（-3.3对-1.8mmHg）方面也观察到有利变化（所有p<0.05）。与安慰剂+辛伐他汀组相比，P-OM3+辛伐他汀组的VLDL颗粒浓度和大小显著降低，LDL颗粒大小显著增加（所有p<0.05）。治疗组之间低密度脂蛋白胆固醇、低密度脂蛋白颗粒浓度、高密度脂蛋白颗粒大小和浓度以及载脂蛋白A-I的变化无显著差异。总之，P-OM3+辛伐他汀似乎是治疗混合性血脂异常的一种有效治疗选择。
