Provident Clinical Research, 489 Taft Avenue, Glen Ellyn, IL 60137 USA.
J Clin Lipidol. 2009 Feb;3(1):33-8. doi: 10.1016/j.jacl.2008.12.007. Epub 2008 Dec 27.
Prescription omega-3 acid ethyl esters (P-OM3) plus simvastatin 20 and 40 mg/day improves lipids in subjects with mixed dyslipidemia, but no previous studies have examined P-OM3 with the maximum prescribed dose of simvastatin (80 mg).
To assess the effects of P-OM3 + simvastatin 80 mg versus P-OM3 + simvastatin 20 mg or placebo + simvastatin 20 mg on non-high-density lipoprotein cholesterol (non-HDL-C) and other lipid concentrations.
Subjects with mixed dyslipidemia who had completed a 12-week double-blind crossover study of simvastatin 20 mg/day + either placebo or P-OM3 4 g/day were enrolled. An analysis (n = 14) was performed following the first six weeks of the extension, during which all subjects received open-label P-OM3 + open-label simvastatin 80 mg/day.
P-OM3 + simvastatin 80 mg resulted in significantly larger reductions from baseline (P < .05 for all) versus P-OM3 + simvastatin 20 mg and placebo + simvastatin 20 mg, respectively, for non-HDL-C (-51.0%, -40.8%, -34.9%), low-density lipoprotein cholesterol (-48.0%, -35.5%, -38.0%), total cholesterol (TC) (-42.6%, -31.9%, -27.1%), the TC/HDL-C ratio (-52.9%, -44.3%, -36.2%), and apolipoprotein B (-42.6%, -32.6%, -30.5%). P-OM3 + simvastatin (80- and 20-mg doses, respectively) resulted in significantly larger changes from baseline (P < .05 for all) versus placebo in very low-density lipoprotein cholesterol (-50.7%, -47.9%, -23.0%), triglycerides (TG; -58.6%, -54.7%, -32.0%), HDL-C (24.5%, 20.7%, 17.9%), and the TG/HDL-C ratio (-66.5%, -62.3%, -42.5%).
These results suggest non-HDL-C, TG (both 50% to 60%), and HDL-C (∼25%) concentrations can be markedly improved by a combination of P-OM3 (4 g/day) and simvastatin (80 mg/day) in subjects with mixed dyslipidemia.
处方ω-3 酸乙酯（P-OM3）联合辛伐他汀 20 毫克和 40 毫克/天可改善混合性血脂异常患者的血脂，但尚无研究探讨 P-OM3 联合最大推荐剂量的辛伐他汀（80 毫克）。
评估 P-OM3+辛伐他汀 80 毫克与 P-OM3+辛伐他汀 20 毫克或安慰剂+辛伐他汀 20 毫克对非高密度脂蛋白胆固醇（非-HDL-C）和其他血脂浓度的影响。
完成辛伐他汀 20 毫克/天+安慰剂或 P-OM3 4 克/天双盲交叉研究的混合性血脂异常患者入组本扩展研究。在扩展研究的前 6 周（所有患者接受开放标签 P-OM3+开放标签辛伐他汀 80 毫克/天）后进行分析（n=14）。
与 P-OM3+辛伐他汀 20 毫克和安慰剂+辛伐他汀 20 毫克相比，P-OM3+辛伐他汀 80 毫克分别使非-HDL-C（-51.0%、-40.8%、-34.9%）、低密度脂蛋白胆固醇（-48.0%、-35.5%、-38.0%）、总胆固醇（TC）（-42.6%、-31.9%、-27.1%）、TC/高密度脂蛋白胆固醇（HDL-C）比值（-52.9%、-44.3%、-36.2%）和载脂蛋白 B（-42.6%、-32.6%、-30.5%）显著降低，差异均有统计学意义（P均<.05）。与安慰剂相比，P-OM3+辛伐他汀（80 毫克和 20 毫克剂量）使极低密度脂蛋白胆固醇（-50.7%、-47.9%、-23.0%）、甘油三酯（TG；-58.6%、-54.7%、-32.0%）、HDL-C（24.5%、20.7%、17.9%）和 TG/HDL-C 比值（-66.5%、-62.3%、-42.5%）显著降低，差异均有统计学意义（P均<.05）。
这些结果提示，在混合性血脂异常患者中，P-OM3（4 克/天）联合辛伐他汀（80 毫克/天）可使非-HDL-C、TG（50%~60%）和 HDL-C（约 25%）浓度显著改善。
