Prescription omega-3 acid ethyl esters plus simvastatin 20 and 80 mg: effects in mixed dyslipidemia

BACKGROUND: 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). OBJECTIVE: 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. METHODS: 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. RESULTS: P-OM3 + simvastatin 80 mg resulted ill 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%). CONCLUSION: These results suggest non-HDL-C, TG (both 50% to 60%), and HDL-C (-25%) concentrations, call be markedly improved by a combination of P-OM3 (4 g/day) and simvastatin (80 mg/day) ill Subjects with mixed dyslipidemia. (C) 2009 National Lipid Association. All rights reserved.