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

BackgroundPrescription 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).ObjectiveTo 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.MethodsSubjects 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.ResultsP-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%).ConclusionThese 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.