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 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%).
CONCLUSION: 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.