Efficacy and Safety of Combination of Prescription Omega-3 (Omacor~R) Added to Stable Statin Therapy in Hypertriglyceridemic Subjects: The COMBOS Trial

摘要

Elevated serum triglycerides (TGs) are often associated with elevated non-high-density lipoprotein cholesterol (non-HDL-C). The National Cholesterol Education Program Third Adult Treatment Panel (NCEP ATP III) identifies non-HDL-C as a secondary therapeutic target in patients with high TGs, but treatment goals may not be reached with statin monotherapy. This study assessed whether the addition of prescription omega-3-acid ethyl esters (P-OM3) to stable statin therapy can further improve non-HDL-C and other lipid variables in subjects with persistent hypertriglyceridemia. Multicenter, randomized, double-blind, placebo-controlled. 8-week lead-in phase during which subjects followed the Therapeutic Lifestyle Changes diet and received simvastatin 40 mg/d. Eligible subjects (TGs 200-499 mg/dL and LDL-C <=10% of NCEP ATP III goal) then continued open-label simvastatin 40 mg/d and were randomized to also receive either 4 g P-OM3 (Omacor~R, 3.4 g EPA+DHA) or placebo for 8 weeks.