Abstract 5150: Effect of Prescription Omega-3 Fatty Acids Coadministered with Escalating Doses of Atorvastatin in Patients with Hypertriglyceridemia
Non-HDL-C is a secondary treatment target for patients with mixed dyslipidemia and persistent elevations in triglyceride (TG) levels. This study assessed the effects of prescription omega-3 fatty acids (P-OM3) when co-administered with escalating doses of atorvastatin (atorva) in subjects with baseline non-HDL-C >160 mg/dL and TG 250 –599 mg/dL. Multicenter, randomized, double-blind, placebo-controlled, parallel-group, 16 week (W) study. After a 4W diet lead-in, dyslipidemic subjects 18 –79 years of age received blinded P-OM3 (4 g/d) or placebo (PBO) + open-label atorva. The atorva dose was 10, 20, and 40 mg/d at W1– 8, W9 –12, and W13–16, respectively. Primary end point was the difference between groups in non-HDL-C based upon percent change from baseline (%CFB) at W8. Secondary end points included the difference between groups in %CFB for TC; HDL-C; LDL-C; TG; VLDL-C; apo A-I, B, and C-III; and lipoprotein-associated phospholipase A2 (Lp-PLA2) at W8. Investigators also assessed safety/tolerability. (table⇓) In addition to the significant reduction in non-HDL-C levels and improvement in secondary end points with atorva 10 mg/d, P-OM3 also significantly improved non-HDL-C and other efficacy parameters when co-administered with atorva 20 and 40 mg/d (not shown in table⇓). This study revealed no serious drug-related adverse experiences. When co-administered with varying doses of atorva, P-OM3 reduces non-HDL-C and improves other efficacy parameters.