General Information

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA). EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles.

Vascepa is specifically approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (=500 mg/dL) hypertriglyceridemia.

Mechanism of Action

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA). EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased beta-oxidation; inhibition of acyl-CoA:diacylglycerol acyltransferase 1 and 2 (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.

Side Effects

Adverse events associated with the use of Vascepa may include, but are not limited to, the following:

• arthralgia

Dosing/Administration

Vascepa is supplied as a tablet for oral administration. The recommended dose is 4 grams per day taken as two capsules twice daily with food.

Clinical Trial Results

The FDA approval of Vascepa was based on a randomized, placebo-controlled, double-blind, parallel-group study in 151 subjects with severe hypertriglyceridemia. Baseline TG levels were between 500 and 2,000 mg/dL. The subjects received Vascepa 4mg per day for 12 weeks. Vascepa significantly reduced median TG (p< 0.001), VLDL-C (p< 0.05) and Apo B (p< 0.05) levels from baseline relative to placebo.