FDA Approved Drugs » 2012
Medical Areas: Cardiology/Vascular Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Amarin Pharmaceuticals
Approval Status: Approved July of 2012
Treatment Area: hypertriglyceridemia
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.
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.
FDA ApprovalThe 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.
Adverse events associated with the use of Vascepa may include, but are not limited to, the following:
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 ß-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.
Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients With Persistent High Triglycerides (from the ANCHOR Study). The American Journal of Cardiology 2012 Jul 20
Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). The American Journal of Cardiology 2011 Sep 1;108(5):682-90
For additional information regarding Vascepa or hypertriglyceridemia, please visit the Vascepa web page.