Icosapent ethyl 1g; soft gelatin capsules.
Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. Limitations of use: The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). Studies suggest that eicosapentaenoic acid 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.
The effects of Vascepa 4g per day were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients (76 on Vascepa, 75 on placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500 and 2,000mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C levels in these patients were 684mg/dL and 86mg/dL, respectively. Median baseline HDL-C level was 27mg/dL. The randomized population in this study was mostly Caucasian (88%) and male (76%). The mean age was 53 years and the mean body mass index was 31kg/m2. Twenty five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750mg/dL.
At endpoint, patients treated for 12 weeks with the 4g dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4g per day also showed statistically significant placebo-adjusted median reductions from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) of 18%, total cholesterol (TC) of 16%, very low density lipoprotein cholesterol (VLDL-C) of 29%, and apolipoprotein B (ApoB) of 9%. Among the patients with a baseline TG level>750mg/dL, Vascepa 4g/day reduced the placebo-corrected median TG levels by 45% (p<0.001).
Swallow whole. Do not crush, dissolve, or chew. 2 capsules twice daily with food; maximum 4g per day.
Obtain baseline lipids before initiating therapy. Identify other causes of high triglycerides and manage appropriately (eg, diabetes, hypothyroidism, or alcohol intake). Hepatic impairment; monitor ALT and AST levels periodically during therapy. Fish and/or shellfish allergy. Pregnancy (Category C). Nursing mothers.
Monitor periodically with concomitant drugs that affect coagulation (eg, antiplatelet agents).
To report suspected adverse reactions, contact Amarin Pharma at (855) 827-2372 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.