VASCEPA Rx

Indication(s):

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.

Pharmacology:

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.

Clinical Trials:

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).

Legal Classification:

Rx

Adults:

Swallow whole. Do not crush, dissolve, or chew. 2 capsules twice daily with food; maximum 4g per day.

Children:

Not established.

Warnings/Precautions:

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.

Interaction(s)

Monitor periodically with concomitant drugs that affect coagulation (eg, ­antiplatelet agents).

Adverse Reaction(s)

Arthralgia.

Notes:

To report suspected adverse reactions, contact Amarin Pharma at (855) 827-2372 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

How Supplied:

Caps—120

LAST UPDATED:

2/4/2013