"Amarin has worked closely with leading clinical experts and regulatory authorities to bring this important new prescription pure-EPA omega-3 therapy to patients with very high triglycerides," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Other approved products for treating very high triglycerides have long been associated with raising LDL-C – commonly called bad cholesterol. Vascepa is the first prescription medicine for VHTG that does not raise LDL-C while significantly reducing very high triglycerides and providing a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo. We expect this to be an important consideration in patient care as we educate physicians and other providers about the product."
About Vascepa ® (icosapent ethyl) Capsules
(icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.
(icosapent ethyl) is indicated for use in the United States as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The effect of Vascepa on the risk for pancreatitis or on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Amarin is currently conducting a cardiovascular outcomes study called REDUCE-IT. This study is designed to evaluate the efficacy of Vascepa in reducing major cardiovascular events in an at-risk patient population on statin therapy.
The only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
Vascepa bottle photo available here
About Severe (>500 mg/dL) Hypertriglyceridemia, or VHTG
Severe hypertriglyceridemia refers to a condition in which patients have very high (≥500 mg/dL) levels of triglycerides in the bloodstream. Amarin estimates that approximately 4 million people in the United States have VHTG. Official U.S. guidelines for the management of VHTG state that reducing triglyceride levels is the primary lipid treatment goal in patients with VHTG levels to reduce the risk of acute pancreatitis.
The American Heart Association Scientific Statement on Triglycerides and Cardiovascular Disease
(2011), triglycerides also provide important information as a marker associated with the risk for heart disease and stroke, especially when an individual also has low high-density lipoprotein cholesterol, or HDL-C (often referred to as "good" cholesterol), and elevated levels of LDL-C (often referred to as "bad" cholesterol).
1 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): Final Report. National Heart, Lung, and Blood Institute. Bethesda, MD: National Institutes of Health; September 2002. Publication No. 02-5215; Oh RC, Lanier JB. Management of hypertriglyceridemia. Am Fam Physician. 2007;75(9):1365-1371.