Lipid Disorders

Amarin's therapeutic focus is on lipid disorders, currently hypertriglyceridemia and mixed dyslipidemia.

Triglyceride is fat and, like cholesterol, is a type of lipid in the blood. Triglyceride is carried through the body with cholesterol, on the same lipoproteins. Hypertriglyceridemia refers to a condition in which patients have high levels of triglycerides in the bloodstream. Triglyceride levels provide unique information as a biomarker of heart health associated with the risk for cardiovascular disease.

We refer to mixed dyslipidemia as a condition in which patients have a combination of two or more lipid abnormalities, including elevated triglycerides and low levels of high-density lipoprotein cholesterol, or HDL-C (often referred to as "good" cholesterol), and/or elevated low-density lipoprotein cholesterol or LDL-C (often referred to as "bad" cholesterol). The risk of cardiovascular disease is thought to be higher when an individual has low HDL-C and elevated levels of LDL-C. Non-HDL cholesterol (Non-HDL-C) refers to all kinds of cholesterol other than HDL-C. Generally, a person's risk for cardiovascular disease is thought to be lower the lower that person's levels of non-HDL-C.[1]

Cardiovascular disease encompasses many different diseases with patients often suffering from multiple conditions. The risks of cardiovascular disease include heart attacks, strokes, and other cardiovascular events. A healthy diet and exercise are recommended to reduce the risk of cardiovascular disease. After diet and exercise, statin therapy is recommended as the standard of care to reduce the risk of cardiovascular disease. Statin therapy is primarily targeted at lowering high levels of LDL-C, a recognized surrogate for cardiovascular risk. In clinical studies, statin therapy reduces cardiovascular risk by approximately one third.[2] Thus, after statin therapy, there remains a large unmet clinical need for further reduction in cardiovascular risk.

Hypertriglyceridemia and mixed dyslipidemia are being studied for their potential links as causal factors for cardiovascular disease. Scientific evidence is currently inconclusive as to whether lowering triglyceride and non-HDL-C levels in patients who have mixed dyslipidemia and are treated with statin therapy ultimately reduces the risks associated with cardiovascular disease, such as a patient's risk of a having a heart attack or stroke.[3]

Events caused by cardiovascular disease are the leading cause of death and disability among men and women in Western societies. According to the American Heart Association's 2010 At-A-Glance Report, over 831,000 deaths in the United States were caused by heart disease and stroke, substantially more than the approximately 572,000 reported deaths caused by cancer.[4] It is estimated that total global pharmaceutical sales in the cardiovascular segment in 2010 were approximately $116.3 billion.[5]

It is estimated that approximately 40 million adults in the United States have high triglyceride levels ≥200mg/dL.[1,6,7] It is estimated that approximately 70 million adults in the United States have elevated triglyceride levels ≥150mg/dL.[6,8] In the United States, mean triglyceride levels have risen since 1976 in concert with the growing epidemic of obesity, insulin resistance, and type 2 diabetes mellitus (T2DM).[1,9] In contrast, mean LDL-C levels have receded due to aggressive pharmacologic and dietary therapy.[9] It is estimated that the worldwide number of people with high and elevated triglyceride levels is at least three times the levels in the United States.[9]

It is estimated that approximately 4 million adults in the United States have severe (≥500 mg/dL) hypertriglyceridemia.[1,6] Patients with severe hypertriglyceridemia are also thought to be at risk for pancreatitis, a potentially life-threatening condition.[10]

The effect of drugs and drug candidates under development at Amarin on the risks of cardiovascular disease and pancreatitis has not been determined. For more information about drugs developed by Amarin, please click here for full prescribing information. For more information about the drug development program at Amarin, please click here.

1 Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123:2292-2333.
2 National Cholesterol Education Program. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421.
3 Nordestgaard BG, Varbo, A. Triglycerides and cardiovascular disease. The Lancet.2014;384:626-635.
4 American Cancer Society. Cancer Facts & Figures 2011. Atlanta: American Cancer Society, 2011.
5 Urch Publishing. Cardiovascular Pharmaceutical Market Trends, 2007 to 2010. SKU URC1550232.
6 Christian JB, Bourgeois N, Nipes R, Lowe KA. Prevelance of severe (500 to 2000 mg/dL) hypertriglyceridemia in United States adults. Am J Cardiol. 2011;107:891-897.
7 Data on file. PSMR 120238. Bedminster, NJ: Amarin Pharma Inc. 2012.
8 Toth PP, Potter D, Ming EE. Prevalence of lipid abnormalities in the United States: the National Health and Nutrition Examination Survey 2003-2006 J Clin Lipidol. 2012:325-30.
9 Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999–2000. JAMA. 2002; 288: 1723–1727.
10 Pejic RN, Lee DT. Hypertriglyceridemia. J Am Board Fam Med. 2006:310-316.

This page was last updated on September 16, 2014.