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CORONARY HEART DISEASE

Almost one million Americans die each year from coronary heart disease (“CHD”), mainly from heart attack and stroke. Cardiovascular diseases cause 38% of deaths in North America alone. Elevated blood cholesterol is a major risk factor for CHD, and that risk can be reduced by lipid-lowering therapy. Cholesterol-lowering drugs, called statins, are the industry’s bestsellers for managing CHD. Cholesterol-lowering medicines alone account for $22 billion in 2002 sales. The global statin market has experienced very strong growth, with worldwide sales of $25 billion in 2006. Statins are the most prescribed because they are effective in lowering total cholesterol and low-density lipoprotein cholesterol (LDL).

Arteriosclerosis underlies most coronary artery disease, which is a slowly progressive disease that begins with the accumulation of cholesterol within the arterial wall. Low-density lipoprotein cholesterol (LDL) becomes trapped within the vascular wall leading to the formation of foam cells. This accumulation eventually forms bulky plaques and when the plaque breaks off, it leads to blood clots that cause heart attacks and strokes, which is the leading cause of death in industrialized countries.

While LDL (a.k.a. “bad cholesterol”) is responsible for the delivery of cholesterol from the liver to tissues in the body, there’s another cholesterol carrier called the high-density lipoprotein cholesterol (HDL). HDL is also known as “good cholesterol” because it transports cholesterol from the tissues of the body back to the liver where it is degraded and eliminated thus protecting against the developments of arteriosclerosis.

Recent studies now show that the incidence of CHD decreases with increasing HDL levels; the risk of CHD decreases by half for each 20-mg/dL increase of HDL. In populations with low CHD incident, average values of Total C/HDL ratios are below 4.0. In this regard, the National Cholesterol Education Program (“NCEP”) treatment guidelines, although recognizing LDL as the primary target of therapy for prevention, now focus on HDL levels as a major risk factor. The Adult Treatment Panel (ATP) of NCEP has now raised the HDL lower limit from 35 mg/dL to 50 mg/dL.