ATHEROSCLEROSIS PREVENTION IN PEDIATRIC LUPUS ERYTHEMATOSUS (APPLE)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research study is being done to find out whether or not a drug called atorvastatin, also known as Lipitor¿, will lower cholesterol levels, decrease inflammation, and lessen heart, stroke and circulatory problems in children with SLE between the ages of 10 through 21 years. Many people with SLE have high levels of lipids (fats) in their blood. Cholesterol is a special type of blood lipid. When blood vessels become hardened, inflamed (thickening of the walls of the vessel) and blocked by these fats, this condition is called atherosclerosis. Adults with SLE are at especially high risk for developing atherosclerosis. Atherosclerosis can occur in people with SLE even if they do not have high cholesterol levels in their blood. Atherosclerosis increases the risk of heart attack, stroke, problems with circulation, and may shorten one's life. Atorvastatin belongs to a family of drugs called 'statins' which are cholesterol lowering medications. These drugs have been proven to reduce cholesterol levels, slow the process of atherosclerosis and improve quality and length of life in adults with high blood cholesterol levels. Atorvastatin has been approved by the United States Food and Drug Administration (FDA) to treat high cholesterol in adults. Atorvastatin was recently approved by the FDA to treat children with dangerously high cholesterol caused by an inherited disease. It is not approved for use in children with normal cholesterol levels or in those with SLE, or other conditions. This study will test whether or not Atorvastatin will work better than a placebo (sugar pill) that looks like the study drug but has no effect on the body) at slowing the process of atherosclerosis in children with normal and abnormal cholesterol levels and adolescents with SLE when used with other cholesterol-lowering strategies.