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The Cholesterol Connection: |
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| By Peter W. Kakavas, M.D., F.A.C.C., F.A.S.E. Director, Risk Factor Modification Program, Heart Care Centers of Illinois Medical Director, Clinical Research, Heart Care Research Foundation |
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Trials of lipid lowering therapy using statin drugs have revolutionized the treatment of patients with coronary artery disease. By lowering the total cholesterol, low-density lipoprotein (LDL), high-density lipoproteins (HDL) and triglycerides (TG) levels to current guidelines, the risk for cardiovascular disease can be reduced by 25 to 45%. For the first time, the 10 year mortality from heart disease has declined, primarily due to advances in coronary angioplasty during acute myocardial infarction (heart attack) and the use of cholesterol lowering medications. However, of the patients eligible for lipid lowering each year, only 18% receive therapy. Fewer still are treated to National Cholesterol Education Project Guidelines (NCEP).  Until today, the recommended LDL cholesterol level for patients with known heart and vascular disease, stroke or diabetes was less than 100 mg/dl. A landmark trial was released on March 8, 2004 at the American College of Cardiology Annual Scientific Sessions in New Orleans. The
PROVE-IT trial compared 40mg of Pravastatin (Pravachol, Bristol-Meyers-Squibb) to Atorvastatin 80mg (Lipitor, Pfizer) in patients who have suffered an acute myocardial infarction (heart attack) or unstable angina. The aim of the study was to determine if aggressive reduction in LDL cholesterol to levels below NCEP guidelines conferred any additional benefit.
The patients randomized to the Atorvastatin 80mg arm achieved LDL cholesterol levels of 62mg/dl, while the patients on Pravastatin 40mg reduced their LDL to 95mg/dl. PROVE-IT demonstrated a clear benefit of the more aggressive reduction in LDL cholesterol to 62mg/dl, with a 16% reduction in the composite endpoint of all-cause mortality (death), myocardial infarction (heart attack), unstable angina (pre-heart attack), revascularization (angioplasty or bypass surgery) and stroke. More aggressive treatment of LDL cholesterol was well tolerated, with no major side effects. Approximately 3% of patients in the Atorvastatin group had mild elevations in liver enzymes, which were not permanent. The benefit of treatment far outweighed the minor risk associated with the use of these drugs. All patients with established coronary heart disease should now have their LDL level lowered to less than or equal to 60mg/dl, because of the striking benefit of lowering LDL cholesterol demonstrated in this pivotal trial. |
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