More intensive cholesterol treatment an option for high risk heart patients

"The lower the better for high-risk people. That's the message on bad cholesterol – low-density lipoprotein (LDL) cholesterol – from recent clinical trials," said Scott Grundy, M.D., Ph.D., the American Heart Association's representative to the NCEP and chair of ATP III. To refine 2001 ATP III guidelines, the panel examined five major clinical trials involving cholesterol-lowering medications.

High-risk people are those who have already had a heart attack or have other risk factors, and they have more than a 20 percent estimated risk of heart attack or cardiac death within 10 years. This includes people with cardiac chest pain (angina), previous angioplasty or bypass surgery, obstructed blood vessels to the extremities or brain, or diabetes.

Previous NCEP guidelines recommended cholesterol-lowering medications for high-risk people with LDL cholesterol levels of 130 milligrams per deciliter (mg/dL) or higher.

"The aim was to reduce LDL cholesterol to less than 100 mg/dL," said Grundy, who is director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas. "For people with LDL cholesterol levels of 100-129 mg/dL, use of cholesterol-lowering drugs was a therapeutic option based on clinical judgment.

"The updated recommendations call for drug therapy in almost all high-risk patients with LDL cholesterol of 100 mg/dL or higher." The major recommendations of the updated guidelines include:

• High-risk people: The general goal of cholesterol-lowering treatment remains the same. However, in order to reduce LDL cholesterol levels to under 100 mg/dL, the panel makes an LDL goal of less than 70 mg/dL a therapeutic option for people at very high risk of heart attack or death. Patients are considered at very high risk if they already have cardiovascular disease plus diabetes, persistent cigarette smoking, poorly controlled hypertension, or multiple risk factors of the metabolic syndrome (high triglycerides, low levels of "good" HDL cholesterol, obesity), and immediately after a heart attack.
• Moderately high risk: Moderately high-risk people are those who have multiple risk factors and are estimated to have a 10 to 20 percent chance of heart attack or cardiac death within 10 years. The new guidelines reinforce the need for treatment if LDL cholesterol levels are 130 mg/dL or higher, and add an optional consideration of drug therapy if levels are between 100-129 mg/dL.
• In general, if drug therapy is used in people at high or moderately high risk, it should be aimed towards achieving a 30 to 40 percent reduction in LDL cholesterol.
• Lower or Moderate risk: Recommendations for treatment in people at lower or moderate risk are unchanged.
• Older people: Evidence from the new studies bolstered the idea that it is never too late to benefit from intervention to lower cholesterol levels.

"There is strong suggestive evidence that lower LDL cholesterol is better, but it has to be balanced against the cost and side effects of achieving very low levels, which often requires high doses of medication or combination therapy," Grundy said.

While numerical changes in the guidelines refer mainly to drug treatment, panelists stressed that addressing risk factors related to lifestyle (such as obesity and lack of physical activity) is still crucial.

"The idea that you can use cholesterol-lowering drugs without lifestyle changes is incorrect," Grundy said. "Lifestyle changes have enormous benefits beyond lowering LDL cholesterol, such as raising levels of good cholesterol, lowering triglycerides, improving diabetes, and reducing inflammation."

The recommendations will be refined further as the results of ongoing clinical trials become available.

"We're bringing people up to date, but this is not the last word on the subject," Grundy said. "In the next year and a half, more definitive information from clinical trials underway will be available."

The co-authors are James I. Cleeman, M.D.; C. Noel Bairey Merz, M.D.; H. Bryan Brewer, Jr., M.D.; Luther T. Clark, M.D.; Donald B. Hunninghake, M.D. (until Dec. 2003); Richard C. Pasternak, M.D.; Sidney C. Smith, Jr., M.D.; and Neil J. Stone, M.D.

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