News Release

People Who Are Diabetic And Glucose Intolerant Can Benefit From "Statin" Drug Therapy, Even If Cholesterol Levels Are Normal

Peer-Reviewed Publication

American Heart Association

DALLAS, Dec. 8 -- A cholesterol-lowering drug may help reduce the risk of another heart attack and the need for artery-opening procedures in people with diabetes and heart disease who have average blood levels of cholesterol, according to a study in today's issue of Circulation: Journal of the American Heart Association.

The study involved a subgroup of 586 diabetic individuals in the Cholesterol and Recurrent Events (CARE) trial, a five-year study that compared therapy using the drug pravastatin to placebo in men and women who had a previous heart attack and average blood levels of cholesterol.

"Although diabetes is a major risk factor for heart disease, little information is available on the effects of cholesterol-lowering therapies in individuals with diabetes," says co-author Frank M. Sacks, M.D., associate professor of medicine at Harvard Medical School and Brigham and Women's Hospital, Boston. Because the CARE trial population -- a total of 4,159 patients from 80 clinical centers in the United States and Canada -- included a large number of individuals, scientists had enough data to determine whether pravastatin therapy reduced the risk of recurrent heart attack or the need for treatment to unblock the arteries in people with diabetes.

Pravastatin is one of the statin class of cholesterol-lowering drugs called HMG CoA inhibitors.

Sacks reports that, compared with those in the placebo group, diabetic patients who received pravastatin had a 25 percent reduction in relative risk of having another heart attack. The relative risk of needing coronary artery bypass or angioplasty to unblock blood vessels was reduced by 32 percent in the statin-treated group.

The researchers also analyzed data from a subgroup of 342 people without diabetes who met the American Diabetes Association's definition of being glucose intolerant (fasting blood glucose levels between 110 to 125 mg/dL). "This subgroup had a higher rate of coronary events, such as recurrent heart attacks or the need for revascularization surgery, than patients with normal fasting glucose, although not as high as those with diabetes," Sacks says. "Those who were glucose intolerant and received pravastatin had a lower rate of coronary events than those receiving placebo, although because of the small sample size, the difference was not statistically significant."

Glucose intolerance is an indication that the body is not able to use glucose normally, which sometimes leads to elevations of glucose in the blood. People who are glucose intolerant could become diabetic if their condition is not treated.

People with or without diabetes who have abnormal fasting glucose levels are at high risk of recurrent coronary events that may be substantially reduced by pravastatin treatment, the authors conclude.

Because people with diabetes are at substantially higher than normal risk for heart disease, cholesterol-lowering therapy should be much more cost effective in this population than in those without the disease, Sacks says.

Additional studies may settle the question whether cholesterol-lowering therapy can also reduce the risk of initial heart attacks or hospitalization in individuals with diabetes who have not suffered a heart attack, Sacks says. The take-home message, he says, is that physicians should aggressively manage heart disease risk factors in heart attack patients with diabetes or glucose intolerance. They should also consider recommending cholesterol-lowering therapy for these patients, he adds.

The study's other co-authors are Ronald B. Goldberg, M.D.; Margot Mellies, M.D.; Lemuel A. Moyé, M.D., Ph.D.; Barbara Howard, Ph.D.; William James Howard, M.D.; Barry R. Davis, M.D., Ph.D.; Thomas G. Cole, Ph.D.; Marc A. Pfeffer, M.D., Ph.D.; and Eugene Braunwald, M.D.

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CONTACT:
For journal copies only,
please call: 214-706-1173
For other information, call:
Carole Bullock: 214-706-1279 or
Brian Henry: 214-706-1135

Media advisory: Dr. Sacks can be reached by phone at: 617-432-1420; or by fax at: 617-432-3101. (Please do not publish these numbers.)



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