Scientists to Study Whether Combination Therapy Reduces Risk of Heart Attacks

April 11, 2007

WINSTON-SALEM, N.C. – Wake Forest University Baptist Medical Center is one of 60 sites in the country participating in a new research study to determine if two medications taken together are better for treating heart disease and stroke.

The five-year study, known as AIM-HIGH, will evaluate the effectiveness of prescription extended-release niacin and Zocor taken together – versus taking Zocor alone. The study is being sponsored by the National Heart, Lung and Blood Institute, part of the National Institutes of Health, with support from Abbott Laboratories.

The study’s goal is to determine if the combination therapy reduces rates of heart attacks, strokes, and other related events. The Triad has two sites that are enrolling participants: the Department of Internal Medicine-Endocrinology at Wake Forest Baptist and the Kulynych Center for Research, Green Valley Drive, Greensboro.

“Heart disease remains the leading cause of death and disability in the United States,” said Jamehl Demons, M.D., an internist at Wake Forest Baptist and principal investigator for the Greensboro site. “We know that there is more to heart disease prevention than lowering the ‘bad’ cholesterol. AIM-HIGH represents an opportunity for participants to further advance knowledge about heart disease and stroke.”

Zocor and niacin are both designed to improve levels of cholesterol and triglycerides. LDL, or low-density lipoprotein cholesterol, can obstruct the arteries when its concentrations are too high. This can lead to atherosclerosis or hardening of the arteries, which can result in heart attacks and strokes.

HDL, or high-density lipoprotein cholesterol, clears cholesterol out of damaged arteries and sweeps it away to the liver where it can be eliminated from the body. Research is showing that raising HDL levels is just as important for heart health as lowering LDL levels.

Triglycerides are another type of naturally occurring fat in the blood stream that, in excessive amounts, can contribute to obesity, diabetes and cardiovascular disease.

Drugs such as Zocor, which are known as statins, have been shown to be less effective at raising HDL than niacin. This is because niacin works by a different mechanism than the other drugs. Niacin has multiple effects: it raises “good” cholesterol, lowers levels of "bad" cholesterol and also lowers triglycerides.

In combination with statin drugs, niacin has been shown to substantially reduce heart disease risk in five small studies. AIM-HIGH is a larger study designed to confirm this benefit.

AIM- HIGH will enroll 3,300 men and women nationwide who are 45 years old or older and at high risk of having another heart-related event. Study participants must have a history of heart or vascular disease as well as low HDL-cholesterol and abnormal triglycerides. The AIM-HIGH study will examine outcomes such as heart attacks, death from heart disease, strokes and hospitalization for heart disease.

Participants in the study will be randomly selected to receive either Zocor alone or a combination of Zocor and niacin. There is no cost to participate in this program and participants will receive free cholesterol-lowering medicine during a three- to five-year follow-up period.

Triad residents can learn if they are eligible to participate by visiting the AIM-HIGH website (www.aimhigh-heart.com), or by contacting the study sites:

Greensboro: Kulynych Center for Research, 806 Green Valley Road, Suite 311, (336) 574-7255 or pwittmer@wfubmc.edu.

Winston-Salem: Wake Forest Baptist, Medical Center Boulevard, (336) 713-7243, or ekouba@wfubmc.edu.

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Media Contacts: Karen Richardson, krchrdsn@wfubmc.edu; Shannon Koontz, shkoontz@wfubmc.edu; at 336-716-4587.

About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,298 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.

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