Study Compares Niacin Plus Statin Vs. Statin Alone to Delay Heart Disease

For immediate release: July 31, 2006

Contact:

Bill Seiler

bseiler@umm.edu | 410-328-8919

University of Maryland Medical Center is one of 60 sites in nationwide study

Does adding a form of long-acting niacin to one of the most common cholesterol lowering drugs do a better job of delaying the onset of heart attack, stroke, blocked arteries or death from cardiovascular disease? That is the question that University of Maryland cardiologists hope to answer as they participate in a national study. The study, called AIM-HIGH, is a multi-center, randomized, double-blind clinical trial that compares a combination of extended-release niacin plus simvastatin to simvastatin alone.

Simvastatin is one of several medications in the class of drugs known as “statins,” proven to reduce the level of LDL, the so-called “bad” cholesterol. Simvastatin, better known by its brand name Zocor, was one of the first statins to be developed. Niacin has been shown to boost the levels of HDL, the “good” cholesterol. The extended-release niacin used in the study is the newest preparation of niacin therapy. In previous combination statin/niacin studies, which used different statins, the extended release niacin boosted HDL by as much as 30 percent.

“We believe that if the study results are positive, this study will change the way we care for people with heart disease,” says Michael Miller, M.D., director of preventive cardiology at the University of Maryland Medical Center, associate professor of medicine at the University of Maryland School of Medicine and the study's principal investigator in Maryland.

“People with heart disease typically are given statins alone. Not many are placed on combination therapy, which is now considered intensive therapy,” says Dr. Miller. “We think that the HDL-raising and triglyceride-lowering and additional LDL-lowering that may occur with the combination may be better than just statins alone, but we need to prove it.”

Elevated blood fats or lipids, including cholesterol and triglyceride, can cause a fatty substance called plaque to build up in the lining of blood vessels. Over time, the plaque may harden, reduce normal blood flow to the heart and other vital organs and set the stage for a variety of cardiovascular diseases. The plaque may also rupture which triggers the formation of a blood clot and can lead to a blocked artery.

AIM-HIGH will include 3,300 patients who will be followed for 3-5 years at 60 centers in the United States and Canada. Half of the study participants will receive simvastatin alone and the other half will be given extended-release niacin and simvastatin. Men and women age 45 and older who have both vascular disease and abnormal blood fat levels will be recruited to participate.

Niacin, also known as vitamin B3, helps the body convert food to energy and is critical for normal functioning of the digestive system, the nervous system and the skin. These benefits can be realized with a low daily amount of niacin, 18 milligrams (mg) or below, depending on a person's age and sex. Niacin is available without a prescription in both immediate-release and sustained-release forms and in a prescription, extended-release form.

The cardiovascular benefits of niacin require high daily doses. In AIM-HIGH, patients will be given a starting dose of 500 mg. The daily dosage will be increased weekly over four weeks to a maximum of 2,000 mg.

Flushing, a side effect often associated with niacin, produces a burning, tingling sensation and red or “flushed” skin. Dr. Miller says the niacin used in AIM-HIGH is an extended-release, prescription medication called Niaspan. It is much less likely to cause intense flushing than the over-the-counter forms of niacin, partly because it is released over an extended period of time. Niaspan is taken only once a day compared to other forms of niacin which need to be taken two or three times daily. Even so, says Dr. Miller, “Patients will likely experience some degree of flushing.” To reduce the chance of flushing, study participants will also take aspirin, known to control flushing. Participants will also be instructed in a variety of dietary measures, which should decrease the occurrence and severity of flushing.

“People with heart disease should be on aspirin anyway. To address the flushing issue, volunteers in the study will take an aspirin about 30 minutes before they take the niacin,” says Dr. Miller. “If flushing does occur, it will be considerably less intense. Over time, we expect the flushing will not be an issue for the study participants.”

Cardiovascular disease is the leading cause of death and disability in the U.S., according to the American Heart Association. About 13.5 million people in the U.S. have a history of heart attack, chest pain or both. About 5.5 million people have had a stroke and about 8 million people suffer from peripheral arterial disease, in which blockages restrict circulation in the kidneys, stomach, arms, legs and feet.

For more information, including how to participate in the study at the University of Maryland Medical Center, please contact Michele Besche, R.N., at 410-328-6175 or Judy Ference, R.N., at 410-328-7583.

The study is sponsored by the National Heart, Lung and Blood Institute with additional funding from Kos Pharmaceuticals of Cranbury, New Jersey, maker of Niaspan. The University of Maryland Medical Center is the only site in Maryland selected to participate in AIM-HIGH.

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