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Coronary artery disease (CAD) traditionally has been thought of as a progressive disease. Medical therapies have aimed at slowing its progression to reduce the risk of heart attack. A drug that could actually shrink plaque in the arteries was considered a dream. But clinical trials of three different approaches indicate that this dream may become a reality within our lifetime.
Raising HDL
Although low levels of “good” HDL cholesterol increase the risk of cardiac events, the value of raising HDL to above-normal levels has been hard to test clinically, because few drugs impact HDL enough to make a difference.
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That’s why recent studies of apolipoprotein A-1 (ApoA-1) Milano are important. This cholesterol-carrying protein is found only in a small number of Italian villagers who have very little atherosclerosis despite low levels of HDL. Researchers combined ApoA-1 Milano with a natural phospholipid–a major component of biological membranes–to create a substance that works like a supercharged HDL molecule to quickly escort cholesterol from the body.
In a landmark study conducted at Cleveland Clinic, five weekly doses of ApoA-1 Milano complex were given to patients with unstable angina or heart attack brought on by extensive blockages in the coronary arteries. After only five treatments, the amount of cholesterol-laden plaque in their arteries was measured by intravascular ultrasound (IVUS) and found to have decreased by 4.2 percent.
Unfortunately, this HDL-mimicking compound is not available as a drug. However, the study demonstrated the potential value of a drug that significantly raises HDL levels.
“We need to find a way to raise HDL with an oral drug,” says lead investigator investigator Steven E. Nissen, M.D., Chairman of the Department of Cardiology at Cleveland Clinic.
Manipulating cholesterol
Studies lowering LDL (”bad”) cholesterol far beyond current recommendations have proven that very low LDL can slow the progression of atherosclerosis. It appears that lowering LDL while simultaneously raising HDL may reverse the disease. The theory was first illustrated in a 2001 study that documented plaque regression with simvastatin (Zocor) combined with niacin. Niacin is one of the few drugs that raises HDL. However, unpleasant side effects such as liver dysfunction, flushing or redness of the skin, rash, and headache often prevent niacin from being taken in large enough doses to affect HDL.
Now it appears a single statin may accomplish both goals. In a 2006 clinical trial called A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound (ASTEROID), researchers gave large doses of rosuvastatin (Crestor) to patients for two years. Over this period, LDL dropped to an average of 60.8 mg/dL, and the average HDL increased by 14.7 mg/dL. Measurements taken with IVUS showed the total amount of arterial plaque was reduced nearly 9 percent.
“This was a small pilot study. We are now looking at a larger, placebo-controlled additional study that will track the effects of this drug on heart attack and cardiac deaths,” says Dr. Nissen.
Lowering blood pressure
High blood pressure is a risk factor for the development of CAD. Now it appears that lowering blood pressure may actually help reverse CAD.
In the Comparison of Amlodipine versus Enalapril to Limit Occurrences of Thrombosis (CAMELOT) trial, patients were randomized to receive one of these two blood pressure medications–amlodipine (Norvasc) or enalapril (Vasotec)–or placebo for two years. The goal was to determine the effect of these medications on heart attack and cardiac death.
But the study did not end there. More than 430 CAMELOT participants signed up to be included in a sub-study in which the amount of atherosclerosis in their coronary arteries was measured using IVUS. After 24 months of treatment, the inside measurement of the coronary arteries (lumen) was wider in patients who had taken amlodipine than in those who had taken enalapril or placebo. In addition, fewer heart attacks occurred in the amlodipine group than in the other patients. However, heart attacks had no correlation with lumen size, raising questions that need to be answered in another clinical trial.
With so many blood pressure medications on the market, Dr. Nissen thinks more than one might reverse atherosclerosis. However, he is pinning his hopes on a drug that raises HDL. “I think it’s our best bet,” he says.
WHAT YOU CAN DO
To reduce your risk of CAD:
* Eat a low-cholesterol diet.
* Use statins to lower LDL cholesterol and talk with your doctor about raising HDL.
* Keep your blood pressure at or below 120/80 mmHg.
* Don’t smoke. Smoking increases your heart attack risk even if your cholesterol and blood pressure are normal.
COPYRIGHT 2007 Belvoir Media Group, LLC
COPYRIGHT 2008 Gale, Cengage Learning