Cleveland Clinic Foundation New Drug Fails To Reduce The Progression Of Coronary Artery Disease
CLEVELAND, Nov. 15 /PRNewswire/ -- Research led by Steven E. Nissen, M.D., Medical Director of the Cardiovascular Coordinating Center at The Cleveland Clinic, has found that a new class of drugs intended to inhibit the buildup of plaque in arteries is ineffective.
Pactimibe, the first ACAT inhibitor or plaque deterring drug to reach phase III trials, was found not only to be ineffective in reducing the progression of coronary artery disease, but in some cases to even promote it, according to the study led by Dr. Nissen. The study was presented today in the late-breaking clinical trials session at the American Heart Association's (AHA) Scientific Sessions.
Researchers had hoped this drug would mark the first new approach to treating coronary artery disease since the introduction of statins, a class of drugs that blocks the production of cholesterol in the liver.
"While the results are disappointing, we did come away with several important conclusions," Dr. Nissen said. "A number of drugs in this class are under development and while they are promising, in this study Pactimibe didn't work. It is better to know now that researchers need to reexamine the safety profile of this class of drugs and perhaps even redirect their strategies."
Coronary artery disease remains the leading cause of death in the United States. Since the introduction of statins in 1987, there have not been significant advances in drug treatments for the disease.
Researchers have recently focused on the effectiveness of acyl-coenzyme A:cholesterol O-acyltransferase (ACAT) inhibitors, a new class of drugs intended to slow or reduce the plaque buildup in the artery walls. While statins inhibit cholesterol production in the liver, they are unable to protect at least two thirds of patients from cardiovascular events.
The randomized, controlled study led by Dr. Nissen included 534 men and women with established coronary disease at 52 U.S. medical centers. To determine the effectiveness of the drug, Nissen measured the change in the plaque buildup in the artery walls using intravascular ultrasound (IVUS), an imaging device. In this procedure, an ultrasound probe is attached to a catheter and threaded into the artery. The probe is then drawn back and a series of images of the artery walls is created. Researchers can then measure the thickness of the artery walls.
"We did show the ability of IVUS to discriminate between effective and ineffective therapies," Nissen added. "This is an important conclusion as we continue to work to develop new therapies for patients with this disease."
The Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. The Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names The Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,500 full-time salaried physicians at The Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2004, patients came for treatment from every state and 100 countries. The Cleveland Clinic website address is www.clevelandclinic.org.
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