HEALTH - A cholesterol-lowering drug has for the first time been shown to shrink the kinds of blockages that cause most heart attacks, indicating that such pills may offer the first non-surgical way to start to clear clogged arteries.

A Cleveland Clinic-led study has found that intensive use of statins, the most commonly prescribed cholesterol-lowering drugs, can reverse the build-up of plaque in coronary arteries. Previous studies have shown only a slowing or halting of the progression of coronary disease, but never regression or reversal. A new study of 500 patients found that high doses of a “statin” drug began to reverse the buildup, causing plaques lining the artery walls to recede. Statins are already widely used to prevent or slow heart disease. This study of more than 500 patients found that after two years of treatment with a high dose of AstraZeneca Plc's Crestor, plaque volume was reduced by 7%to 9%.

For Steven E. Nissen of the Cleveland Clinic “This may be the beginning of a real revolution in the treatment of heart disease”. “We're not merely slowing down the inexorable progression but truly reversing the disease. It's very exciting.”

Cholesterol drug reverses heart disease and clears clogged arteries

Atherosclerosis, the most common cause of heart disease and death, involves the build-up of fat, calcium and other deposits in the coronary arteries. Removing these deposits has been a difficult challenge for drug-therapy in patients with heart disease.

“These findings suggest that maximizing the use of statins to lower cholesterol levels in patients with heart disease can substantially reduce plaque burden, an outcome previously thought unattainable,” said Steven E. Nissen, M.D., the study's lead author and interim Chairman of the Cleveland Clinic Department of Cardiovascular Medicine. “These results also imply that the goal of statin treatment in coronary disease patients should be the maximum cholesterol reduction that can be achieved safely, rather than an arbitrary target level.”

Complete results for ASTEROID (A Study to Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden) will be presented at the 55th Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta on March 13 and simultaneously published online in the Journal of the American Medical Association.

In their work, researchers found that high doses of rosuvastatin, trade name Crestor®, reduced LDL-C (bad cholesterol) by 53 percent from baseline measurements to 60.8mg/dL, the lowest level ever achieved in a statin outcomes trial. Researchers likewise noted a statistically significant increase in HDL-C (good cholesterol) of 14 percent, also groundbreaking in a statin trial. The study's combined results led to a highly significant and unprecedented reversal of coronary artery disease in all patient groups and the drug was well tolerated, Dr. Nissen said.

At its onset ASTEROID aimed to determine if very intensive statin therapy could reverse coronary atherosclerosis as determined by intravascular ultrasound (IVUS) imaging. IVUS imaging is a technique in which a small probe is placed in the coronary artery to obtain images that can be analyzed to determine the amount of plaque in arteries.

ASTEROID involved 507 patients enrolled between November 2002 and October 2003. The patients received a baseline IVUS examination and were treated with (40mg) of rosuvastatin for 24 months. After completion, 349 patients received follow-up IVUS examinations. Study endpoints included several different measurements of the volume of plaque in the coronary arteries. Further studies are needed to verify the results and determine clinical consequences of the findings.

“It is important to understand that our study measured the amount of plaque in the coronary arteries, not the rate of occurrence of adverse events, such as heart attack or stroke,” Dr. Nissen said. Therefore, these findings need to be confirmed in a larger study that assesses the effects of very intensive cholesterol lowering on clinical outcome.”

Funding for the ASTEROID trial was provided by AstraZeneca. Dr. Nissen does not accept any company honoraria, donating any money that comes to him to a charity run by the American College of Cardiology.

Dr. Howard Hutchinson, AstraZeneca's vice president of clinical development in cardiology, said the company is conducting a range of Crestor trials, but results related to clinical outcomes, such as rates of heart attack and stroke, won't be available before 2008.

Cleveland Clinic Heart & Vascular Institute is the recognized world leader in diagnosis and treatment of cardiovascular disease. Cleveland Clinic has been ranked No. 1 in the nation for cardiac care by U.S. News & World Report every year since 1995. Cleveland Clinic has been ranked among America's Ten Best Hospitals every year since 1990 by U.S. News & World Report.

The Cleveland Clinic Foundation, 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.

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