Cleveland Clinic to Lead First Head-to-Head Comparison of the Two Most Pote...( Study Designed to Determine Statin Ef...),Health

Study Designed to Determine Statin Effects on Regression of Atherosclerosis

CLEVELAND, Jan. 15 /PRNewswire/ -- Cleveland Clinic researchers will coordinate the first head-to-head comparison of the two most powerful statin medications. The trial intends to begin enrollment as early as next week. Statins are the world's most commonly prescribed drugs and widely used to treat patients with elevated cholesterol levels.

The two drugs, atorvastatin (Lipitor) and rosuvastatin (Crestor), lower LDL ("bad") cholesterol and raise HDL ("good") cholesterol. But which drug is best for patients with heart disease? This study will seek to answer this important scientific question by measuring the rate of regression of coronary disease using intravascular ultrasound (IVUS), a technique that directly measures the amount of plaque in the coronary arteries.

The SATURN study (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) will compare the ability of these two statins to stop the progression of atherosclerosis, the main cause of cardiovascular disease, over a two year treatment period.

SATURN, a multicenter, double-blind Phase IIIb trial, will use IVUS imaging to study approximately 1,300 patients at 150 hospitals in 20 countries worldwide. The trial is expected to be completed in 2011. Cleveland Clinic cardiologist Stephen J. Nicholls, M.D., PhD., will lead the trial.

Cleveland Clinic researchers have conducted two previous studies with IVUS looking at statins and the rate of atherosclerosis regression. Researchers have found a significant benefit with statins by intensively lowering LDL- cholesterol and the inflammatory marker C-reactive protein (CRP) and by raising levels of HDL cholesterol. SATURN aims to determine if differences in the ability of the different statins to lower LDL and raise HDL can promote regression (reduction in the amount of plaque in the coronary arteries).

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