Maximum doses of Crestor (rosuvastatin) or Lipitor (atorvastatin) are similarly effective in reversing the buildup of cholesterol plaques in the coronary artery walls (atherosclerosis) after 24 months of treatment, according to Cleveland Clinic researchers. The extent of reversal of atherosclerosis observed in this trial was unprecedented and was achieved with excellent drug safety.
The SATURN trial results were presented today by lead investigator and Cleveland Clinic researcher, Stephen Nicholls MD PhD., Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research (C5) at the American Heart Association's Scientific Sessions in Orlando, Fla., and simultaneously published in The New England Journal of Medicine.
The SATURN Trial included 1,039 patients -519 in the atorvastatin group and 520 in the rosuvastatin group. The study used intravascular ultrasound (IVUS) imaging to compare the progression of coronary atherosclerosis after two years of treatment with these two drugs.
For the primary measure of efficacy, IVUS showed a 0.99 percent decrease in plaque burden with atorvastatin and a 1.22 percent decrease with rosuvastatin with no statistically significant differences between the regimens, p=0.17. A secondary endpoint, total plaque burden, did show greater reduction in plaque burden with rosuvastatin that was statistically significant, p=0.01.
The rosuvastatin regimen produced moderately greater lowering of the LDL (bad) cholesterol (62.6 mg/dL vs. atorvastatin 70.2 mg/dL) and a greater increase in HDL (good) cholesterol (50.4 mg/dL vs. atorvastatin 48.6 mg/dL). There were few adverse events observed during the study and no patients experienced serious muscle injury demonstrating that disease regression can be achieved with excellent safety.
"SATURN demonstrates that the highest doses of the most effective statins currently available is safe, well tolerated and produces marked plaque regression," said Dr. Nicholls. "The finding that these therapies produced low levels of LDL, raised HDL and removed plaque from the artery wall in a safe manner is positive news for patients with heart disease."
Dr. Nicholls served as Principal Investigator, and Steven Nissen served as Study Chairman for the Saturn Trial. Both are Cleveland Clinic physicians.