High doses of statins reduce plaque, reverse expected progression of coronary artery disease

American Heart Association Late-Breaking Clinical Trial Report - Abstract: 18600 - EMBARGOED UNTIL 8AM ET

November 15, 2011 Categories: Heart News, Scientific Conferences & Meetings
Study Highlights:
  • High doses of either rosuvastatin or atorvastatin reduced the amount of plaque in clogged arteries to the heart.
  • High doses of these statins were safe and reversed the progression of coronary artery disease.
ORLANDO, FLA., Nov. 15, 2011 ― High doses of two statins ― rosuvastatin (40 mg) and atorvastatin (80 mg) ― reversed the progression of coronary artery disease by reducing some of the plaque in clogged arteries supplying blood to the heart, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2011.
The study is simultaneously published in the New England Journal of Medicine.
 
Involving 1,385 patients from 215 centers, SATURN (Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin) is the largest study using intracoronary ultrasound to measure changes in the amount of plaque in coronary arteries.
 
During 24 months, SATURN researchers compared the impact of two medications effective in lowering “bad” LDL cholesterol, but differing in their effect on “good” HDL cholesterol.
In previous studies, high doses of rosuvastatin raised HDL cholesterol 7 percent to 15 percent while atorvastatin showed little effect on good cholesterol.
In the study’s major finding, the amount of plaque in the assessed part of the coronary artery (called the atheroma volume) fell 0.99 percent with atorvastatin and 1.22 percent with rosuvastatin, a difference that was not statistically significant.
 
“Regression of plaque has been the holy grail of heart disease treatment, and in this trial more than two-thirds of the patients had regression,” said Stephen J. Nicholls, M.D., Ph.D., lead researcher and cardiovascular director of the Cleveland Clinic Coordinating Center for Clinical Research in Ohio. “It’s a very positive outcome for patients and shows the benefits of high doses of statins.”
 
 Among the study’s other findings:
  • In another method of analyzing the ultrasound results (total atheroma volume), atorvastatin reduced plaque 4.4 cubic mm and rosuvastatin 6.4 cubic mm.
  • Atorvastatin reduced total plaque in 64.7 percent of patients and rosuvastatin in 71.3 percent of patients.
  • Average bad LDL cholesterol levels were 70 mg/dl in patients on atorvastatin and 62.6 mg/dl in patients on rosuvastatin;
  • Average good HDL cholesterol levels were 48.6 mg/dl with atorvastatin and 50.4 mg/dl with rosuvastatin.
“The differences between the two drugs were modest and the difference in HDL levels was less than we were anticipating based on previous studies,” Nicholls said.
Study participants had undergone coronary angiography, usually because of chest pain and an abnormal stress test.
 
In previous studies on similar patients taking lower doses of medication, over two years, 15 percent to 20 percent experienced a heart attack or stroke or underwent an angioplasty procedure to open a clogged artery. In SATURN, these events occurred at less than half that rate.
 
“Doctors have been reluctant to use high doses of statins, but in this study the drugs were safe, well tolerated and had a profound impact on lipid levels, the amount of plaque in vessel walls and the number of cardiovascular events,” Nicholls said.
 
Co-authors are Christie M. Ballantyne, M.D.; Philip J. Barter, M.B.B.S., Ph.D.; M. John Chapman, Ph.D.; Raimund M. Erbel, M.D., Ph.D.; Peter Libby, M.D.; Joel S. Raichlen, M.D.; Kiyoko Uno, M.D.; Marilyn Borgman, R.N., B.S.N.; Kathy Wolski, M.P.H.; and Steven E. Nissen, M.D.
AstraZeneca funded the study.
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