Congress Reports

ESHonline Coverage, based on selected sessions at the:
American Heart Association 2005 Annual Scientific Sessions
November 13-16, 2005, Dallas, Texas

This activity is not sanctioned by, nor a part of, the American Heart Association.
 
 
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IDEAL: High-dose atorvastatin safe, reduces nonfatal myocardial infarction

The Incremental Decrease in Clinical Endpoints Through Aggressive Lipid Lowering (IDEAL) trial showed a 16% significant reduction in its secondary endpoint, an 11% nonsignificant reduction in its primary endpoint, and an 17% reduction in nonfatal myocardial infarction (MI) with atorvastatin 80 mg daily compared to simvastatin 20 mg. The study was presented by Dr. Terje R. Pedersen, Ulleval University Hospital, Oslo, Norway at the 2005 Scientific Sessions of the American Heart Association, held in Dallas, Texas from November 13-16. It was published simultaneously in the November 16 issue of the Journal of the American Medical Association

The primary endpoint was combined MI, coronary heart disease death, or sudden death. The secondary endpoint was the primary endpoint plus hospitalized unstable angina and bypass surgery and PCI.

Notably, the high-dose group did not have an increased risk of non-cardiac deaths compared to patients in the low-dose group. “This finding may help calm concerns that high-dose statins contribute to excess non-cardiac deaths, such as cancer, but benefits apparent in this trial were more modest than we expected,” said Pedersen.

A total of 8888 patients (average age 62, 19% women) with stable coronary heart disease were followed for an average of 5 years. Notably, 24% of patients were 70 to 80 years old. This investigator-initiated, multicenter study used the PROBE design. The dose of simvastatin could be uptitrated to 40 mg after 6 months if the total cholesterol was not reduced below 193 mg/dL.

LDL was reduced to an average of 81 mg/dL with the high-dose statin and to 10 mg/dL with the lose-dose statin.

In comments to the press, Pedersen noted that the primary endpoint may have reached statistical significance if the study continued another 3 months, and that the primary endpoint was more heavily focused on mortality than the secondary endpoint. The results indicate more intense cholesterol lowering in 1000 patients with a prior MI will prevent 68 cardiovascular events. “Maybe our findings indicate that we have gotten to the limits of what we can achieve in reducing mortality with statins, he said.

 
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