DG DISPATCH - AHA: High-dose Fluvastatin Fails To Prevent Acute Myocardial Infarction Events
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DG DISPATCH - AHA: High-dose Fluvastatin Fails To Prevent Acute Myocardial Infarction Events

By Ed Susman
Special to DG News

NEW ORLEANS, LA -- November 17, 2000 -- The FLORIDA (Fluvastatin on Risk Diminishing after Acute Myocardial Infarction) study failed to show that high-dose fluvastatin administered to patients in the hospital affected outcome a year later.

Anho Liem, MD, a cardiologist in the department of cardiology, University Hospital Groningen, the Netherlands, said the study was an attempt to determine if statin therapy could affect endothelial function, which plays a central role in atherosclerosis.

"We all know that stains may restore endothelial function and it may well be that normalization of endothelial function precedes reduction of events. So an early start of statin treatment may prove to be beneficial," Dr. Liem explained at the 73rd annual scientific sessions of the American Heart Association.

The FLORIDA study included 550 patients-83 percent men-with acute myocardial infarction. Dr. Liem said the goal of FLORIDA was to study the mechanisms of ischemia and shouldn’t be considered a true clinical end point study.

He said the results of FLORIDA could not be compared with MIRACL-use of atorvastatin in acute coronary syndromes-because the patient population was considerably different as was the seriousness of the coronary events being studied. In addition, statin treatment was begun eight days after admission to the hospital in Florida, compared with two to four days in MIRACL.

In the FLORIDA study, Dr. Ad J. van Boven an interventional cardiologist at Groningen said patients were placed on a Holter monitor to measure ischemia. Patients received 80 mg of fluvastatin a day, but there was no evidence of an effect on events or ischemia as compared to placebo.

About 12 percent of patients had ischemia at baseline, van Boven said. After six weeks, there was a drop in ischemia to about eight percent in patients on fluvastatin; 6 percent in patients on placebo. "Surprisingly," van Boven said, "after one year in the fluvastatin group a further drop was noted with six percent of patients having ischemia, but in the placebo group there was a rise to 10 percent of patients having ischemia." He said the differences were not statistically significant.

The researchers said ischemia at baseline tended to reflect the impact of using the cholesterol-lowering drug. At one year, 61 percent of patients with ischemia at baseline who received placebo still had ischemia, but 50 percent of fluvastatin patients still had ischemia.

Related Links: Fluvastatin.

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