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Post-marketing analysis examines cholesterol-lowering drugs' side effects

DALLAS, May 23 A post-market analysis of cholesterol-lowering drugs called statins indicates that some of the most serious side effects may be higher in one of the newest drugs, rosuvastatin (Crestor). The drug is the strongest statin available because it has the greatest effect per milligram on low-density lipoprotein ("bad" cholesterol).

However, researchers emphasize that the risk involved in taking this drug is low, and that statins are still the best drugs for treating elevated cholesterol and reducing a person's risk for developing heart disease and stroke. If a patient has side effects, they generally go away when the patient stops taking the drug.

As reported in Circulation: Journal of the American Heart Association, the researchers analyzed adverse events reports (AERS) sent to the U.S. Food and Drug Administration for rosuvastatin and compared them to AERS rates during the same concurrent time period for three other statins: atorvastatin (Lipitor), simvastatin (Zocor) and pravastatin (Pravachol).

The researchers also compared AERS rates during the first year of marketing of each of the statins, which allowed a comparison of rosuvastatin to the three statins as well as to cerivastatin (Baycol). Cerivastatin, the most potent statin per milligram ever to receive FDA approval, was withdrawn from the market in 2001 after the FDA received numerous reports of severe myopathy (muscle weakness), rhabdomyolysis (muscle deterioration resulting in toxins released in the blood that can lead to renal failure), proteinuria (protein in the urine), nephropathy (a reduced ability of the kidneys to filter toxins from the blood) and kidney failure.

Researchers found that rosuvastatin was associated with a higher rate of muscle and kidney complications than the older statins, but at less than half the rate of the side effects reported for cerivastatin during its first year.

"As a class, statins are very safe medications. They have been widely use
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Contact: Carole Bullock
carole.bullock@heart.org
214-706-1279
American Heart Association
25-May-2005


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