Tuesday, February 9, 2010

Medical News: FDA Okays Statin for Primary Prevention - in Cardiovascular, Prevention from MedPage Today

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By Peggy Peck, Executive Editor, MedPage Today, Executive Editor, MedPage Today

The FDA has approved rosuvastatin (Crestor) for primary prevention of cardiovascular disease, making it the first statin to receive this indication.

The new labeling, recommended by an FDA advisory panel late last year, also marks the first time that a drug label will include an indication based on the biomarker highly-sensitive C-reactive protein, an inflammatory marker.

The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly-sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk.
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