Monday, February 8, 2010

Crestor (rosuvastatin) is the first statin to receive FDA approval for primary prevention

Crestor (rosuvastatin) is the first statin to receive FDA approval for primary prevention of heart disease. According to MedPageToday, the indication is for the following:
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.
The FDA has been discussing the results of a significant study called the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study. The results of the JUPITER study were published in the New England Journal of Medicine in November 2008 (and since it's now in the public domain, you can click here to read the full study). Considering that this is a paradigm shift regarding the use of statins, the FDA wanted plenty of time to go through the data before they approve a new indication.

The funny thing is that my wife and I were talking about primary prevention, normal lipid levels, hs-CRP, and primary prevention the other day. My cholesterol levels are fine, but what about my hs-CRP? Should I be on a statin? Any statin, or a specific statin?

Crestor (rosuvastatin) in marketed by AstraZeneca.

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