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Medical News & Perspectives
April 7, 2010

FDA Approves a Statin Therapy for Some

JAMA. 2010;303(13):1242-1243. doi:10.1001/jama.2010.342

For the first time, the US Food and Drug Administration (FDA) has expanded the indications of a statin therapy that targets certain asymptomatic individuals. How this will play out in the clinical setting remains to be seen.

On February 8, the FDA announced that rosuvastatin is now indicated for the primary prevention of cardiovascular disease in men aged 50 years or older and women aged 60 years or older who meet certain criteria. These include an elevated level (2 mg/L or higher) of high-sensitivity C-reactive protein (hsCRP, a nonspecific inflammatory biomarker) and at least 1 additional cardiovascular risk factor, such as hypertension, a low level of high-density lipoprotein cholesterol, smoking, or a family history of premature heart disease. The agency had previously approved rosuvastatin for the purpose of lowering cholesterol and triglycerides in combination with diet and exercise in patients with high levels of cholesterol and/or triglycerides and slowing the progression of atherosclerosis.

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