On February 9, 2010, the US Food and Drug Administration (FDA) extended its approval of rosuvastatin to include the indication for reducing the risk of stroke, myocardial infarction (MI), and revascularization procedures in individuals who have normal low-density lipoprotein cholesterol (LDL-C) levels and no clinically evident coronary heart disease but have an increased risk based on age, high-sensitivity C-reactive protein (hsCRP) levels, and the presence of at least 1 additional cardiovascular disease risk factor.1 The decision by the FDA was based on results from the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study, which demonstrated a 44% risk reduction in the primary end point in 17 802 primary prevention patients randomly allocated to treatment with rosuvastatin, 20 mg, compared with placebo.2
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Treatment effect by high-sensitivity C-reactive protein (hsCRP) categories. Data are stratified according to 3 different hsCRP cut points: 4.2 mg/L (median), 4.0 mg/L, and 3.0 mg/L (American Heart Association/Centers for Disease Control and Prevention cut point for high risk) (to convert hsCRP to nanomoles per liter, multiply by 9.524). Compared with placebo, treatment with rosuvastatin significantly reduced cardiovascular events in every hsCRP category. Pint indicates interaction P value.
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