FDA Approves Crestor (rosuvastatin) for Cardiovascular Risk Reduction in Adults
The FDA has approved Crestor (rosuvastatin) for a new indication: reducing the risk of major adverse cardiovascular events (CV death, nonfatal myocardial infarction, nonfatal stroke, or arterial revascularization) in adults without established coronary heart disease who are at increased risk based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. This expands the statin's use beyond lipid lowering to primary prevention in a select high-risk population. Crestor, an HMG-CoA reductase inhibitor, was originally approved in 2003 for lipid disorders. The approval is supported by the JUPITER trial, which demonstrated CV event reduction in this population. Clinicians should consider this option for patients meeting the specific risk criteria.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Crestor is an HMG-CoA reductase inhibitor (statin) that inhibits the conversion of HMG-CoA to mevalonate, a rate-limiting step in cholesterol biosynthesis.
Crestor is indicated to reduce the risk of major adverse cardiovascular events (CV death, nonfatal MI, nonfatal stroke, or arterial revascularization) in adults without established coronary heart disease who are at increased risk based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. It is also indicated as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia; reduce LDL-C and slow atherosclerosis progression in adults; reduce LDL-C in adults and pediatric patients ≥8 years with HeFH; as adjunct to other LDL-C-lowering therapies or alone to reduce LDL-C in adults and pediatric patients ≥7 years with HoFH; and as adjunct to diet for adults with primary dysbetalipoproteinemia or hypertriglyceridemia.
Take orally with or without food at any time of day. Assess LDL-C as early as 4 weeks after initiation and adjust dose if needed. Adults: 5-40 mg once daily. Pediatric HeFH: 5-10 mg once daily for ages 8 to <10 years; 5-20 mg once daily for ages ≥10 years. Pediatric HoFH: 20 mg once daily for ages ≥7 years. Asian patients: initiate at 5 mg once daily; consider risks/benefits if not controlled at doses up to 20 mg. Severe renal impairment (not on hemodialysis): initiate at 5 mg once daily; do not exceed 10 mg. Dosage modifications due to drug interactions: see label Table 1.
Trial data not available in label.
Not reported in label.
Crestor provides a statin option for primary prevention of CV events in adults without established CHD but with elevated hsCRP and additional risk factors. It also serves as a lipid-lowering agent for various dyslipidemias, including familial forms, with dosing adjustments for Asian patients and those with renal impairment.
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