FDA approved Crestor (rosuvastatin) for Cardiovascular Risk Reduction in AdultsFDA approved Crestor to prevent heart attacks and strokes in certain adults.

FDA From the archive Source published August 12, 2003 Summary added May 5, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Crestor for primary CV risk reduction in adults without CHD who have hsCRP ≥2 mg/L and at least one additional risk factor.

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)

Mechanism of Action

Crestor is an HMG-CoA reductase inhibitor (statin) that inhibits the conversion of HMG-CoA to mevalonate, a rate-limiting step in cholesterol biosynthesis.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The FDA has approved Crestor (rosuvastatin) for a new use: preventing major heart and blood vessel problems in certain adults who have not yet had a heart attack or stroke. Crestor is a statin, a type of medicine that lowers cholesterol. It was first approved in 2003 for people with high cholesterol. Now, it can also be used for primary prevention in a select group of patients.

Who is this for? Adults without established heart disease who are at increased risk based on age, a high level of C-reactive protein (a marker of inflammation) of 2 mg/L or more, and at least one other heart risk factor such as high blood pressure or smoking. The approval is based on the JUPITER study, which showed that Crestor reduced the risk of heart attack, stroke, and other events in this population.

What does this approval mean? It gives doctors another tool to help prevent first heart attacks or strokes in people with inflammation and other risks. However, it does not mean that everyone with high inflammation should take Crestor. The decision should be made carefully with a healthcare provider.

If you think you might be at risk, talk to your doctor. They can check your inflammation levels and other risk factors to see if Crestor is right for you. This approval is not a recommendation for everyone; it is for a specific group of patients who meet the exact criteria.

What this means for you:

Crestor can now prevent heart attacks in certain at-risk adults without heart disease; talk to your doctor to see if you qualify.

Study Details

Study typeFda approval

PublishedAug 2003

View Original Abstract ↓

1 INDICATIONS AND USAGE CRESTOR is indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: ∘ Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. ∘ Reduce LDL-C and slow the progression of atherosclerosis in adults. ∘ Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: ∘ Primary dysbetalipoproteinemia. ∘ Hypertriglyceridemia. CRESTOR is an HMG Co‑A reductase inhibitor (statin) indicated: ( 1 ) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: ∘ reduce LDL-C in adults with primary hyperlipidemia. ∘ reduce LDL-C and slow the progression of atherosclerosis in adults. ∘ reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: ∘ Primary dysbetalipoproteinemia. ∘ Hypertriglyceridemia.

FDA approved Crestor (rosuvastatin) for Cardiovascular Risk Reduction in AdultsFDA approved Crestor to prevent heart attacks and strokes in certain adults.

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