What is considered a high dose of rosuvastatin (Crestor)?

High-Dose Rosuvastatin Definition

High-dose rosuvastatin is defined as 20 mg or 40 mg daily, which achieves ≥50% reduction in LDL cholesterol from baseline. 1, 2

Dosing Classification

High-intensity statin therapy with rosuvastatin consists of:

• Rosuvastatin 20 mg daily 1, 2
• Rosuvastatin 40 mg daily 1, 2

These doses are specifically classified as high-intensity therapy by the American Diabetes Association, American College of Cardiology/American Heart Association, and European Society of Cardiology guidelines. 1, 2

Comparison to Moderate-Intensity Dosing

Moderate-intensity rosuvastatin (5-10 mg daily) achieves only 30-49% LDL cholesterol reduction, which is insufficient for high-risk patients. 1

The distinction is clinically critical because:

• High-intensity therapy (20-40 mg) lowers LDL-C by >50% 1, 2
• Moderate-intensity therapy (5-10 mg) lowers LDL-C by only 30-49% 1

Clinical Context for High-Dose Use

High-dose rosuvastatin (20-40 mg) is specifically recommended for:

• Adults with established atherosclerotic cardiovascular disease (ASCVD) 1
• Diabetes patients aged 40-75 years at higher cardiovascular risk 1
• Post-acute coronary syndrome patients 1
• Primary prevention in patients requiring ≥50% LDL-C reduction 1, 2

FDA-Approved Dosing Range

The FDA-approved dosing range for rosuvastatin is 5-40 mg once daily, with 20-40 mg representing the high-intensity range. 3

The FDA label confirms that rosuvastatin can be administered at any time of day, with or without food, and should be swallowed whole. 3

Important Dosing Restrictions

Certain populations require dose limitations even when high-intensity therapy is indicated:

• Asian patients: Start at 5 mg daily; consider risks/benefits when exceeding 20 mg daily due to increased plasma concentrations 3
• Severe renal impairment (CrCl <30 mL/min): Start at 5 mg daily; do not exceed 10 mg daily 1, 3
• Drug interactions: Multiple medications require dose caps (cyclosporine: max 5 mg; teriflunomide/enasidenib/capmatinib: max 10 mg) 3

A critical pitfall: Clinicians often fail to uptitrate to high-dose therapy even in appropriate candidates, with studies showing only 27-38% of post-ACS patients receive high-intensity statins at discharge despite clear guideline recommendations. 1