Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.

Inclusion criteria

• subjects with prior history of clinical ASCVD
• subjects with primary elevation of LDL cholesterol ≥190 mg/dL
• subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
• subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%.

Exclusion criteria

• history of significant statin-induced rhabdomyolysis or myopathy
• history of a significant hypersensitivity reaction to rosuvastatin
• uncontrolled diabetes mellitus (HbA1c >9%)
• uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
• current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
• chronic kidney disease (serum creatinine clearance <30 ml/min)
• creatine kinase levels >3 times the upper limit of normal
• use of prohibited concomitant therapies
• history of malignancy within the last 5 years
• women who were pregnant, breast-feeding or of childbearing potential without contraception
• subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.