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

AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.

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:

1. subjects with prior history of clinical ASCVD
2. subjects with primary elevation of LDL cholesterol ≥190 mg/dL
3. subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
4. 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:

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