The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia

Inclusion criteria

• the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
• Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes

Exclusion criteria

• therapy with any other investigational drug within 30 days of randomization,
• history of hypersensitivity to HMG-CoA reductase inhibitors,
• uncontrolled hypertension,
• poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),
• unstable angina or presented with new-onset myocardial infarction (within 6 months),
• creatinine >2.5 mg/dl,
• alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN,
• history of malignancy or psychosis;
• chronic liver disease,
• drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.