The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg

• % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1]) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
• % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
• Change of highly sensitive C-reactive protein (hsCRP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
• LDL cholesterol goal achievement rate [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
  LDL cholesterol goal achievement rate according to NECP-ATP III guideline

The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher in Atorva group. Both treatments were well tolerated.

• Drug: generic formulation of atorvastatin (Atorva®)
  Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
• Drug: branded formulation of atorvastatin (Lipitor®)
  Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks

• Experimental: Atorva
  generic formulation (Atorva®) of atorvastatin 20mg once daily
  Intervention: Drug: generic formulation of atorvastatin (Atorva®)
• Active Comparator: Lipitor
  branded formulation (Lipitor®) of atorvastatin 20mg once daily
  Intervention: Drug: branded formulation of atorvastatin (Lipitor®)

Inclusion Criteria:

• Eligible patients were men or women aged between 20 and 79 years who have not achieved LDL cholesterol goals using the National Cholesterol Education Program Adult Treatment Panel Ⅲ (NCEP-ATP Ⅲ) guideline, with the treatment goal of LDL cholesterol being <100 mg/dL for patients with coronary artery disease (CAD) or CAD-equivalent disease, <130 mg/dL for patients with multiple risk factors (10-year coronary heart disease [CHD] risk ≤20%), and <160 mg/dL for patients with 0 to 1 risk factors.

Exclusion Criteria:

• Exclusion criteria were as follows: currently taking any kind of anti-hyperlipidemic drug (within 4 weeks before enrollment); hypersensitivity or intolerance to atorvastatin or other HMG-CoA reductase inhibitor; newly diagnosed (within 3 months before enrollment) or uncontrolled diabetes (hemoglobin A1C >9%); uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels ≥2 times the upper limit of normal [ULN]); an unexplained serum creatinine kinase (CK) elevation >2 times the ULN, chronic renal failure (a serum creatinine concentration >2.5 mg/dL); in patients who experienced operation at the time of screening, the patients must have a result of lipid profiles within 24 hours or after 6 weeks; a history of malignancy or cervical dysplasia; pregnant or breastfeeding women; women of childbearing potential had to be using adequate methods of contraception; a history of drug abuse or alcoholism; participation in other studies 4 weeks before enrollment. Patients could also be excluded if their participation was considered inappropriate by the study physician.