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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: generic formulation of atorvastatin (Atorva®)
* Drug: branded formulation of atorvastatin (Lipitor®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorva<br>generic formulation (Atorva®) of atorvastatin 20mg once daily | Drug: generic formulation of atorvastatin (Atorva®)<br>* Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks<br>|
| Active Comparator: Lipitor<br>branded formulation (Lipitor®) of atorvastatin 20mg once daily | Drug: branded formulation of atorvastatin (Lipitor®)<br>* Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change of LDL cholesterol | The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change of other lipid paramenters(total cholesterol, high-density lipoprotein [HDL] cholesterol, triglyceride [TG], apolipoprotein B [ApoB] and apolipoprotein A1 [ApoA1]) |  | After 8 weeks of treatment | 
| % change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio) |  | After 8 weeks of treatment | 
| Change of highly sensitive C-reactive protein (hsCRP) |  | After 8 weeks of treatment | 
| LDL cholesterol goal achievement rate | LDL cholesterol goal achievement rate according to NECP-ATP III guideline | After 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atorva, generic, atorvastatin, hypercholesterolemia