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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
376
Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
Seoul National University Hospital
Seoul, South Korea
% change of LDL cholesterol
The difference in percent change of serum LDL cholesterol concentration between genericAtorva and Lipitor branded group
Time frame: After 8 weeks of treatment
% 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
% change of lipoprotein and apolipoprotein ratios (ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio)
Time frame: After 8 weeks of treatment
Change of highly sensitive C-reactive protein (hsCRP)
Time frame: After 8 weeks of treatment
LDL cholesterol goal achievement rate
LDL cholesterol goal achievement rate according to NECP-ATP III guideline
Time frame: After 8 weeks of treatment
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