Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial

This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva®) and the reference formulation (Lipitor®) of atorvastatin, both at a dosage of 20 mg once daily.This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterolgoals according to the National Cholesterol Education ProgramAdult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterolat 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B(ApoB), and apolipoprotein A1(ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterolratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterolgoal achievement rate according to the NCEP-ATP III guideline was also evaluated.Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterollevel was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterolratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterolgoal achievement rate was significantly higher in the generic group compared to the reference group(90.6% vs 83.0%, P=0.039) in per- protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804).The generic formulation of atorvastatin20 mg was not inferior to the reference formulation of atorvastatin20 mg in the management of hypercholesterolemia.