Drug Design, Development and Therapy (Aug 2017)
Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial
Abstract
Ju-Hee Lee,1,2 Sang-Hyun Kim,3,4 Dong-Ju Choi,3,5 Seung-Jea Tahk,6 Jung-Han Yoon,7 Si Wan Choi,8 Taek-Jong Hong,9 Hyo-Soo Kim3,10 1Division of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine, 2Department of Cardiology, Chungbuk National University Hospital, Cheongju, 3Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, 4Department of Cardiology, Seoul Metropolitan Government – Seoul National University Boramae Medical Center, Seoul, 5Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, 6Department of Cardiology, Ajou University Hospital, Suwon, 7Department of Cardiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, 8Department of Cardiology, Chungnam National University Hospital, Daejeon, 9Department of Cardiology, Pusan National University Hospital, Pusan, 10Department of Cardiology, Seoul National University Hospital, Seoul, South Korea Purpose: 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.Methods: This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult 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 cholesterol at 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 cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated.Results: 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 cholesterol level 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 cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal 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).Conclusion: The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia. Keywords: atorvastatin, hypercholesterolemia, low-density lipoprotein cholesterol
