Lee Ju-Hee, Kim Sang-Hyun, Choi Dong-Ju, Tahk Seung-Jea, Yoon Jung-Han, Choi Si Wan, Hong Taek-Jong, Kim Hyo-Soo
Division of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine.
Department of Cardiology, Chungbuk National University Hospital, Cheongju.
Drug Des Devel Ther. 2017 Aug 2;11:2277-2285. doi: 10.2147/DDDT.S112241. eCollection 2017.
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) 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.
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, =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%, =0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, =0.804).
The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia.
本研究旨在比较阿托伐他汀通用制剂（Atorva）和参比制剂（立普妥）的疗效和耐受性，二者均为每日一次20毫克的剂量。
本研究为前瞻性开放标签随机对照研究。未根据美国国家胆固醇教育计划成人治疗组第三次报告（NCEP-ATP III）指南达到低密度脂蛋白（LDL）胆固醇目标的高胆固醇血症患者被随机分为阿托伐他汀通用制剂组或参比制剂组。主要终点是8周时血液LDL胆固醇相对于基线的变化百分比。次要终点包括总胆固醇、高密度脂蛋白（HDL）胆固醇、甘油三酯（TG）、载脂蛋白B（ApoB）和载脂蛋白A1（ApoA1）水平的变化百分比，ApoB/ApoA1和总胆固醇/HDL胆固醇比值的变化百分比，以及高敏C反应蛋白（hsCRP）水平的变化。还评估了根据NCEP-ATP III指南的LDL胆固醇目标达成率。
376例患者被随机分组，346例患者（通用制剂组176例，参比制剂组170例）完成了研究。治疗8周后，两组的LDL胆固醇水平均显著降低，且两组间的降低幅度相当（通用制剂组为-43.9%±15.3%，参比制剂组为-43.3%±17.0%，P=0.705）。两组间总胆固醇、HDL胆固醇、TG、ApoB、ApoA1、ApoB/ApoA1比值、总胆固醇/HDL胆固醇比值和hsCRP的变化百分比显示无显著差异。然而，在符合方案分析中，通用制剂组的LDL胆固醇目标达成率显著高于参比制剂组（90.6%对83.0%，P=0.039）。两组间不良事件发生率相当（12.0%对13.7%，P=0.804）。
20毫克阿托伐他汀通用制剂在治疗高胆固醇血症方面不劣于20毫克阿托伐他汀参比制剂。
