Karalis Dean G, Ross Andrew M, Vacari Ralph M, Zarren Harvey, Scott Robert
Cardiology Consultants of Philadelphia, Philadelphia, Pennsylvania, USA.
Am J Cardiol. 2002 Mar 15;89(6):667-71. doi: 10.1016/s0002-9149(01)02337-2.
The efficacy and safety of atorvastatin 10 mg versus simvastatin 20 mg and atorvastatin 80 mg versus simvastatin 80 mg was determined in a 6-week, prospective, randomized, open-label, blinded end-point trial of dyslipidemic patients with and without coronary heart disease. A total of 1,732 patients with hypercholesterolemia and triglycerides < or =600 mg/dl (6.8 mmol/L) were randomized to receive either atorvastatin 10 mg (n = 650), simvastatin 20 mg (n = 650), atorvastatin 80 mg (n = 216), or simvastatin 80 mg (n = 216). The primary efficacy parameter was the change in low-density lipoprotein (LDL) cholesterol from baseline to week 6. Secondary efficacy parameters included the percent change from baseline to week 6 in total cholesterol, triglyceride, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein cholesterol, apolipoprotein B, and the percent of patients achieving their National Cholesterol Education Program (NCEP) LDL cholesterol goal at study end. Atorvastatin had significantly greater reductions from baseline in LDL cholesterol than simvastatin in both comparator groups: atorvastatin 10 mg (37.1%) versus simvastatin 20 mg (35.4%) (p = 0.0097), and atorvastatin 80 mg (53.4%) versus simvastatin 80 mg (46.7%) (p <0.0001). Atorvastatin 10 and 80 mg also provided significantly greater reductions in total cholesterol, triglycerides, very-low-density lipoprotein cholesterol, and apolipoprotein B than simvastatin 20 and 80 mg, respectively (all p <0.05). All treatment groups had a significantly decreased LDL cholesterol/HDL cholesterol ratio from baseline (all p <0.0001). In both comparator groups a higher proportion of atorvastatin-treated patients reached their NCEP LDL cholesterol goal compared with simvastatin. All 4 study treatments were well tolerated.
在一项为期6周的前瞻性、随机、开放标签、终点盲法试验中，对伴有或不伴有冠心病的血脂异常患者，测定了10毫克阿托伐他汀与20毫克辛伐他汀以及80毫克阿托伐他汀与80毫克辛伐他汀的疗效和安全性。共有1732例高胆固醇血症且甘油三酯≤600毫克/分升（6.8毫摩尔/升）的患者被随机分组，分别接受10毫克阿托伐他汀（n = 650）、20毫克辛伐他汀（n = 650）、80毫克阿托伐他汀（n = 216）或80毫克辛伐他汀（n = 216）治疗。主要疗效参数是低密度脂蛋白（LDL）胆固醇从基线到第6周的变化。次要疗效参数包括从基线到第6周总胆固醇、甘油三酯、高密度脂蛋白（HDL）胆固醇、极低密度脂蛋白胆固醇、载脂蛋白B的变化百分比，以及在研究结束时达到美国国家胆固醇教育计划（NCEP）LDL胆固醇目标的患者百分比。在两个比较组中，阿托伐他汀使LDL胆固醇从基线的降低幅度均显著大于辛伐他汀：10毫克阿托伐他汀（降低37.1%）对比20毫克辛伐他汀（降低35.4%）（p = 0.0097），以及80毫克阿托伐他汀（降低53.4%）对比80毫克辛伐他汀（降低46.7%）（p <0.0001）。10毫克和80毫克阿托伐他汀分别使总胆固醇、甘油三酯、极低密度脂蛋白胆固醇和载脂蛋白B的降低幅度也显著大于20毫克和80毫克辛伐他汀（所有p <0.05）。所有治疗组的LDL胆固醇/HDL胆固醇比值均较基线显著降低（所有p <0.0001）。在两个比较组中，与辛伐他汀相比，接受阿托伐他汀治疗的患者中达到NCEP LDL胆固醇目标的比例更高。所有4种研究治疗的耐受性均良好。
