Insull W, Kafonek S, Goldner D, Zieve F
Baylor College of Medicine, Houston, Texas, USA.
Am J Cardiol. 2001 Mar 1;87(5):554-9. doi: 10.1016/s0002-9149(00)01430-2.
The 6-week efficacy and safety of atorvastatin versus simvastatin was determined during a 54-week, open-label, multicenter, parallel-arm, treat-to-target study. In all, 1,424 patients with mixed dyslipidemia (triglyceride 200 to 600 mg/dl [2.26 to 6.77 mmol/L]) were stratified to 1 of 2 groups (diabetes or no diabetes). Patients were then randomized to receive either atorvastatin 10 mg/ day (n = 730) or simvastatin 10 mg/day (n = 694). Efficacy was determined by measuring changes from baseline in lipid parameters including low-density lipoprotein (LDL) cholesterol, total cholesterol, triglycerides, and apolipoprotein B. Compared with simvastatin, atorvastatin produced significantly greater (p < 0.0001) reductions from baseline in LDL cholesterol (37.2% vs 29.6%), total cholesterol (27.6% vs 21.5%), triglycerides (22.1% vs 16.0%), the ratio of LDL cholesterol to high-density lipoprotein (HDL) cholesterol (41.1% vs 33.7%), and apolipoprotein B (28.3% vs 21.2%), and a comparable increase from baseline in HDL cholesterol (7.4% vs 6.9%). Atorvastatin was also significantly (p < 0.0001) more effective than simvastatin at treating the overall patient population to LDL cholesterol goals (55.6% vs 38.4%). Fewer than 6% of patients in either treatment group experienced drug-attributable adverse events, which were mostly mild to moderate in nature. Diabetic patients treated with either statin had safety characteristics similar to nondiabetics, with atorvastatin exhibiting superior efficacy to simvastatin. In conclusion, atorvastatin, at a dose of 10 mg/day, is more effective than simvastatin 10 mg/day at lowering lipids and reaching LDL cholesterol goals in patients with mixed dyslipidemia. Both statins are well tolerated with safety profiles similar to other members of the statin class.
在一项为期54周的开放标签、多中心、平行组、达标治疗研究中，确定了阿托伐他汀与辛伐他汀的6周疗效和安全性。共有1424例混合性血脂异常患者（甘油三酯200至600mg/dl[2.26至6.77mmol/L]）被分层为两组（糖尿病组或非糖尿病组）中的一组。然后患者被随机分配接受阿托伐他汀10mg/天（n=730）或辛伐他汀10mg/天（n=694）。通过测量包括低密度脂蛋白（LDL）胆固醇、总胆固醇、甘油三酯和载脂蛋白B在内的血脂参数相对于基线的变化来确定疗效。与辛伐他汀相比，阿托伐他汀使LDL胆固醇相对于基线的降低幅度显著更大（p<0.0001）（37.2%对29.6%）、总胆固醇（27.6%对21.5%）、甘油三酯（22.1%对16.0%）、LDL胆固醇与高密度脂蛋白（HDL）胆固醇的比值（41.1%对33.7%）以及载脂蛋白B（28.3%对21.2%），并且使HDL胆固醇相对于基线的升高幅度相当（7.4%对6.9%）。在将总体患者人群治疗至LDL胆固醇目标方面，阿托伐他汀也显著（p<·0001）比辛伐他汀更有效（55.6%对38.4%）。两个治疗组中均不到6%的患者发生药物相关不良事件，这些事件大多为轻至中度。接受任何一种他汀类药物治疗的糖尿病患者的安全性特征与非糖尿病患者相似，阿托伐他汀的疗效优于辛伐他汀。总之，对于混合性血脂异常患者，每日剂量为10mg的阿托伐他汀在降低血脂和达到LDL胆固醇目标方面比每日10mg的辛伐他汀更有效。两种他汀类药物耐受性良好，安全性与他汀类药物其他成员相似。
