Milionis Haralampos J, Rizos Evangelos, Kostapanos Michael, Filippatos Theodosios D, Gazi Irene F, Ganotakis Emmanuel S, Goudevenos John, Mikhailidis Dimitri P, Elisaf Moses S
Department of Internal Medicine School of Medicine, University of Ioannina, Greece.
Curr Med Res Opin. 2006 Jun;22(6):1123-31. doi: 10.1185/030079906X112462.
In a 24-week, open-label, randomized, parallel-group study, we compared the efficacy and metabolic effects, beyond low density lipoprotein cholesterol (LDL-C)-lowering, of atorvastatin (ATV) and rosuvastatin (RSV) in cardiovascular disease-free subjects with primary hyperlipidaemia, treated to an LDL-C target (130 mg/dL).
After a 6-week dietary lead-in period, patients were randomized to RSV 10 mg/day (n = 60) or ATV 20 mg/day (n = 60). After 6 weeks on treatment the dose of the statin was increased (to RSV 20 mg/day or ATV 40 mg/day) if the treatment goal was not achieved. A control group of healthy volunteers (n = 60) was also included for the validation of baseline serum and urinary laboratory parameters. The primary outcome was the percentage of patients reaching the LDL-C goal; secondary outcomes were changes in lipid and non-lipid metabolic parameters.
A total of 45 patients (75.0%) in the RSV-treated group and 43 (71.7%) in the ATV-treated group achieved the treatment target at the initial dose. Both regimens were generally well tolerated and there were no withdrawals due to treatment-related serious adverse events. Similar significant reductions in total cholesterol, LDL-C, apolipoprotein (apo) B, triglycerides, apoB/apoA1 ratio, fibrinogen and high-sensitivity C-reactive protein levels were seen. RSV had a significant high density lipoprotein cholesterol (HDL-C)-raising effect and showed a trend towards increasing apoA1 levels. Glycaemic control and renal function parameters were not influenced by statin therapy. ATV, but not RSV, showed a significant hypouricaemic effect.
RSV and ATV were equally efficacious in achieving LDL-C treatment goals in patients with primary hyperlipidaemia at the initial dose and following dose titration. RSV seems to have a significantly higher HDL-C-raising effect, while ATV lowers serum uric acid levels.
在一项为期24周的开放标签、随机、平行组研究中，我们比较了阿托伐他汀（ATV）和瑞舒伐他汀（RSV）在无心血管疾病的原发性高脂血症患者中，除降低低密度脂蛋白胆固醇（LDL-C）之外的疗效和代谢作用，这些患者被治疗至LDL-C目标值（130mg/dL）。
经过6周的饮食导入期后，患者被随机分为瑞舒伐他汀10mg/天组（n = 60）或阿托伐他汀20mg/天组（n = 60）。治疗6周后，如果未达到治疗目标，则增加他汀类药物的剂量（至瑞舒伐他汀20mg/天或阿托伐他汀40mg/天）。还纳入了一组健康志愿者作为对照组（n = 60），用于验证基线血清和尿液实验室参数。主要结局是达到LDL-C目标的患者百分比；次要结局是脂质和非脂质代谢参数的变化。
瑞舒伐他汀治疗组共有45例患者（75.0%），阿托伐他汀治疗组有43例患者（71.7%）在初始剂量时达到治疗目标。两种治疗方案总体耐受性良好，且没有因治疗相关严重不良事件而停药的情况。观察到总胆固醇、LDL-C、载脂蛋白（apo）B、甘油三酯、apoB/apoA1比值、纤维蛋白原和高敏C反应蛋白水平均有类似的显著降低。瑞舒伐他汀具有显著升高高密度脂蛋白胆固醇（HDL-C）的作用，并显示出apoA1水平升高的趋势。血糖控制和肾功能参数不受他汀类药物治疗的影响。阿托伐他汀显示出显著的降尿酸作用，而瑞舒伐他汀则没有。
在原发性高脂血症患者中，瑞舒伐他汀和阿托伐他汀在初始剂量及剂量滴定后实现LDL-C治疗目标方面同样有效。瑞舒伐他汀似乎具有显著更高的升高HDL-C的作用，而阿托伐他汀则可降低血清尿酸水平。
