Gentile S, Turco S, Guarino G, Sasso C F, Amodio M, Magliano P, Salvatore T, Corigliano G, Agrusta M, De Simone G, Gaeta I, Oliviero B, Torella R
Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy.
Diabetes Obes Metab. 2000 Dec;2(6):355-62. doi: 10.1046/j.1463-1326.2000.00106.x.
Although there is little information from primary or secondary prevention trials on cholesterol-lowering medication in diabetic patients, the reduction of elevated cholesterol is widely recommended for this group. The American Diabetes Association (ADA) recommends drug therapy in diabetic patients if low density lipoprotein (LDL)-cholesterol remains at > 130 mg/dl, or > 100 mg/dl in patients with macroangiopathy, after dietary intervention. When cholesterollowering medication is indicated, the choice of the drug must take into account the other lipid abnormalities that are often present and the need to maintain optimal glycaemic control. In the present study we compared the efficacy and safety of the novel HMG-CoA reductase inhibitor atorvastatin at the dose of 10 mg/day with simvastatin , lovastatin and pravastatin at doses of 10, 20 and 20 mg/day, respectively, and placebo, in type 2 diabetic patients with moderate elevation of LDL-cholesterol with or without elevation of triglycerides. All the quoted agents are enzyme inhibitors effective in lowering LDL-cholesterol in humans. The efficacy endpoints were the mean per cent changes in plasma LDL-cholesterol (primary), total cholesterol, triglycerides, and high-density lipoprotein (HDL)-cholesterol concentrations from baseline to the end of treatment (24 weeks). Atorvastatin at a dose of 10 mg/day produced: (1) a significant reduction in LDL-cholesterol (-37%) in comparison with equivalent doses of simvastatin (-26%), pravastatin (-23%), lovastatin (-21%), and placebo (-1%); (2) HDL-cholesterol increases (7.4%) comparable to or greater than those obtained with simvastatin (7.1%), pravastatin (3.2%), lovastatin (7.21%), and placebo (-0.5%); (3) a significantly greater reduction in total cholesterol (- 29%) than that obtained with simvastatin (-21%), pravastain (-16%), lovastatin (-18%), and placebo (1%); and (4) a significantly greater reduction in triglycerides than that obtained with all the other drugs and placebo. In all treatment groups no significant variation in fibrinogen concentration was observed. All reductase inhibitors studied had similar levels of tolerance. There were no incidents of persistent elevations of serum aminotransferases or myositis.
虽然关于糖尿病患者使用降胆固醇药物进行一级或二级预防试验的信息很少，但广泛建议该群体降低升高的胆固醇水平。美国糖尿病协会（ADA）建议，在饮食干预后，如果糖尿病患者的低密度脂蛋白（LDL）胆固醇仍高于130mg/dl，或患有大血管病变的患者高于100mg/dl，则应进行药物治疗。当需要使用降胆固醇药物时，药物的选择必须考虑到常伴随出现的其他血脂异常情况以及维持最佳血糖控制的必要性。在本研究中，我们比较了新型HMG-CoA还原酶抑制剂阿托伐他汀10mg/天的剂量与辛伐他汀、洛伐他汀和普伐他汀分别为10、20和20mg/天的剂量以及安慰剂，在伴有或不伴有甘油三酯升高的中度LDL胆固醇升高的2型糖尿病患者中的疗效和安全性。所有引用的药物都是在人体内有效降低LDL胆固醇的酶抑制剂。疗效终点是从基线到治疗结束（24周）时血浆LDL胆固醇（主要指标）、总胆固醇、甘油三酯和高密度脂蛋白（HDL）胆固醇浓度的平均变化百分比。10mg/天剂量的阿托伐他汀产生了：（1）与等效剂量的辛伐他汀（-26%）、普伐他汀（-23%）、洛伐他汀（-21%）和安慰剂（-1%）相比，LDL胆固醇显著降低（-37%）；（2）HDL胆固醇升高（7.4%），与辛伐他汀（7.1%）、普伐他汀（3.2%）、洛伐他汀（7.21%）和安慰剂（-0.5%）相当或更高；（3）总胆固醇显著降低（-29%），大于辛伐他汀（-21%）、普伐他汀（-16%）、洛伐他汀（-18%）和安慰剂（1%）；（4）甘油三酯降低幅度显著大于所有其他药物和安慰剂。在所有治疗组中，未观察到纤维蛋白原浓度有显著变化。所有研究的还原酶抑制剂的耐受性水平相似。没有血清转氨酶持续升高或发生肌炎的情况。
