Athyros Vasilios G, Papageorgiou Athanasios A, Athyrou Valasia V, Demitriadis Dimokritos S, Kontopoulos Athanasios G
Lipid Out-patient Clinic, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece.
Diabetes Care. 2002 Jul;25(7):1198-202. doi: 10.2337/diacare.25.7.1198.
This study evaluated the effect of a atorvastatin-fenofibrate combination on lipid profile, in comparison to each drug alone, in patients with type 2 diabetes and combined hyperlipidemia (CHL).
A total of 120 consecutive patients, who were free of coronary artery disease (CAD) at entry, were studied for a period of 24 weeks. These patients were randomly assigned to atorvastatin (20 mg/day, n = 40), micronized fenofibrate (200 mg/day, n = 40), or a combination of both (atorvastatin 20 mg/day plus fenofibrate 200 mg/day, n = 40). The effect of treatment on LDL cholesterol, triglycerides (TGs), HDL cholesterol, apolipoprotein A-I and B, lipoprotein(a), and plasma fibrinogen (PF) was recorded. Moreover, the percentage of patients that reached the American Diabetes Association treatment goals and the estimated CAD risk status were calculated.
No patient was withdrawn from the study because of side effects. The atorvastatin-fenofibrate combination reduced total cholesterol by 37%, LDL cholesterol by 46%, TGs by 50%, and PF by 20%, whereas it increased HDL cholesterol by 22% (P < 0.0001 for all). These changes were significantly better than those of both monotherapies. Of the patients on drug combination, 97.5% reached the LDL cholesterol treatment goal of <100 mg/dl, 100% reached the desirable TG levels of <200 mg/dl, and 60% reached the optimal HDL cholesterol levels of >45 mg/dl. These rates were significantly higher than those of both monotherapies. Combined treatment reduced the 10-year probability for myocardial infarction from 21.6 to 4.2%.
The atorvastatin-fenofibrate combination has a highly beneficial effect on all lipid parameters and PF in patients with type 2 diabetes and CHL. It improved patients' CAD risk status significantly more than each drug alone.
本研究评估了阿托伐他汀与非诺贝特联合用药对2型糖尿病合并高脂血症（CHL）患者血脂谱的影响，并与单独使用每种药物的效果进行比较。
共纳入120例入组时无冠状动脉疾病（CAD）的连续患者，研究期为24周。这些患者被随机分为阿托伐他汀组（20毫克/天，n = 40）、微粒化非诺贝特组（200毫克/天，n = 40）或两者联合组（阿托伐他汀20毫克/天加非诺贝特200毫克/天，n = 40）。记录治疗对低密度脂蛋白胆固醇、甘油三酯（TGs）、高密度脂蛋白胆固醇、载脂蛋白A-I和B、脂蛋白(a)以及血浆纤维蛋白原（PF）的影响。此外，计算达到美国糖尿病协会治疗目标的患者百分比以及估计的CAD风险状态。
没有患者因副作用退出研究。阿托伐他汀与非诺贝特联合用药使总胆固醇降低37%，低密度脂蛋白胆固醇降低46%，甘油三酯降低50%，血浆纤维蛋白原降低20%，而高密度脂蛋白胆固醇升高22%（所有P < 0.0001）。这些变化明显优于两种单一疗法。联合用药组中,97.5%的患者达到了低密度脂蛋白胆固醇治疗目标<100毫克/分升，100%的患者达到了理想的甘油三酯水平<200毫克/分升，60%的患者达到了最佳的高密度脂蛋白胆固醇水平>45毫克/分升。这些比率显著高于两种单一疗法。联合治疗使心肌梗死的10年发生概率从21.6%降至4.2%。
阿托伐他汀与非诺贝特联合用药对2型糖尿病合并CHL患者的所有血脂参数和血浆纤维蛋白原具有高度有益的作用。与单独使用每种药物相比，它能显著改善患者的CAD风险状态。
