Stohler R, Keller U, Riesen W F
Department of Medicine, University Hospital Basel, Switzerland.
Eur J Clin Pharmacol. 1989;37(2):199-203. doi: 10.1007/BF00558233.
Sixteen patients with primary hypercholesterolaemia received double-blind either fenofibrate (n = 8; 200 mg bid) or the HMG-CoA reductase inhibitor simvastatin (n = 8; 20 mg q.p.m. [corrected] or 40 mg q.p.m. [corrected] if LDL-cholesterol did not fall below 3.6 mmol.l-1 after 4 weeks of treatment). Simvastatin reduced total cholesterol from 9.7 to 7.0 mmol.l-1 after 10 weeks (-28%), and fenofibrate reduced it from 9.2 to 7.7 mmol.l-1 (-15%). The decrease was less during fenofibrate than during simvastatin treatment (time x drug: p = 0.02). Serum LDL-cholesterol fell from 8.3 to 5.3 mmol.l-1 (-36%) during simvastatin and from 7.2 to 6.0 mmol.l-1 (-16%) during fenofibrate administration. Again, the effect of simvastatin was more pronounced than that of fenofibrate (time x drug: p = 0.03). HDL-cholesterol increased significantly from 1.1 to 1.2 mmol.l-1 (+13%) during fenofibrate administration and it did not change significantly during simvastatin. Serum triglycerides fell from 1.3 to 1.1 mmol.l-1 (-16%) during simvastatin, and even more significantly from 2.2 to 1.1 mmol.l-1 (-51%) during fenofibrate (time x drug: p = 0.002). Apolipoprotein B fell on simvastatin from 1.9 to 1.4 g.l-1 (-24%) and from 1.8 to 1.4 g.l-1 (-22%) during fenofibrate. Both drugs were well tolerated and had no significant adverse effects. Simvastatin lowered total and LDL-cholesterol concentrations more than fenofibrate, while the latter had more effect on triglycerides, suggesting specific indications for the two drugs in the treatment of hyperlipoproteinaemias.
16例原发性高胆固醇血症患者接受双盲治疗,其中8例服用非诺贝特(200毫克,每日两次),另8例服用HMG-CoA还原酶抑制剂辛伐他汀(20毫克,每晚一次;若治疗4周后低密度脂蛋白胆固醇未降至3.6毫摩尔/升以下,则为40毫克,每晚一次)。辛伐他汀治疗10周后,总胆固醇从9.7毫摩尔/升降至7.0毫摩尔/升(降低28%),非诺贝特则将其从9.2毫摩尔/升降至7.7毫摩尔/升(降低15%)。非诺贝特治疗期间的降低幅度小于辛伐他汀治疗期间(时间×药物:p = 0.02)。辛伐他汀治疗期间,血清低密度脂蛋白胆固醇从8.3毫摩尔/升降至5.3毫摩尔/升(降低36%),非诺贝特治疗期间从7.2毫摩尔/升降至6.0毫摩尔/升(降低16%)。同样,辛伐他汀的效果比非诺贝特更显著(时间×药物:p = 0.03)。非诺贝特治疗期间,高密度脂蛋白胆固醇从1.1毫摩尔/升显著升至1.2毫摩尔/升(升高13%),辛伐他汀治疗期间则无显著变化。辛伐他汀治疗期间,血清甘油三酯从1.3毫摩尔/升降至1.1毫摩尔/升(降低16%),非诺贝特治疗期间降低更为显著,从2.2毫摩尔/升降至1.1毫摩尔/升(降低51%)(时间×药物:p = 0.002)。载脂蛋白B在辛伐他汀治疗期间从1.9克/升降至1.4克/升(降低24%),非诺贝特治疗期间从1.8克/升降至1.4克/升(降低22%)。两种药物耐受性良好,均无显著不良反应。辛伐他汀降低总胆固醇和低密度脂蛋白胆固醇浓度的效果优于非诺贝特,而非诺贝特对甘油三酯的作用更强,这表明两种药物在治疗高脂蛋白血症方面有特定的适应证。