Sasaki J, Yamamoto K, Kobori S, Setoguchi Y, Sato Y, Matsunaga A, Shichiri M, Sakai T, Kono S, Arakawa K
Department of Internal Medicine, School of Medicine, Fukuoka University, Japan.
Int J Clin Pharmacol Ther. 1995 Jul;33(7):420-6.
Effects of a combination therapy of fluvastatin, a new inhibitor of HMG-CoA reductase, and niceritrol on lipid metabolism were investigated measuring a wide range of parameters in 42 patients with primary hypercholesterolemia. After a wash-out period patients were randomly allocated to 1 of the 2 groups, the fluvastatin-preceding group (G-1) and the niceritrol-preceding group (G-2). In G-1 fluvastatin monotherapy (30 mg/day) significantly decreased total cholesterol (TC) and LDL-cholesterol (LDL-C). There was no significant change in HDL-cholesterol (HDL-C), triglyceride (TG) and lipoprotein (a) (Lp(a)). Further effect in HDL-C and TG was observed after the addition of niceritrol (750 mg/day). On the other hand, in G-2, while niceritrol alone (750 mg/day) produced no significant change in TC, LDL-C, HDL-C, TG and Lp(a), the addition of fluvastatin (30 mg/day) reduced TC and LDL-C levels significantly. Cholesterol ester transfer (CET) activity was significantly reduced by niceritrol monotherapy. After the concomitant use of the 2 drugs CET activity was significantly reduced only in G-2. No significant change in lipoprotein lipase and hepatic triglyceride lipase activities were observed in the 2 groups at either point in time. No serious adverse effect was observed in this study. It is concluded that fluvastatin is an effective drug for lowering LDL-cholesterol and causes no adverse alteration in lipid metabolism. Combination with niceritrol at a dose of 750 mg/day dose not appear to augment or attenuate beneficial effects of fluvastatin.
研究了新型HMG-CoA还原酶抑制剂氟伐他汀与尼克烟酯联合治疗对42例原发性高胆固醇血症患者脂质代谢的影响，测定了一系列参数。在洗脱期后，患者被随机分为2组中的1组，即先使用氟伐他汀组（G-1）和先使用尼克烟酯组（G-2）。在G-1组中，氟伐他汀单药治疗（30毫克/天）显著降低了总胆固醇（TC）和低密度脂蛋白胆固醇（LDL-C）。高密度脂蛋白胆固醇（HDL-C）、甘油三酯（TG）和脂蛋白（a）（Lp(a)）无显著变化。添加尼克烟酯（750毫克/天）后，观察到对HDL-C和TG有进一步影响。另一方面，在G-2组中，虽然单独使用尼克烟酯（750毫克/天）对TC、LDL-C、HDL-C、TG和Lp(a)没有显著变化，但添加氟伐他汀（30毫克/天）可显著降低TC和LDL-C水平。尼克烟酯单药治疗可显著降低胆固醇酯转移（CET）活性。两种药物联合使用后，仅G-2组的CET活性显著降低。在两个时间点的两组中，脂蛋白脂肪酶和肝甘油三酯脂肪酶活性均未观察到显著变化。本研究未观察到严重不良反应。结论是氟伐他汀是降低LDL-C的有效药物，且不会引起脂质代谢的不良改变。与750毫克/天剂量的尼克烟酯联合使用似乎不会增强或减弱氟伐他汀的有益作用。
