Steinmetz A, Schwartz T, Hehnke U, Kaffarnik H
Abteilung für Endokrinologie und Stoffwechsel, Philipps-Universität Marburg, Germany.
J Cardiovasc Pharmacol. 1996 Apr;27(4):563-70. doi: 10.1097/00005344-199604000-00016.
In 12 weeks of active treatment, we compared the efficacy and safety of a new (micronized) formulation of fenofibrate (F) (200 mg/day) with that of simvastatin (S) (20 mg/day), an inhibitor of hydroxy-methyl-glutaryl coenzyme A (HMG-CoA)-reductase. Men and women with primary hyperlipoproteinemia (HLP) with low-density lipoprotein (LDL) cholesterol level 180-300 mg/dl and triglyceride level < 500 mg/dl had dietary treatment for 8 weeks, and 133 (2 of 3 type IIa, 1 of 3 type IIb HLP) were randomized. The decrease in total cholesterol differed between type IIa patients (F - 17.9 vs. S - 25.8%), the decrease in triglyceride levels between the type II b groups (F - 52.8 vs. S - 14%), whereas the degree of decrease in LDL cholesterol (F - 20.9 vs. S - 34.9%) differed among all patients. Despite the difference in LDL cholesterol decrease, no difference was noted in total apolipoprotein (apo) B lowering (F - 20.8 and S - 26.5%). Increases in high-density lipoprotein (HDL) cholesterol (F + 18.5 vs. S + 15%) differed specifically in type IIb patients (F + 33.6 vs. S + 11.4%), accompanied by a more pronounced increase in apo AI with fenofibrate (F + 10.5% vs. S no change). Improvement in the ratios of total cholesterol/HDL cholesterol and apo AI/apo B occurred similarly with both drugs. Only fenofibrate, not simvastatin, decreased both fibrinogen (-10.3 vs. + 3.6%) and uric acid (-25% vs. no change) in type IIa and type IIb patients. Safety parameters reflected drug-specific known side effects, underscoring the safety of both drugs in addition to their efficacy in lipid lowering. Besides its advantages in type IIb hyperlipidemia, micronized fenofibrate proved a potent drug in decreasing total and LDL cholesterol and in very effectively decreasing apo B-containing lipoproteins, which is a recommendation for its use in primary hypercholesterolemia.
在为期12周的积极治疗中，我们比较了非诺贝特新的（微粒化）制剂（F）（200毫克/天）与羟甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂辛伐他汀（S）（20毫克/天）的疗效和安全性。患有原发性高脂血症（HLP）且低密度脂蛋白（LDL）胆固醇水平为180 - 300毫克/分升、甘油三酯水平<500毫克/分升的男性和女性接受了8周的饮食治疗，133例患者（3例IIa型中的2例，3例IIb型HLP中的1例）被随机分组。IIa型患者的总胆固醇降低幅度有所不同（F组为17.9%，S组为25.8%），IIb组之间甘油三酯水平的降低幅度也不同（F组为52.8%，S组为14%），而所有患者中LDL胆固醇的降低程度也有所不同（F组为20.9%，S组为34.9%）。尽管LDL胆固醇降低幅度存在差异，但在总载脂蛋白（apo）B降低方面未发现差异（F组为20.8%，S组为26.5%）。高密度脂蛋白（HDL）胆固醇的升高在IIb型患者中存在差异（F组升高18.5%，S组升高15%），具体为（F组升高33.6%，S组升高11.4%），同时非诺贝特使apo AI升高更为显著（F组升高10.5%，S组无变化）。两种药物在总胆固醇/HDL胆固醇和apo AI/apo B比值改善方面相似。仅非诺贝特而非辛伐他汀可降低IIa型和IIb型患者的纤维蛋白原（-10.3%对+3.6%）和尿酸（-25%对无变化）。安全性参数反映了药物特有的已知副作用，这突出了两种药物在降脂疗效之外的安全性。除了在IIb型高脂血症方面的优势外，微粒化非诺贝特在降低总胆固醇和LDL胆固醇以及非常有效地降低含apo B脂蛋白方面被证明是一种有效的药物，这为其在原发性高胆固醇血症中的应用提供了依据。
