EFFECTS OF FENOFIBRATE ON PLASMA-LIPIDS - DOUBLE-BLIND, MULTICENTER STUDY IN PATIENTS WITH TYPE-IIA OR TYPE-IIB HYPERLIPIDEMIA
EFFECTS OF FENOFIBRATE ON PLASMA-LIPIDS - DOUBLE-BLIND, MULTICENTER STUDY IN PATIENTS WITH TYPE-IIA OR TYPE-IIB HYPERLIPIDEMIA
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DOI：
10.1161/01.atv.6.6.670
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发表时间：
1986-11-01
期刊：
影响因子：
--
通讯作者：
SUPERKO, HR
中科院分区：
文献类型：
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作者：
BROWN, WV;DUJOVNE, CA;SUPERKO, HR
在 11 个中心招募的 240 名 IIa 型和 IIb 型高胆固醇血症患者中，227 名患者被随机接受非诺贝特（100 mg，每日 3 次）或匹配安慰剂的双盲治疗，疗程为 24 周。其中 192 名患者接受了为期 24 周的进一步研究，在此期间，所有患者均以开放标签方式接受非诺贝特治疗。对于在双盲阶段接受非诺贝特的 92 名 IIa 型患者，血浆总胆固醇 (-18%)、LDL 胆固醇 (-20%)、VLDL 胆固醇 (-38%) 和总甘油三酯 (-38%) 显着降低（与基线相比，p < 0.01）。这些患者的平均血浆 HDL 胆固醇增加了 11% (p < 0.01)。除了治疗前不高的 LDL 外，24 名接受非诺贝特治疗的 IIb 型受试者也出现了类似的变化。安慰剂治疗患者的血脂参数没有显着变化。之前服用安慰剂的 94 名患者在开放期重复了这种变化模式，而服用非诺贝特的 98 名患者保持稳定，总胆固醇和低密度脂蛋白胆固醇进一步小幅降低（分别为-3.8%和-5.5%）。不良反应是治疗早期的一些过敏型皮肤反应以及转氨酶、BUN 或肌酐偶尔升高。结果与非诺贝特欧洲公开试验中获得的结果相似，并且优于脂质研究诊所冠状动脉一级预防试验 (LRC-CPPT) 考来烯胺研究中类似时间观察到的血脂变化。
Of 240 patients with Type IIa and IIb hypercholesterolemia recruited in 11 centers, 227 were randomized to double-blind treatment with either fenofibrate (100 mg three times daily) or matching placebo for 24 weeks. A group of 192 of these patients were studied for a further 24 weeks during which all received fenofibrate in open label fashion. For the 92 Type IIa patients receiving fenofibrate in the double-blind phase, there wre significant reductions (p < 0.01 compared to baseline) in total plasma cholesterol (-18%), LDL-cholesterol (-20%), VLDL-cholesterol (-38%) and total triglycerides (-38%). Mean plasma HDL-cholesterol in these patients increased by 11% (p < 0.01). With the exception of LDL, which was not high before treatment, similar changes were seen in the 24 fenofibrate-treated Type IIb subjects. Lipid parameters of placebo-treated patients did not change significantly. This pattern of change was repeated in the open period for the 94 patients previously on placebo, while the 98 who had been on fenofibrate remained stable with small further reductions in total and LDL cholesterol (-3.8% and -5.5% respectively). Adverse effects were some allergic-type skin reactions early in treatment and an occasional increase in transaminases, BUN, or creatinine. The results were similar to those obtained in European open trials of fenofibrate and were better than the lipid changes seen at comparable times in the Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT) cholestyramine study.