Insull W, Black D, Dujovne C, Hosking J D, Hunninghake D, Keilson L, Knopp R, McKenney J, Stein E, Troendle A J
Lipid Research Clinic, Baylor College of Medicine, Methodist Hospital, Houston.
Arch Intern Med. 1994 Nov 14;154(21):2449-55.
Fluvastatin sodium is a new, entirely synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor that may be an effective lipid-lowering agent in patients whose hyperlipidemia does not respond to dietary therapy. We conducted a study to evaluate the effects of fluvastatin on lipoprotein levels in subjects with primary hypercholesterolemia and to compare the efficacy and safety of two fluvastatin sodium dosing regimens: 20 mg once daily vs 10 mg twice daily.
We conducted a double-blind, placebo-controlled, multicenter trial involving 207 patients with low-density lipoprotein cholesterol levels of 4.15 mmol/L (160 mg/dL) or higher despite dietary intervention and with triglyceride levels of 3.38 mmol/L or lower. Three parallel treatment groups received 6 weeks of treatment with 20 mg of fluvastatin sodium once daily, 10 mg of fluvastatin sodium twice daily, or a placebo.
Total cholesterol and low-density lipoprotein cholesterol levels were reduced from baseline by 16% and 22%, respectively, with 20 mg of fluvastatin sodium once daily (P < .001) and by 17% and 23%, respectively, with 10 mg of fluvastatin sodium twice daily (P < .001). Fluvastatin was well tolerated, and there were no serious clinical or biochemical adverse events ascribable to the drug.
Fluvastatin therapy demonstrated excellent short-term safety and efficacy in reducing total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia. Fluvastatin sodium, the first totally synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to be used in clinical trials, appears to be both effective and well tolerated at 20 mg/d, given in either a single or divided dose.
氟伐他汀钠是一种全新的、完全合成的3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂，对于饮食治疗无效的高脂血症患者，它可能是一种有效的降脂药物。我们开展了一项研究，以评估氟伐他汀对原发性高胆固醇血症患者脂蛋白水平的影响，并比较两种氟伐他汀钠给药方案的疗效和安全性：每日一次20毫克与每日两次10毫克。
我们进行了一项双盲、安慰剂对照、多中心试验，纳入了207例患者，尽管进行了饮食干预，但其低密度脂蛋白胆固醇水平仍为4.15毫摩尔/升（160毫克/分升）或更高，且甘油三酯水平为3.38毫摩尔/升或更低。三个平行治疗组接受为期6周的治疗，分别为每日一次服用20毫克氟伐他汀钠、每日两次服用10毫克氟伐他汀钠或服用安慰剂。
每日一次服用20毫克氟伐他汀钠时，总胆固醇和低密度脂蛋白胆固醇水平分别较基线降低了16%和22%（P <.001）；每日两次服用10毫克氟伐他汀钠时，总胆固醇和低密度脂蛋白胆固醇水平分别较基线降低了17%和23%（P <.001）。氟伐他汀耐受性良好，未出现因药物导致的严重临床或生化不良事件。
氟伐他汀治疗在降低原发性高胆固醇血症患者的总胆固醇和低密度脂蛋白胆固醇水平方面显示出优异的短期安全性和疗效。氟伐他汀钠作为首个用于临床试验的完全合成的3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂，每日20毫克，无论是单次给药还是分次给药，似乎都有效且耐受性良好。
