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氟伐他汀钠治疗伴有轻度和中度原发性动脉高血压的高胆固醇血症患者的临床试验

[Clinical trial with sodium fluvastatin in patients with hypercholesterolemia associated with mild and moderate essential arterial hypertension].

作者信息

Granero R, Linfa-Homes G, Isaacura-López C, Goyo A, Flores-Finizola A, Sira A

机构信息

Centro Cardiovascular Centroccidental-ASCARDIO, Barquisimeto, Venezuela.

出版信息

Invest Clin. 1997 Jun;38(2):63-72.

PMID:9296641
Abstract

High serum cholesterol and LDL-cholesterol level and high blood pressure are risk factors for cardiovascular disease (CVD). CVD risk factors usually occur simultaneously, fact that enhance personal and population CVD risk. Data from interventional studies suggest that reducing CAD risk factors significantly lowered risk of CAD. Fluvastatin, a statine, has been used in hypercholesterolemic populations. We report on a clinical trial (random selection) of fluvastatin vs. placebo on hipercholesterolemic patients (total cholesterol > or = 240 mg/dl and/or low-density lipoprotein cholesterol (LDL-C) > or = 160 mg/dl) on treatment of mild to moderate high blood pressure. Forty Latin-American patients were randomized to placebo or 40 mg per day for 8 weeks of fluvastatin. Fluvastatin patients had a clinical and statistical significant reduction on total cholesterol (27.7%) and LDL-C (39.1%) Vs a non-significant reduction on the placebo group (6.9% total cholesterol and 9.1% LDL-C). One patient had elevated aspartate (AST) and alanine (ALT) aminotransferases (three times the local laboratory upper normal levels) associated with a chronic alcohol consumption, reverted 6 weeks after protocol completion. There was no important secondary effects; also there was no differences on this regard between placebo and verum group. Fluvastatin proved to be safe and well tolerated for this group of patients under a wide range of high blood pressure treatment.

摘要

高血清胆固醇和低密度脂蛋白胆固醇水平以及高血压是心血管疾病(CVD)的危险因素。CVD危险因素通常同时出现,这一事实增加了个人和人群患CVD的风险。干预性研究数据表明,降低CAD危险因素可显著降低CAD风险。氟伐他汀,一种他汀类药物,已用于高胆固醇血症人群。我们报告了一项针对患有轻度至中度高血压的高胆固醇血症患者(总胆固醇≥240mg/dl和/或低密度脂蛋白胆固醇(LDL-C)≥160mg/dl)的氟伐他汀与安慰剂的临床试验(随机选择)。40名拉丁裔患者被随机分为接受安慰剂组或每天40mg氟伐他汀治疗8周组。与安慰剂组(总胆固醇降低6.9%,LDL-C降低9.1%)相比无显著降低不同,氟伐他汀组患者的总胆固醇(降低27.7%)和LDL-C(降低39.1%)有临床和统计学意义的显著降低。一名患者因长期饮酒出现天冬氨酸(AST)和丙氨酸(ALT)转氨酶升高(是当地实验室正常上限水平的三倍),在方案完成6周后恢复正常。未出现重要的副作用;在这方面安慰剂组和治疗组之间也没有差异。在广泛的高血压治疗范围内,氟伐他汀被证明对这类患者安全且耐受性良好。

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