对患有或未患有颈动脉疾病的高胆固醇血症患者进行为期一年的阿托伐他汀治疗。

One-year atorvastatin treatment in hypercholesterolemic patients with or without carotid artery disease.

作者信息

Avellone G, Di Garbo V, Abruzzese G, Campisi D, De Simone R, Raneli G, Licata G

机构信息

Institute of Clinical Medicine, Lipid and Thrombosis Research Centre, University of Palermo, Palermo, Italy.

出版信息

Int Angiol. 2006 Mar;25(1):26-34.

PMID:16520721

Abstract

AIM

Statins are the drugs of choice in heterozygous familial hypercholesterolemia (FH), which has a high risk of premature cardiovascular events including myocardial infarction, stroke, and surgical revascularization.

METHODS

A 1-year open-label study was conducted to test the efficacy and tolerability of Atorvastatin titrated to the target, in proven FH patients and to evaluate certain inflammatory parameters. One hundred and two FH patients (44 men and 58 women; mean age 58.7+/-3.6 years) were included in the study. After evaluation using the B-mode duplex scanning system of extracranial carotid arteries, the patients were divided into two groups: Group 1 (15 men, 25 women) with carotid plaques or intima-media thickness (IMT) greater than 0.95 mm and Group 2 (30 men, 32 women) without carotid plaques or IMT less than 0.95 mm. After a 6-week hypolipemic diet phase all the patients were treated with atorvastatin titrated to achieve a low density lipoprotein (LDL-C) <100 mg/dL. Patients with carotid lesions were also submitted to an oral fixed dose of aspirin 100 mg/day.

RESULTS

In patients without and with carotid lesions, atorvastatin treatment (mean dosage: 23.5 mg/day) reduced triglycerides by 8.7% (P<0.005) and 10.6% (P<0.005), total cholesterol by 41.5% (P<0.005) and 42.6% (P<0.005), LDL-C by 55.8% (P<0.005) and 57.3% (P<0.005) and apolipoprotein B by 38.3% (P<0.005) and 37.2% (P<0.005) respectively, and increased the mean levels of high density lipoprotein cholesterol (HDL-C) by 8.7% (P<0.005) and 11% (P<0.005), and apolipoprotein A-I by 3.2% (P<0.05) and 3.3%, respectively. In both groups of patients the mean decrease (52 weeks) of fibrinogen was 19.8% (P<0.005) and 10.4% (P<0.005), respectively and of high sensitivity C-reactive protein (hs-CRP), 36.2% (P<0.005) and 38.2% (P<0.005), respectively. No variation of the parameters of safety and clinical tolerability of the drugs administered was observed. No variation in hematocrit in the patients taking ASA treatment was observed.

CONCLUSIONS

In FH patients, 1-year atorvastatin treatment titrated to the target (LDL-C <100 mg/dL) was well tolerated and improved serum lipid levels and inflammatory parameters.

摘要

目的

他汀类药物是杂合子家族性高胆固醇血症（FH）的首选药物，该病发生包括心肌梗死、中风和外科血管重建在内的过早心血管事件的风险很高。

方法

开展一项为期1年的开放标签研究，以测试阿托伐他汀滴定至目标剂量在确诊的FH患者中的疗效和耐受性，并评估某些炎症参数。102例FH患者（44例男性和58例女性；平均年龄58.7±3.6岁）纳入该研究。使用颅外颈动脉B型双功扫描系统评估后，患者被分为两组：第1组（15例男性，25例女性）有颈动脉斑块或内膜中层厚度（IMT）大于0.95mm，第2组（30例男性，32例女性）无颈动脉斑块或IMT小于0.95mm。经过6周的低脂饮食阶段后，所有患者均接受阿托伐他汀滴定治疗以实现低密度脂蛋白（LDL-C）<100mg/dL。有颈动脉病变的患者还口服固定剂量的阿司匹林100mg/天。

结果

在无颈动脉病变和有颈动脉病变的患者中，阿托伐他汀治疗（平均剂量：23.5mg/天）使甘油三酯分别降低8.7%（P<0.005）和10.6%（P<0.005），总胆固醇分别降低41.5%（P<0.005）和42.6%（P<0.005），LDL-C分别降低55.8%（P<0.005）和57.3%（P<0.005），载脂蛋白B分别降低38.3%（P<0.005）和37.2%（P<0.005），并使高密度脂蛋白胆固醇（HDL-C）平均水平分别升高8.7%（P<0.005）和11%（P<0.005），载脂蛋白A-I分别升高3.2%（P<0.05）和3.3%。两组患者纤维蛋白原平均降低（52周）分别为19.8%（P<0.005）和10.4%（P<0.005），高敏C反应蛋白（hs-CRP）分别降低36.2%（P<0.005）和38.2%（P<0.005）。未观察到所给药药物的安全性和临床耐受性参数有变化。接受阿司匹林治疗的患者血细胞比容未发生变化。