瑞舒伐他汀和阿托伐他汀在原发性高胆固醇血症患者中强制滴定剂量时的疗效和耐受性:ECLIPSE研究结果

Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia: results from the ECLIPSE study.

作者信息

Faergeman Ole, Hill Laurie, Windler Eberhard, Wiklund Olov, Asmar Roland, Duffield Emma, Sosef Froukje

机构信息

Aarhus Sygehus University Hospital, Aarhus, Denmark.

出版信息

Cardiology. 2008;111(4):219-28. doi: 10.1159/000127442. Epub 2008 Apr 23.

Abstract

BACKGROUND

Patients at high risk of cardiovascular disease frequently fail to reach recommended low-density lipoprotein cholesterol (LDL-C) goals, partly because statin doses are not titrated to optimal effect. The ECLIPSE study was designed to compare the efficacy and safety of force-titrated treatment with rosuvastatin (10-40 mg) with that of atorvastatin (10-80 mg) in high-risk patients with hypercholesterolemia.

METHODS

In this 24-week, open-label, randomized, multinational, parallel-group study, 1,036 patients were randomized to rosuvastatin (n = 522) or atorvastatin (n = 514).

RESULTS

At all time points, a significantly greater percentage of patients on rosuvastatin treatment achieved the NCEP ATP III LDL-C goal of <100 mg/dl (2.5 mmol/l), the 2003 European LDL-C target of <2.5 or 3.0 mmol/l (100 or 115 mg/dl) and the LDL-C goal of <70 mg/dl (1.8 mmol/l), a goal suggested for very high-risk patients (p < 0.001 for all). Rosuvastatin also achieved significantly greater improvements in components of the atherogenic lipid profile versus atorvastatin. Both treatments were well tolerated.

CONCLUSION

Rosuvastatin titrated across its recommended dose range provides a more favorable effect on lipoprotein variables than atorvastatin, enabling more high-risk patients to achieve recommended LDL-C goals.

摘要

背景

心血管疾病高危患者常常无法达到推荐的低密度脂蛋白胆固醇(LDL-C)目标,部分原因是他汀类药物剂量未滴定至最佳效果。ECLIPSE研究旨在比较瑞舒伐他汀(10 - 40毫克)与阿托伐他汀(10 - 80毫克)在高胆固醇血症高危患者中进行强制滴定治疗的疗效和安全性。

方法

在这项为期24周的开放标签、随机、多国、平行组研究中,1036例患者被随机分为瑞舒伐他汀组(n = 522)或阿托伐他汀组(n = 514)。

结果

在所有时间点,接受瑞舒伐他汀治疗的患者中达到美国国家胆固醇教育计划成人治疗组第三次报告(NCEP ATP III)LDL-C目标<100毫克/分升(2.5毫摩尔/升)、2003年欧洲LDL-C目标<2.5或3.0毫摩尔/升(100或115毫克/分升)以及<70毫克/分升(1.8毫摩尔/升)(针对极高危患者建议的目标)的患者百分比显著更高(所有比较p < 0.001)。与阿托伐他汀相比,瑞舒伐他汀在致动脉粥样硬化血脂谱成分方面也取得了显著更大的改善。两种治疗耐受性均良好。

结论

在推荐剂量范围内滴定的瑞舒伐他汀对脂蛋白变量的影响比阿托伐他汀更有利,使更多高危患者能够达到推荐的LDL-C目标。

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