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西立伐他汀与洛伐他汀治疗原发性高胆固醇血症的随机双盲对照研究。

A randomized, double-blind comparison of cerivastatin and lovastatin for treatment of primary hypercholesterolemia.

作者信息

Yu Wen-Chung, Chen Chen-Huan, Tsao Husan-Ming, Ding Yu-An

机构信息

Department of Medicine, Taipei Veterans General Hospital, Taiwan, ROC.

出版信息

Zhonghua Yi Xue Za Zhi (Taipei). 2002 Jun;65(6):260-7.

Abstract

BACKGROUND

The efficacy and safety of the new statin, cerivastatin, in the Chinese patients with primary hypercholesterolemia remains to be determined.

METHODS

In this prospective, double-blind, parallel-group study, patients with primary hypercholesterolemia were randomized to treatment with cerivastatin, 0.3 mg (n = 21) or lovastatin, 20 mg (n = 22), for 8 weeks. The primary efficacy variable was percentage change of low-density lipoprotein (LDL) cholesterol from baseline. The secondary efficacy variables were percentage change of total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol. RESULTS.:Both cerivastatin and lovastatin effectively reduced LDL cholesterol (-33.2% vs. -29.3%, p = 0.63), total cholesterol (-25% vs. -20%, p = 0.10), and triglycerides (-21% vs. -14%,p = 0.27) (all p < 0.0001 for comparison with baseline), and slight increased HDL cholesterol (+2% vs. +8%, p = 0.008) over the 8-week treatment period. The LDL cholesterol responsive rates according to the recommendations from the National Cholesterol Educational Panel (NCEP) were 43% and 32% for cerivastatin and lovastatin, respectively. The adverse event profiles of cerivastatin and lovastatin were similar.

CONCLUSIONS

Cerivastatin 0.3 mg once daily is as effective and safe as lovastatin 20 mg once daily in lowering LDL and total cholesterol in Chinese patients with primary hypercholesterolemia.

摘要

背景

新型他汀类药物西立伐他汀在中国原发性高胆固醇血症患者中的疗效和安全性尚待确定。

方法

在这项前瞻性、双盲、平行组研究中,原发性高胆固醇血症患者被随机分为接受西立伐他汀0.3毫克(n = 21)或洛伐他汀20毫克(n = 22)治疗,为期8周。主要疗效变量是低密度脂蛋白(LDL)胆固醇相对于基线的变化百分比。次要疗效变量是总胆固醇、甘油三酯和高密度脂蛋白(HDL)胆固醇的变化百分比。结果:在为期8周的治疗期间,西立伐他汀和洛伐他汀均有效降低了LDL胆固醇(-33.2%对-29.3%,p = 0.63)、总胆固醇(-25%对-20%,p = 0.10)和甘油三酯(-21%对-14%,p = 0.27)(与基线相比,所有p < 0.0001),并使HDL胆固醇略有升高(+2%对+8%,p = 0.008)。根据美国国家胆固醇教育计划(NCEP)的建议,西立伐他汀和洛伐他汀的LDL胆固醇反应率分别为43%和32%。西立伐他汀和洛伐他汀的不良事件谱相似。

结论

对于中国原发性高胆固醇血症患者,每日一次服用0.3毫克西立伐他汀在降低LDL和总胆固醇方面与每日一次服用20毫克洛伐他汀同样有效且安全。

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