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在高胆固醇血症患者中,与普伐他汀和辛伐他汀相比,瑞舒伐他汀能更有效地降低低密度脂蛋白胆固醇:一项随机双盲研究。

Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study.

作者信息

Paoletti R, Fahmy M, Mahla G, Mizan J, Southworth H

机构信息

Department of Pharmacological Sciences, University of Milan, Milan, Italy.

出版信息

J Cardiovasc Risk. 2001 Dec;8(6):383-90. doi: 10.1177/174182670100800608.

DOI:10.1177/174182670100800608
PMID:11873095
Abstract

BACKGROUND

Rosuvastatin (Crestor), a new, highly efficacious statin, has demonstrated dose-dependent low-density lipoprotein cholesterol (LDL-C) reductions of up to 65% in a dose-ranging programme with doses of 1 to 80 mg.

DESIGN

A randomized, double-blind multicentre trial compared rosuvastatin with commonly used starting doses of pravastatin and simvastatin to determine relative efficacy in LDL-C reduction and impact on other lipid parameters in primary hypercholesterolaemia.

METHODS AND RESULTS

A total of 502 patients (greater-than-or-equal 18 years; LDL-C greater-than-or-equal 4.14 mmol/l [160 mg/dl] and < 6.50 mmol/l [250 mg/dl] and triglycerides less-than-or-equal 4.52 mmol/l [400 mg/dl]) were randomized to 12 weeks of rosuvastatin 5 mg (n = 120) or 10 mg (n = 115), pravastatin 20 mg (n=]137) or simvastatin 20 mg (n = 130). Rosuvastatin 5 and 10 mg reduced LDL-C by 42 and 49%, respectively, compared with 28% for pravastatin (P < 0.001 versus both rosuvastatin doses) and 37% for simvastatin (P < 0.01 versus rosuvastatin 5 mg; P < 0.001 versus 10[?]mg). National Cholesterol Education Program Adult Treatment Panel II (NCEP ATP II) goals were achieved by 87% of rosuvastatin 10[?]mg patients, 71% of rosuvastatin 5[?]mg patients, 53% of pravastatin patients, and 64% of simvastatin patients; similar proportions of patients achieved NCEP ATP III goals. European Atherosclerosis Society (EAS) goals were achieved by 83, 63, 20 and 50% of patients, respectively. All study treatments were well tolerated.

CONCLUSIONS

Both doses of rosuvastatin were more effective than pravastatin and simvastatin in meeting NCEP ATP II and EAS LDL-C targets. Rosuvastatin 10 mg was more effective than pravastatin and simvastatin in meeting NCEP ATP III targets.

摘要

背景

瑞舒伐他汀(可定)是一种新型高效他汀类药物,在一项剂量范围研究中,剂量为1至80毫克时,已证明其能使低密度脂蛋白胆固醇(LDL-C)呈剂量依赖性降低,降幅高达65%。

设计

一项随机、双盲多中心试验将瑞舒伐他汀与普伐他汀和辛伐他汀常用起始剂量进行比较,以确定在原发性高胆固醇血症中降低LDL-C的相对疗效以及对其他血脂参数的影响。

方法与结果

总共502例患者(年龄大于或等于18岁;LDL-C大于或等于4.14毫摩尔/升[160毫克/分升]且小于6.50毫摩尔/升[250毫克/分升],甘油三酯小于或等于4.52毫摩尔/升[400毫克/分升])被随机分为接受12周的瑞舒伐他汀5毫克(n = 120)或10毫克(n = 115)、普伐他汀20毫克(n = 1)137或辛伐他汀20毫克(n = 130)治疗。瑞舒伐他汀5毫克和10毫克分别使LDL-C降低42%和49%,相比之下,普伐他汀降低28%(与瑞舒伐他汀两种剂量相比,P < 0.001),辛伐他汀降低37%(与瑞舒伐他汀5毫克相比,P < 0.01;与10毫克相比,P < 0.001)。接受瑞舒伐他汀10毫克治疗的患者中有87%、接受瑞舒伐他汀5毫克治疗的患者中有71%、接受普伐他汀治疗的患者中有53%、接受辛伐他汀治疗的患者中有64%达到了美国国家胆固醇教育计划成人治疗小组II(NCEP ATP II)目标;达到NCEP ATP III目标的患者比例相似。欧洲动脉粥样硬化学会(EAS)目标分别在83%、63%、20%和50%的患者中实现。所有研究治疗耐受性良好。

结论

两种剂量的瑞舒伐他汀在达到NCEP ATP II和EAS的LDL-C目标方面均比普伐他汀和辛伐他汀更有效。瑞舒伐他汀10毫克在达到NCEP ATP III目标方面比普伐他汀和辛伐他汀更有效。

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