Comparative dose efficacy study of Atorvastatin versus Simvastatin, Pravastatin, Lovastatin, and Fluvastatin in patients with hypercholesterolemia (The CURVES study)

Comparative dose efficacy study of Atorvastatin versus Simvastatin, Pravastatin, Lovastatin, and Fluvastatin in patients with hypercholesterolemia (The CURVES study)
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DOI:
10.1016/s0002-9149(97)00965-x
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发表时间:
1998-03-01
影响因子:
2.8
通讯作者:
Hunninghake, D
Hunninghake, D
中科院分区:
医学3区
文献类型:
--
作者:
Jones, P;Kafonek, S;Hunninghake, D

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这项为期8周的多中心、随机、开放、平行分组研究的目的是评价3-羟基-3-甲基戊二酰辅酶A(HMG-CoA)还原酶抑制剂阿托伐他汀10、20、40和80 mg与辛伐他汀10、20和40 mg、普伐他汀10、20和40 mg、洛伐他汀20、40和80 mg以及氟伐他汀20和40 mg的比较剂量效应。研究人员纳入了534名高胆固醇血症患者(低密度脂蛋白胆固醇大于或等于160mgdl[4.2mmoL/L],甘油三酯小于或等于400mgdl[4.5mmoL/L])。疗效终点是从基线到治疗结束(第8周)血浆低密度脂蛋白胆固醇(主要)、总胆固醇、甘油三酯和高密度脂蛋白胆固醇浓度的平均百分比变化。与同等剂量的辛伐他汀、普伐他汀、洛伐他汀和氟伐他汀相比,阿托伐他汀10、20和40毫克对低密度脂蛋白胆固醇的降幅更大(p小于或等于0.01),分别为-38%、-46%和-51%。阿托伐他汀10毫克可使低密度脂蛋白降低相当于或大于(p小于或等于0.02)辛伐他汀10、20和40毫克,普伐他汀10、20和40毫克,洛伐他汀20和40毫克,以及氟伐他汀20和40毫克。与同等剂量的辛伐他汀、普伐他汀、洛伐他汀和氟伐他汀相比,阿托伐他汀10、20和40毫克对总胆固醇的降幅更大(p小于或等于0.01)。所有研究的还原酶抑制剂都具有相似的耐受性。没有出现血清转氨酶持续升高或肌炎的病例。(C)1998年,由Excerpta Medica,Inc.
The objective of this multicenter, randomized, open-label, parallel-group, 8-week study was to evaluate the comparative dose efficacy of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor atorvastatin 10, 20, 40, and 80 mg compared with simvastatin 10, 20, and 40 mg, pravastatin 10, 20, and 40 mg, lovastatin 20, 40, and 80 mg, and fluvastatin 20 and 40 mg. investigators enrolled 534 hypercholesterolemic patients (low-density lipoprotein [LDL] cholesterol greater than or equal to 160 mg/dl [4.2 mmol/L] and triglycerides less than or equal to 400 mg/dl [4.5 mmol/L]). The efficacy end points were mean percent change in plasma LDL cholesterol (primary), total cholesterol, triglycerides, and high-density lipoprotein cholesterol concentrations from baseline to the end of treatment (week 8). Atorvastatin 10, 20, and 40 mg produced greater (p less than or equal to 0.01) reductions in LDL cholesterol, -38%, -46%, and -51%, respectively, than the milligram equivalent doses of simvastatin, pravastatin, lovastatin, and fluvastatin. Atorvastatin 10 mg produced LDL cholesterol reductions comparable to or greater than (p less than or equal to 0.02) simvastatin 10, 20, and 40 mg, pravastatin 10, 20, and 40 mg, lovastatin 20 and 40 mg, and fluvastatin 20 and 40 mg. Atorvastatin 10, 20, and 40 mg produced greater (p less than or equal to 0.01) reductions in total cholesterol than the milligram equivalent doses of simvastatin, pravastatin, lovastatin, and fluvastatin. All reductase inhibitors studied had similar tolerability. There were no incidences of persistent elevations in serum transaminases or myositis. (C) 1998 by Excerpta Medica, Inc.