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瑞舒伐他汀与阿托伐他汀、辛伐他汀及普伐他汀在实现血脂目标方面的疗效比较:STELLAR试验结果

Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial.

作者信息

McKenney James M, Jones Peter H, Adamczyk M Angeli, Cain Valerie A, Bryzinski Brian S, Blasetto James W

机构信息

National Clinical Research, Richmond, Virginia, USA.

出版信息

Curr Med Res Opin. 2003;19(8):689-98. doi: 10.1185/030079903125002405.

Abstract

In the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) trial, the efficacy of rosuvastatin calcium (Crestor) was compared with that of atorvastatin (Lipitor), simvastatin (Zocor), and pravastatin (Pravachol) for lowering plasma low-density lipoprotein cholesterol (LDL-C) after 6 weeks of treatment. In this multicenter, parallel-group, open-label trial, adults with hypercholesterolemia were randomized to treatments with rosuvastatin 10, 20, 40, or 80 mg, atorvastatin 10, 20, 40, or 80 mg, simvastatin 10, 20, 40, or 80 mg, or pravastatin 10, 20, or 40 mg. Efficacy and safety results from this trial have been previously published. The additional analyses included in this report show that 53% (83/156) to 80% (125/157) of patients in the rosuvastatin 10- to 40-mg groups achieved LDL-C levels < 100 mg/dl (< 2.6 mmol/l), compared with 18% (28/158) to 70% (115/165) of patients who received atorvastatin, 8% (13/165) to 53% (86/163) of patients who received simvastatin, and 1% (1/160) to 8% (13/161) of patients who received pravastatin. Other additional analyses showed that more patients in the rosuvastatin 10- to 40-mg groups than in the comparator groups who were at high risk of coronary heart disease according to National Cholesterol Education Program Adult Treatment Panel (ATP) III, Joint European Societies, or Canadian guidelines achieved the LDL-C goals of < 100 mg/dl (< 2.6 mmol/l) (55% to 77% compared with 0 to 64%), < 3.0 mmol/l (< 116 mg/dl) (76% to 94% compared with 6% to 81%), and < 2.5 mmol/l (< 97 mg/dl) (47% to 69% compared with 0 to 53%), respectively. Results favoring rosuvastatin versus the comparators were also reported for patients: (a) who had triglycerides > or = 200mg/dl (> or = 2.3 mmol/l), and achieved both ATP III LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C) goals (80% to 84% versus 15% to 84%); (b) overall who achieved the Canadian LDL-C goals of < 2.5 (< 97 mg/dl) to < 5.0 mmol/l (< 193 mg/dl) (85% to 91% versus 44% to 86%); and (c) who achieved all 3 Canadian goals for LDL-C, triglycerides (< 3.0 mmol/l [< 266 mg/dl] to < 2.0 mmol/l [< 177 mg/dl]), and the total cholesterol/high-density lipoproteincholesterol ratio (< 4 to < 7) (70% to 83% versus 35% to 79%).

摘要

在“不同剂量瑞舒伐他汀与其他他汀类药物治疗血脂升高的比较(STELLAR)试验”中,比较了瑞舒伐他汀钙(可定)与阿托伐他汀(立普妥)、辛伐他汀(舒降之)和普伐他汀(普拉固)在治疗6周后降低血浆低密度脂蛋白胆固醇(LDL-C)的疗效。在这项多中心、平行组、开放标签试验中,高胆固醇血症成人被随机分配接受10、20、40或80毫克瑞舒伐他汀、10、20、40或80毫克阿托伐他汀、10、20、40或80毫克辛伐他汀或10、20或40毫克普伐他汀治疗。该试验的疗效和安全性结果此前已发表。本报告中的其他分析表明,瑞舒伐他汀10至40毫克组中53%(83/156)至80%(125/157)的患者LDL-C水平<100毫克/分升(<2.6毫摩尔/升),相比之下,接受阿托伐他汀治疗的患者为18%(28/158)至70%(115/165),接受辛伐他汀治疗的患者为8%(13/165)至53%(86/163),接受普伐他汀治疗的患者为1%(1/160)至8%(13/161)。其他额外分析表明,根据美国国家胆固醇教育计划成人治疗小组(ATP)III、欧洲心脏病学会联合组织或加拿大指南,处于冠心病高风险的瑞舒伐他汀10至40毫克组患者比对照组成员达到LDL-C目标<100毫克/分升(<2.6毫摩尔/升)(55%至77%对0至64%)、<3.0毫摩尔/升(<116毫克/分升)(76%至94%对6%至81%)和<2.5毫摩尔/升(<97毫克/分升)(47%至69%对0至53%)的比例更高。对于以下患者也报告了瑞舒伐他汀优于对照药物的结果:(a)甘油三酯≥200毫克/分升(≥2.3毫摩尔/升)且同时达到ATP III LDL-C和非高密度脂蛋白胆固醇(非HDL-C)目标的患者(80%至84%对15%至84%);(b)总体上达到加拿大LDL-C目标<2.5(<97毫克/分升)至<5.0毫摩尔/升(<193毫克/分升)的患者(85%至91%对44%至86%);以及(c)达到加拿大LDL-C、甘油三酯(<3.0毫摩尔/升[<266毫克/分升]至<2.0毫摩尔/升[<177毫克/分升])和总胆固醇/高密度脂蛋白胆固醇比率(<4至<7)这三项加拿大目标的患者(70%至83%对35%至79%)。

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