Efficacy and safety of simvastatin 80 mg/day in hypercholesterolemic patients. The Expanded Dose Simvastatin U.S. Study Group.
Efficacy and safety of simvastatin 80 mg/day in hypercholesterolemic patients. The Expanded Dose Simvastatin U.S. Study Group.
复制标题
辛伐他汀 80 毫克/天对高胆固醇血症患者的疗效和安全性。
DOI：
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发表时间：
1998
影响因子：
2.8
通讯作者：
Y. Mitchel
中科院分区：
文献类型：
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作者：
E. Stein;M. Davidson;A. Dobs;H. Schrott;C. Dujovne;H. Bays;S. Weiss;M. Melino;M. Stepanavage;Y. Mitchel
这项随机、多中心、双盲、平行分组研究旨在评估辛伐他汀80 mg/d的调脂疗效和安全性，该剂量是目前最大推荐剂量的两倍。在美国的20个中心，521名男性和女性高胆固醇血症患者按2：3的比例随机分配，分别每天服用一次辛伐他汀40或80毫克，并配合降脂饮食，持续24周。患者符合国家胆固醇教育计划(NCEP)低密度脂蛋白(LDL)胆固醇药物治疗标准。在18周和24周，40毫克组和80毫克组的平均低密度脂蛋白胆固醇从基线水平下降的百分比(95%可信区间)分别为38%(-40到-36)和46%(-47到-45)(P<；0.001)。服用40毫克和80毫克剂量的患者中，有三分之一的人的低密度脂蛋白胆固醇分别降低了46%和53%。每天服用80毫克的患者，载脂蛋白B、总胆固醇和甘油三酯的下降幅度也明显更大。辛伐他汀在两组中耐受性良好。80毫克组中有两名患者(0.6%)发生了肌病。在40毫克组和80毫克组中，分别有3名(1.0%)和6名(1.9%)患者出现了连续的临床显著肝转氨酶升高(p=0.486)。总之，每天服用辛伐他汀80毫克可显著降低低密度脂蛋白胆固醇，使大多数患者达到他们的NCEP目标水平；它还具有极好的安全性和耐受性。
This randomized, multicenter, double-blind parallel-group study was performed to evaluate the lipid-altering efficacy and safety of simvastatin 80 mg/day, a dose twice the current maximum recommended dose. At 20 centers in the United States, 521 male and female hypercholesterolemic patients were randomly assigned in a ratio of 2:3 to receive simvastatin 40 or 80 mg once daily, respectively, for 24 weeks in conjunction with a lipid-lowering diet. Patients met National Cholesterol Education Program (NCEP) low-density lipoprotein (LDL) cholesterol criteria for pharmacologic treatment. The mean percentage reductions (95% confidence intervals) from baseline in LDL cholesterol averaged at weeks 18 and 24 were 38% (-40 to -36) and 46% (-47 to -45) for the 40- and 80-mg groups, respectively (p <0.001 between groups). One third of patients on the 40- and 80-mg doses achieved an LDL cholesterol reduction of 46% and > or = 53%, respectively. Decreases in apolipoprotein B, total cholesterol, and triglycerides were also significantly greater among patients receiving 80 mg/day. Simvastatin was well tolerated in both groups. Two patients (0.6%) in the 80-mg group developed myopathy. Consecutive, clinically significant hepatic transaminase elevations occurred in 3 (1.0%) and 6 (1.9%) patients in the 40- and 80-mg groups, respectively (p= 0.486). In conclusion, simvastatin 80 mg/day provided substantial reductions in LDL cholesterol, allowing most patients to reach their NCEP target levels; it also had an excellent safety and tolerability profile.