依折麦布和辛伐他汀联合用药VS阿托伐他汀:安全性和疗效上更具优越性

2012-04-13 16:50 来源:丁香园 作者:
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依折麦布和辛伐他汀联合用药VS阿托伐他汀:安全性和疗效上更具优越性
 
该研究着力于对依折麦布与辛伐他汀联合用药与阿托伐他汀的疗效和安全性的比较。结果显示,虽然两种治疗方式对患者都有很好的耐受性,但依折麦布和辛伐他汀联合用药降低LDL-C和升高HDL-C的效果更佳,提示依折麦布和辛伐他汀联合用药在疗效和安全性上有其独到的优越性。
 
Efficacy and Safety of Ezetimibe Co-Administered With Simvastatin Compared With Atorvastatin in Adults With Hypercholesterolemia
 
This study compared the efficacy and safety of co-administered ezetimibe+simvastatin with atorvastatin monotherapy in adults with hypercholesterolemia. Seven hundred eighty-eight patients were randomized 1:1:1 to 3 treatment groups; each group was force-titrated over four 6-week treatment periods: (1) 10 mg of atorvastatin as the initial dose was titrated to 20, 40, and 80 mg; (2) coadministration of 10 mg of ezetimibe and 10 mg of simvastatin (10/10 mg) was titrated to 10/20, 10/40, and 10/80 mg of ezetimibe+simvastatin; and (3) co-administration of 10/20 mg of ezetimibe+simvastatin was titrated to 10/40 mg (for 2 treatment periods) and 10/80 mg of ezetimibe+simvastatin. Key efficacy measures included percent changes in low-density lipoprotein cholesterol (LDL) and high-density lipoprotein cholesterol (HDL) from baseline to the ends of (1) treatment periods 1 and 2 (for LDL cholesterol) comparing co-administration of 10/20 mg and 10/10 mg of ezetimibe+simvastatin with 10 mg of atorvastatin and (2) treatment period 4 (for LDL cholesterol and HDL cholesterol) comparing co-administration of 10/80 mg of ezetimibe+simvastatin with 80 mg of atorvastatin. Baseline LDL and HDL cholesterol levels were comparable between treatment groups. 
 
At the end of treatment period 1, the mean decrease of LDL cholesterol was significantly (p <0.001) greater for co-administration of 10/10 mg and 10/20 mg of ezetimibe+simvastatin than for 10 mg of atorvastatin. At the end of treatment period 4 and after comparing maximum doses, co-administration of 10/80 mg of ezetimibe+simvastatin was superior to 80 mg of atorvastatin in the percent LDL cholesterol decrease (59.4% vs 52.5%, p <0.001) and HDL cholesterol increase (12.3% vs 6.5%; p <0.001). All treatments were well tolerated. Thus, a greater LDL cholesterol decrease and HDL cholesterol increase were attained by treating patients with co-administration of ezetimibe and simvastatin than with atorvastatin.

编辑: 袁小燕

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