Efficacy, safety and effect on biomarkers related to cholesterol and lipoprotein metabolism of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg vs. simvastatin 40 or 80 mg plus ezetimibe 10 mg in high-risk patients: Results of the GRAVITY randomized study

被引：36

作者：

Ballantyne, Christie M. ^{[1
,2
]}

Hoogeveen, Ron C. ^{[1
,2
]}

Raya, Joe L. ^{[1
,2
]}

Cain, Valerie A. ^{[3
]}

Palmer, Mike K. ^{[4
]}

Karlson, Bjorn W. ^{[5
,6
]}

机构：

[1] Baylor Coll Med, Dept Med, Houston, TX 77030 USA

[2] Methodist DeBakey Heart & Vasc Ctr, Ctr Cardiovasc Dis Prevent, Houston, TX USA

[3] AstraZeneca, Wilmington, DE USA

[4] Keele Univ, Keele ST5 5BG, Staffs, England

[5] AstraZeneca R&D, Molndal, Sweden

[6] Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Mol & Clin Med, Gothenburg, Sweden

来源：

ATHEROSCLEROSIS | 2014年 / 232卷 / 01期

基金：

美国国家卫生研究院;

关键词：

Rosuvastatin; Ezetimibe; Simvastatin; Hypercholesterolemia; Low-density lipoprotein cholesterol; BILE-ACID SYNTHESIS; STATIN MONOTHERAPY; PLASMA; HYPERCHOLESTEROLEMIA; OXYSTEROLS; ABSORPTION; STEROLS;

D O I：

10.1016/j.atherosclerosis.2013.10.022

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives: Combination therapy may help high-risk patients achieve low-density lipoprotein cholesterol (LDL-C) goals. Impact of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg (RSV10/EZE10 and RSV20/EZE10) has not been fully characterized previously. GRAVITY (NCT00525824) compared efficacy, safety and effect on biomarkers of RSV10/EZE10 and RSV20/EZE10 vs. simvastatin 40 mg and 80 mg plus EZE10 (SIM40/EZE10 and SIM80/EZE10) in patients with coronary heart disease (CHD) or CHD risk equivalent. Methods: Adult patients (n = 833) were randomized to RSV10/EZE10, RSV20/EZE10, SIM40/EZE10 or SIM80/EZE10. Following a 6-week dietary lead-in, patients received 6 weeks' statin monotherapy followed by same statin dose plus ezetimibe for 6 more weeks. Primary endpoint was LDL-C change from baseline to 12 weeks. Results: Significantly greater (p < 0.05) reductions in LDL-C and other atherogenic lipids were observed with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10. A significantly greater proportion of patients achieved LDL-C goals of < 100 mg/dl and < 70 mg/dl with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10. LDL-C was reduced w10-14% further with combination therapy vs. monotherapy. Statin monotherapy reduced cholesterol and bile acid synthesis biomarkers, ezetimibe reduced beta-sitosterol (sterol absorption marker), and combination therapy achieved additive reductions in lipoprotein-associated phospholipase A(2) mass and activity, free cholesterol and 7-ketocholesterol. Safety profiles of rosuvastatin/ezetimibe and simvastatin/ezetimibe combinations were comparable. Conclusion: Co-administration of rosuvastatin 10 or 20 mg plus ezetimibe achieved significant improvements in lipid profiles in high-risk patients vs. simvastatin 40 or 80 mg plus ezetimibe. (C) 2013 Elsevier Ireland Ltd. All rights reserved.

引用

页码：86 / 93

页数：8

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