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

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• 作者：Christie M. Ballantyne ; Ron C. Hoogeveen ; Joe L. Raya ; Valerie A. Cain ; Mike K. Palmer ; Bj枚rn W. Karlson ; GRAVITY Study Investigators
• 关键词：Rosuvastatin ; Ezetimibe ; Simvastatin ; Hypercholesterolemia ; Low-density lipoprotein cholesterol
• 刊名：Atherosclerosis
• 出版年：January, 2014
• 年：2014
• 卷：232
• 期：1
• 页码：86-93
• 全文大小：782 K

文摘

lass="h4">Objectives

Combination therapy may help high-risk patients achieve low-density lipoprotein cholesterol (LDL-C) goals. Impact of rosuvastatin 10 or 20聽mg plus ezetimibe 10聽mg (RSV10/EZE10 and RSV20/EZE10) has not been fully characterized previously. GRAVITY () compared efficacy, safety and effect on biomarkers of RSV10/EZE10 and RSV20/EZE10 vs. simvastatin 40聽mg and 80聽mg plus EZE10 (SIM40/EZE10 and SIM80/EZE10) in patients with coronary heart disease (CHD) or CHD risk equivalent.

lass="h4">Methods

Adult patients (n聽=聽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.

lass="h4">Results

Significantly greater (p聽<聽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聽mg/dl and <70聽mg/dl with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10. LDL-C was reduced 鈭?0-14% further with combination therapy vs. monotherapy. Statin monotherapy reduced cholesterol and bile acid synthesis biomarkers, ezetimibe reduced 尾-sitosterol (sterol absorption marker), and combination therapy achieved additive reductions in lipoprotein-associated phospholipase A₂ mass and activity, free cholesterol and 7-ketocholesterol. Safety profiles of rosuvastatin/ezetimibe and simvastatin/ezetimibe combinations were comparable.

lass="h4">Conclusion

Co-administration of rosuvastatin 10 or 20聽mg plus ezetimibe achieved significant improvements in lipid profiles in high-risk patients vs. simvastatin 40 or 80聽mg plus ezetimibe.