Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (Results from the EXPLORER study)
Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (Results from the EXPLORER study)
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DOI：
10.1016/j.amjcard.2006.10.022
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发表时间：
2007-03-01
影响因子：
2.8
通讯作者：
Duffield, Emma
中科院分区：
文献类型：
--
作者：
Ballantyne, Christie M.;Weiss, Robert;Duffield, Emma
有冠心病风险的患者接受他汀类药物单药治疗可能无法达到推荐的低密度脂蛋白（LDL）胆固醇目标。本研究旨在研究罗司他汀40 mg单药或与依折麦布10 mg联合治疗冠心病高危患者的疗效和安全性。469例患者被随机分配接受罗司他汀单药治疗或与依折麦布联合治疗6周。主要终点是第6周达到成人治疗组III（ATP III）LDL胆固醇目标（< 100 mg/dl）的患者百分比。次要终点包括达到其他ATP III和2003年欧洲血脂目标的患者百分比，血脂、脂蛋白和炎症参数较基线的变化，以及安全性和耐受性。接受瑞舒伐他汀/依折麦布治疗的患者达到ATP III LDL胆固醇目标（< 100 mg/dl，94.0% vs 79.1%，p < 0.001）和极高危患者可选LDL胆固醇目标（< 70 mg/dl）的患者显著多于接受瑞舒伐他汀单药治疗的患者（79.6% vs 35.0%，p < 0.001）。瑞舒伐他汀/依折麦布联合用药降低LDL胆固醇的作用显著高于瑞舒伐他汀（-69.8% vs-57.1%，p < 0.001）。使用瑞舒伐他汀/依折麦布后，脂质/脂蛋白谱的其他组分也显著改善（p < 0.001）。两种治疗通常耐受良好。瑞舒伐他汀40 mg可有效改善该高风险人群的致动脉粥样硬化脂质谱。瑞舒伐他汀与依折麦布10 mg联合用药可使LDL胆固醇降低幅度更大，并使更多患者达到LDL胆固醇目标。总之，瑞舒伐他汀联合依折麦布可改善最大剂量他汀类药物单药治疗无法达到目标的高危患者的管理。(c)2007年爱思唯尔公司All rights reserved.
Patients at risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) cholesterol goals on statin monotherapy. This study was designed to investigate the efficacy and safety of rostivastatin 40 mg alone or in combination with ezetimibe 10 mg in patients at high risk of coronary heart disease. Four hundred sixty-nine patients were randomly assigned to rostivastatin alone or in combination with ezetimibe for 6 weeks. The primary end point was the percentage of patients achieving the Adult Treatment Panel III (ATP III) LDL cholesterol goal (< 100 mg/dl) at week 6. Secondary end points included the percentage of patients achieving other ATP III and 2003 European lipid goals, changes from baseline in lipid, lipoprotein, and inflammatory parameters, and safety and tolerability. Significantly more patients receiving rosuvastatin/ezetimibe than rostivastatin alone achieved their ATP III LDL cholesterol goal (< 100 mg/dI, 94.0% vs 79.1%, p < 0.001) and the optional LDL cholesterol goal (< 70 mg/dl) for very high-risk patients (79.6% vs 35.0%, p < 0.001). The combination of rosuvastatin/ezetimibe reduced LDL cholesterol significantly more than rosuvastatin (-69.8% vs -57.1%, p < 0.001). Other components of the lipid/lipoprotein profile were also significantly (p < 0.001) improved with rosuvastatin/ezetimibe. Both treatments generally were well tolerated. Rosuvastatin 40 mg was effective at improving the atherogenic lipid profile in this high-risk population. Combination rosuvastatin with ezetimibe 10 mg enabled greater decreases in LDL cholesterol and allowed more patients to achieve LDL cholesterol goals. In conclusion, rosuvastatin plus ezetimibe may improve the management of high-risk patients who cannot achieve goal on maximal statin monotherapy. (c) 2007 Elsevier Inc. All rights reserved.