Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study)
Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study)
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DOI：
10.1016/j.amjcard.2008.02.092
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发表时间：
2008-05-15
影响因子：
2.8
通讯作者：
Karas, Richard H.
中科院分区：
文献类型：
--
作者：
Ballantyne, Christie M.;Davidson, Michael H.;Karas, Richard H.
将专利烟酸缓释剂加辛伐他汀(NER/S；1,000/20和2,000/20毫克/天)与单一辛伐他汀(20毫克/天)治疗24周的2种方案的有效性和安全性进行了比较，研究对象是319名以混合型血脂异常为主的高危患者，这些患者已经进入了国家胆固醇教育计划成人治疗小组III的低密度脂蛋白胆固醇风险调整目标。辛伐他汀20 mg/d磨合后，两种剂量(1,000/20和2,000/20 mg/d)的NER/S与辛伐他汀20 mg/d相比，非高密度脂蛋白胆固醇的降幅更大(分别为-13.9%和-215%比-7.4%；p=200 mg/dl)通常对NER/S的血脂反应更大，但值得注意的是，无论是否有甘油三酯升高的人，高密度脂蛋白胆固醇对NER/S的反应相似。两个剂量的NER/S治疗耐受性良好，90%的患者潮红强度为轻或中度，两个剂量的NER/S治疗组只有7.5%的患者因潮红而停止治疗。NER/S的安全性与每个部件的安全性曲线一致。总之，这项研究表明，NER/S在多个血脂参数方面提供了额外的临床相关改善，并且是安全的和良好的耐受性。(C)2008 Elsevier Inc.保留所有权利。
The efficacy and safety of 2 regimens of a combination of a proprietary niacin extended release plus simvastatin (NER/S; 1,000/20 and 2,000/20 mg/day) were compared with simvastatin monotherapy (20 mg/day) for 24 weeks in 319 high-risk patients with predominantly mixed dyslipidemia who were already at National Cholesterol Education Program Adult Treatment Panel III risk-adjusted goals for low-density lipoprotein cholesterol. After a run-in on simvastatin 20 mg/day, both NER/S doses (1,000/20 and 2,000/20 mg/day) resulted in greater decreases in non-high-density lipoprotein (HDL) cholesterol vs simvastatin 20 mg/day (-13.9% and -215% vs -7.4%, respectively; p = 200 mg/dl) typically had greater lipid responses to NER/S with the notable exception that HDL cholesterol responses to NER/S were similar in those with or without increased triglycerides. Treatment with both doses of NER/S was well tolerated; 90% of flushing was mild or moderate in intensity, and only 7.5% of patients in both NER/S treatment groups discontinued because of flushing. The safety of NER/S was consistent with the safety profile of each individual component. In conclusion, this study showed that NER/S provided additional clinically relevant improvements in multiple lipid parameters and was safe and well tolerated. (C) 2008 Elsevier Inc. All rights reserved.