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[AHA2011]Steven Nissen 教授谈CETP 抑制剂最新研究进展
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作者:StevenE.Nissen 编辑:国际循环网 时间:2011/11/21 16:31:00 关键字:CETP抑制剂 他汀 HDL-C  Steven E. Nissen 

    Steven Nissen   美国克利夫兰临床中心心血管医学部
    <International Circulation>:  You mentioned a CETP inhibitor in trials, can you tell us more about that?

   《国际循环》:您在临床研究中提到过CETP抑制剂,你可以详细的介绍下吗?
 
    Prof. Nissen:  It was a global study of patients treated with statins, although a group of them was treated with monotherapy, with a goal being to find what the lipid effects would be from a CETP inhibitor.  In the monotherapy trial we studied three doses, 30mg, 100mg, and 500mg.  In the highest dose HDL increased 128.8%, an amazing increase.  In the same group LDL fell by 35.9%.  That is large decrease in LDL and a huge increase in HDL.  When we gave the drug with statins we used the 100mg dose and saw all the effects in monotherapy but on top of the statin effects.  Most of those patients in the statin trial had HDL levels substantially higher than their LDL levels, with many having HDL levels over 100.  We though the data was very promising, with none of the safety issues that had arisen during the development of torceptrapib, so we think that the data support could move this very quickly into a phase III mortality and morbidity trial.  There were not intolerance issues, no apparent side effects, and blood pressure did not increase.  We really saw no dangerous side effects whatsoever.  

    Nissen教授:这是一个全球研究,研究人群为他汀类药物治疗的患者,虽然其中一组是单药治疗,目的是确定CETP抑制剂对血脂的影响。在单一疗法研究中,我们研究了三种剂量,30mg,100mg和500mg。在最高剂量时,高密度脂蛋白胆固醇(HDL)增加128.8%,增长是惊人的。在同一组中,低密度脂蛋白(LDL)下降了35.9%。HDL增加的幅度和LDL降低的幅度都是很大的。当我们给予他汀类药物时,剂量为100mg,看到所有单药治疗的疗效但在他汀类药物疗效之上。他汀类药物试验中的大部分病人HDL水平显著高于LDL水平,许多人HDL水平超过100。我们认为数据是非常令人鼓舞的,在torceptrapib开发过程中没有出现安全问题,所以我们认为可以进入到III阶段死亡率和发病率试验。在试验中没有出现不耐受问题,没有明显的副作用,血压没有升高。我们确实在任何受试者身上都没有观察到任何危险的副作用。
 



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