<International Circulation>:  Was the effect dose dependent?

   《国际循环》：这些效应是剂量依赖性的吗？
 
    Prof. Nissen:  There were dose dependent increases.  There was a 50% increase of HDL at a 30mg dose， about 90-95% at a 100mg， and 128.8% with the 500mg dose.  

    Nissen教授：存在剂量依赖性增加。30mg剂量时，HDL增加50％，100mg剂量时HDL增加 约90%-95％，500 mg时增加128.8％。
 
    <International Circulation>:  How long would you say we are from getting this into clinical practice?

   《国际循环》：您认为它要多久才可以应用于临床？
 
    Prof. Nissen: It is going to take a few years to get the phase III study done.  If it is successful and we won’t know until we actually conduct the study what could happen.  This is an opportunity we haven’t seen before for drugs that produce enormous increases in HDL levels.  The manuscripts are published simultaneously in JAMA on Tuesday morning.  

    Nissen教授：如果成功的话，完成第三阶段的研究需要几年的时间。在我们实际开展研究 前，我们无法得知。在这之前，我们从未见过有药物能如此大幅度的升高HDL水平。文章在周二上午同步发表在JAMA。
 
    <International Circulation>:  Do you see any more foreseeable hurdles in getting this out?  You mentioned the phase III study needing to be successful， but is there anything else that may influence this?

   《国际循环》：在得到最后的结果方面，您能预测到哪些障碍？您提到如果第三阶段研究成功的话，还有哪些因素会影响研究是否成功吗？
 
    Prof. Nissen: It may not work.  It may raise HDL levels but may not reduce morbidity and mortality.  Until we find the answer to that in a randomized clinical trial we don’t have any answer.  The FDA requires that we show this in a clinical outcome trial and we will do so as quickly as we can.

    Nissen教授：也许不会成功。药物也许可以提高HDL水平但也可能不会降低死亡率和发病率。在我们进行随机临床试验得到数据前，我们也无法预测。FDA要求我们提供临床结果，我们会尽快进行临床试验。

上一页  [1]  [2]