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[ADA2012]吡格列酮治疗糖尿病的风险与获益
——Steven E.Nissen教授专访
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作者:S.E.Nissen 2012/6/12 11:02:00    加入收藏
内容概要:Nissen教授:我认为,合适的患者应用吡格列酮有良好的获益风险比。我这么说是基于下述事实,即虽然大家已经知道了吡格列酮的风险,但是某些患者应用吡格列酮风险要小。例如,应用吡格列酮有发生充血性心衰的风险,但是如果避免在低射血分数的患者应用吡格列酮的话,就可以避免这一风险。

  Steven Nissen ACC前任主席,美国克利夫兰临床中心 心血管医学部主任

  <International Diabetes>: How do you evaluate the risk efficacy ratio of pioglitazone?
  Prof. Nissen:  In my opinion, pioglitazone in the right patient still has a favorable benefit to risk ratio. I base that on the fact that its risks are well known and in a number of cases can be mitigated. For example, there is a risk of congestive heart failure but if you avoid giving the drug to patients with a low ejection fraction you can avoid that risk. There is a risk of fractures but you try to avoid giving the drug to elderly females for example who are at high risk for osteoporosis. To balance that out, we have a constellation of studies which when looked at together as we did in a meta-analysis, show a reduction in cardiovascular morbidity and mortality which are the things that are most likely to cost diabetics their lives or to produce unacceptable morbidity. So I will trade those nuisance adverse effects (although they are not to be taken lightly) for the cardiovascular benefit any day and that is why I think the drug still belongs in the armamentarium.

  《国际糖尿病》:你如何评价吡格列酮的获益风险比?
  Nissen教授:我认为,合适的患者应用吡格列酮有良好的获益风险比。我这么说是基于下述事实,即虽然大家已经知道了吡格列酮的风险,但是某些患者应用吡格列酮风险要小。例如,应用吡格列酮有发生充血性心衰的风险,但是如果避免在低射血分数的患者应用吡格列酮,就可以避免这一风险。吡格列酮也有引起骨折的风险,但是如果避免在老年女性中应用吡格列酮,就可以避免这一风险(因为老年女性发生骨质疏松的风险高)。为了观察上述风险之外吡格列酮的相对益处,我们对一系列研究展开了荟萃分析,结果显示吡格列酮能够减少心血管疾病和死亡,这才是最有可能夺去糖尿病患者生命或带来难以接受的疾病的事情。所以,为了每天给患者带来心血管益处,我愿意承受吡格列酮的不良反应(当然我们对不良反应也不能掉以轻心)。正是基于上述原因,我认为吡格列酮仍是糖尿病治疗药物的一员。

  <International Diabetes>: One adverse effect that is a hot topic concerning pioglitazone is bladder cancer. Can you address that issue?
  Prof. Nissen: I am just not convinced that there is an effect. The studies that have led to this conclusion are weak and inconclusive and some of them actually go in different directions. Out just today is a long-term analysis from the Kaiser Permanente System that shows a hazard ratio for bladder cancer of 0.98, which essentially is neutral. I think the jury is still out on bladder cancer. If it does occur it occurs at such a low rate as to not be a very significant concern in relation to the cardiovascular benefit.

  《国际糖尿病》:有关吡格列酮的不良反应,大家比较关注的是膀胱癌。你怎么看?
  Nissen教授:我不能确定吡格列酮是否会引起膀胱癌。得出这一结论的几项研究统计学效力弱,结论是不确定的。实际上,其中一些研究得出的结论并不一致。今天在ADA年会上公布了Kaiser数据的长期分析结果,结果显示,膀胱癌的发生风险比是0.98,这基本上是一个中性结果。我认为,膀胱癌的问题还没有定论。即便吡格列酮真的会引起膀胱癌,其发生率也是很低的,与吡格列酮的心血管益处相比,算不上什么大问题。

  <International Diabetes>:What is your opinion about the durability of pioglitazone?
  Prof. Nissen:  All of the drugs in the TZD class including pioglitazone have the greatest durability of glucose lowering effect of anything we have had yet. Patients continue to respond well to the drug in terms of blood sugar lowering for many years. We have studies out to five years. Many people with clinical experience with the drugs tell me that it goes on well beyond five years. We don’t have anything else that has that durability of proven glucose lowering long-term benefit.

  《国际糖尿病》:你怎么看吡格列酮的持久降糖作用?
  Nissen教授:在当前所有种类的降糖药物中,TZD类药物的降糖作用是最持久的,吡格列酮也是如此。患者应用吡格列酮后很多年血糖都控制得很好。我们最长研究了5年。很多有吡格列酮应用经验的患者告诉我,用药超过5年时效果还很不错。除了吡格列酮之外,目前还没有其他药物被证实降糖作用可以维持这么久。

  <International Diabetes>:Should rosiglitazone and pioglitazone be considered the same drug when it comes to cardiovascular effects?
  Prof. Nissen:  I think they are not. In our analyses published in the Archives of Internal Medicine and the New England Journal and JAMA, we have shown that the two drugs have a completely different pattern of cardiovascular outcomes. Pioglitazone can still reduce adverse cardiovascular outcomes and rosiglitazone can still increase them. That has led of course to the withdrawal of rosiglitazone. I think the agency made the right decision in terms of restricting the drug although I would have gone further and just removed it from the market. These drugs do not appear to be similar and in fact what I have said in the discussion today here at ADA, is that they are not really even in the same class. There is no class here. Each of these drugs needs to be considered individually.

  《国际糖尿病》:罗格列酮和吡格列酮的心血管效应是否相同?
  Nissen教授:我认为两者并不相同。我们在《内科学文献》(Archives of Internal Medicine)、《新英格兰医学杂志》和JAMA发表的文章中指出,罗格列酮和吡格列酮治疗的心血管转归完全不同。吡格列酮会减少心血管事件发生,而罗格列酮增加心血管事件风险。当然,这导致了罗格列酮的退市。我认为,美国FDA作出了正确的决定,即限制罗格列酮的销售。尽管我本人希望能够更近一步,就是让罗格列酮退市。罗格列酮和吡格列酮并不一样,事实上在今天ADA年会的讨论上,我提到两者甚至不属于一类药物。根本没有类别这回事儿。我们应当区别对待罗格列酮和吡格列酮。
  <International Diabetes>: When monotherapy with metformin is not enough, often the physician will turn to a second drug to balance out the HbA1c. What is your opinion on combining pioglitazone with metformin?
  Prof. Nissen:  We certainly do it and I think many diabetologists do it, but not in every patient because as we have said it is not the right drug for everybody. But it is a good drug which belongs in the armamentarium and when used judiciously in the right patients it will have a very beneficial effect on blood sugar and cardiovascular outcomes. Sometimes we will add it as a second drug and sometimes we might add it as a third drug. We see patients who might get metformin and then either a sulfonylurea which they no longer respond to, or a DPP-4 inhibitor, and then add pioglitazone as a third drug.

  《国际糖尿病》:当二甲双胍单药治疗血糖控制不好时,医生通常联用另一种药物,以使HbA1c达标。你怎么看吡格列酮与二甲双胍联用?
  Nissen教授:我们确实会这么用药,我想很多糖尿病医生也会这么做,但是并不是每个患者都会这样。因为正如我前面所说的,吡格列酮并不适合每一个糖尿病患者。但是,吡格列酮是一个好的糖尿病治疗药物。如果在合适的患者中正确应用吡格列酮的话,会对血糖和心血管转归发挥有益的作用。有些时候,我们会在单个药物或两个药物的基础上联合吡格列酮。当看到一些患者可能应用二甲双胍血糖控制不好,之后联合了磺脲类药物或DPP-4抑制剂仍然控制不好时,我们就会给患者加用吡格列酮。

  <International Diabetes>: Dr DeFronzo said today in your discussion, you could use it as a first drug. What do you think about that?
  Prof. Nissen: It is an interesting idea. I have not personally done that but it is not a crazy idea. Dr DeFronzo is a tremendous authority on diabetes and has been right about a lot of things over the years and we ought to listen to him.

  《国际糖尿病》:在今天的讨论中,DeFronzo博士提出将吡格列酮作为一线治疗药物

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