International Diabetes: The RECORD study proved rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compred with standard glucose lowering drugs. What is your opinion about these results?
《国际糖尿病》：RECORD研究证明与标准降糖药治疗相比，罗格列酮没有增加整体心血管病发病和死亡的风险。您对上述结果的观点如何？
Prof. Beck-Nielsen: I expected that result because there have been so many previous studies showing that glitazone has an overall beneficial cardiovascular profile. However， you can create heart failure and we were cautious about including heart failure as an endpoint. I expect that he beneficial effect in time will be much more pronounced. If you look at the UKPDS study， you can see that you need years before you can see a beneficial effect on the cardiovascular system.
Beck-Nielsen教授: 该结果在我的意料之中，因为此前有很多研究显示格列酮类药物对心血管因素的整体益处。但是可能导致心衰，所以我们对心衰终点持谨慎态度。我认为随着时间的推移它的益处将会显示得更清楚，我们看UKPDS研究就知道，降糖治疗对心血管系统的好处要等到多年后才能显现。
International Diabetes: The rosiglitazone group was superior to metformin and sulfonylurea group in myocardial infarction and stroke but it did not reach statistical significance. What is your opinion of that result?
《国际糖尿病》：罗格列酮组对心肌梗死和卒中的益处优于二甲双胍联合磺脲治疗组，但差异没有达到统计学意义。您对此的观点是什么？
Prof. Beck-Nielsen: That is because there were not very many strokes and myocardial infarctions in the study period. If you look at the study the number of events is low and that has been used as an argument against the RECORD study but I think that it is a very positive thing that you see so few cardiovascular events in well treated T2D patients. If you use rosiglitazone in combination with statins and antihypertensive drugs you can have event rates very close to the background population. The risk of a cardiovascular event in diabetics is presently only twice that of the background population. The prognosis is very good and therefore it is very difficult to get statistically significant differences. Based on a metanalysis of all the studies with rosiglitazone a statistically significant reduction in the number of strokes was found. Therefore， it reduces the risk of strokes.
Beck-Nielsen教授:其原因是该研究中心肌梗死和卒中事件发生率较低，可以看到研究中观察到的事件数量很少，这也是RECORD研究引起争论的一个原因，但在经很好治疗的2型糖尿病患者中观察到如此少的心血管事件，我认为很正常。如果罗格列酮联合他汀和降压药治疗，那么事件发生率就很接近于正常人群，况且糖尿病患者的心血管事件风险也仅为正常人群的2倍，因此很难得到有统计学差异。所有有关罗格列酮研究的荟萃分析均提示，罗格列酮可显著减少卒中事件，有统计学差异。因此我认为罗格列酮可以降低卒中风险。
International Diabetes: Rosiglitazone use doubles the risk of fracture in female patients. What is the clinical significance?
《国际糖尿病》：RECORD研究中显示罗格列酮的使用使女性骨折的风险加倍，其临床意义是什么？
Prof. Beck-Nielsen: That is what worries me the most. It is more problematic with fractures because when you see the problem there are already bone changes and it is not easy to reverse. Currently we do not know if we can pick out the group with the higest risk. It may be possible if we look into the data carefully. Perhaps we can also prevent it. It is not only rosiglitazone but also pioglitazone that have this fracture risk.
Beck-Nielsen教授: 这是我最担心的问题。因为当医生注意到这个问题时，骨骼已经发生改变了，而且一旦改变很难恢复。如果进一步分析研究数据，我们或许可以识别出骨折的高危患者，从而预防骨折的发生。不仅是罗格列酮，吡格列酮也同样存在骨折风险。
International Diabetes: Is there a message that you would like people to take from the RECORD study? How do you plan to follow up on the RECORD study?
《国际糖尿病》：您希望人们从RECORD研究中得到什么样的信息？您计划对RECORD研究如何做后续的随访？
Prof. Beck-Nielsen:The major message is that the risk with using rosiglitazone in combination treatment in T2DM in respect to cardiovascular disease is exactly the same as if you use metformin. It is also important that glucose values are significantly reduced with rosiglitazone， and in fact we can not normalize glucose values in diabetics without improving insulin action and the only drugs that can improve insulin action are the glitazones. If you follow these patients for ten years I believe you will see a significant reduction in microvascular complications too. When you treat T2DM patients so well with statins and antihypertensive drugs， the cardiovascular problem in the future will be very low and the real risk for these patients will be microvascular complications， and specifically kidney problems.
Beck-Nielsen教授:最主要的信息是在2型糖尿病的药物治疗中使用罗格列酮与二甲双胍对心血管的影响结果相同；另外就是罗格列酮组血糖水平显著下降，实际上在不改善胰岛素敏感性的情况下，很难使血糖恢复正常，格列酮类药物是惟一可显著改善胰岛敏感性的药物。如果随访10年，我相信患者的微血管并发症也将显著减少。2型糖尿病患者如能得到很好的他汀和降压药物治疗，心血管病变的发生率将会很低，因此微血管并发症才是未来糖尿病患者的真正威胁，特别肾脏病变。