International Diabetes:  The main purpose of the RECORD study is to evaluate the cardiovascular safety of rosiglitazone. How do you feel about the cardiovascular safety of rosiglitazone and what is the clinical significance of the RECORD study?

《国际糖尿病》：RECORD研究的主要目的是评价罗格列酮的心血管安全性，请您谈一下RECORD研究的临床意义？关于罗格列酮的心血管安全性您如何看待？

Prof Hanefeld: The answer is quite clear from RECORD study– there is no concern with respect to long-term safety of rosiglitazone combination.It was a non-inferiority study and there was no indication of increased risk. There was even a clear tendency for a lower cardiovascular mortality rate despite the fact that this study included heart failure as part of the composite endpoint.

Prof Hanefeld教授：RECORD研究的结果非常清楚，没有必要担心罗格列酮的心血管安全性。RECORD研究非劣效性分析显示，罗格列酮不增加心血管相关风险。尽管该试验表明心衰是其复合终点之一，但该研究还是表明罗格列酮不仅不会增加心血管死亡风险，而且还可明显降低其死亡风险。

International Diabetes: Now we have the results of this study， what messages or advice can we give clinical doctors on the use of rosiglitazone?

《国际糖尿病》：根据RECORD研究结果，关于罗格列酮的使用您对临床医生有什么样的建议？

Prof Hanefeld: I think there is no reason for stopping rosiglitazone treatment in patients who are well-treated with rosiglitazone. The clear message for medical doctors now is that we can say we are really on the safe side and this paper from Nissen and Wolski and its short term meta-analysis of adverse events of cardiovascular disease was premature and not valid for a long term outcome of five years for example. This glitazone has a much better long term effect on preventing progression of diabetes. It means the need to introduce insulin treatment as rescue treatment but if you see a rapid rise in HbA1c after one year，as was observed in the UKPDS study. The other beneficial effects are that we see a tendency for a lower incidence rate of micro-angiopathy and particularly we see good benefits for albuminuria. Simply， in many aspects， it is a rehabilitation of rosiglitazone.

Prof Hanefeld教授：我认为对于罗格列酮控制良好的患者不应终止罗格列酮治疗，可以明确地说，罗格列酮的安全性良好。5年以上长期随访证据表明Nissen和Wolski的结论尚不成熟。格列酮类药物在预防糖尿病进展方面的长期效果更好，如果治疗1年后 HbA1c值快速升高，则需要加用胰岛素，正如UKPDS研究所观察到的一样。此外，罗格列酮还可降低微血管病发病率，尤其是改善蛋白尿方面的益处。这将重新奠定罗格列酮在糖尿病治疗中的地位。

International Diabetes: What needs to be done to further this study?

《国际糖尿病》：关于RECORD研究，您认为还需要做哪些方面的进一步研究？

Prof Hanefeld: I would have been happy if we were going to have a ten year follow-up for cardiovascular events.

Prof Hanefeld教授：RECORD研究如果能继续随访10年，将非常令人兴奋。