<International Circulation>: The results of the TRILOGY trial were released yesterday. Could you please give us your thoughts on the trial? What are some its strengths?
《国际循环》:昨天公布了TRILOGY试验的结果。你如何看待该试验?该试验的优点是什么?
Dr. Neumann: The good part is that it addresses a patient population that has thus far been understudied. It is a large trial with clear cut results. It is a negative study, as prasugrel turned out to be no more efficient than clopidogrel.
Neumann博士:该试验的优点是纳入了以往研究不足的患者群。另外样本量大,结果明确。但是,TRILOGY试验得出了阴性结果,普拉格雷不比氯吡格雷更为有效。
<International Circulation>:The data showed no difference in the primary end points, but a trend favored prasugrel after one year. Is there any clinical significance to this finding?
《国际循环》:数据显示,普拉格雷和氯吡格雷组的主要终点无差异,但是1年后有普拉格雷比氯吡格雷益处更大的优势。这一发现的临床意义什么?
Dr. Neumann: I think it is always difficult to interpret trial with a negative primary end point. There is always a tendency to look at sub-groups and sub-analyses to find some efficacy there. But this is just hypothesis generating. While it is an interesting finding, it needs to be shown whether this is a play of chance or a true finding that can be repeated in subsequent studies. Given that the overall primary endpoint was clearly negative, and given that there was only a weak interaction between the drug effect and the two study periods , I do not think we should make too much of it.
Neumann博士:我认为,解释主要终点得出阴性结果的研究通常是困难的。一直有一种趋势去观察亚组和进行亚分析来发现一些疗效更好的证据。但是,此种分析只是用于产生假设的。当然得出了有趣的发现,但是需要证实该发现是偶然的发现还是真正的结果,可在随后的研究中重复该结果。鉴于主要终点总体上显然是阴性的,同时药物治疗的效果和两个观察时期之间只有较弱的相互作用,我认为不应当对此过度解释。