<International Circulation>: In the TRITON trial there was a higher bleeding risk with prasugrel but in the TRILOGY trial they actually had similar safety endpoints.  Could you explain some of the reasons for this?
《国际循环》：在TRITON试验中，普拉格雷组的出血发生率高于氯吡格雷组，但是在TRILOGY试验中，普拉格雷和氯吡格雷安全终点的发生率相似。你能否解释下出现此种结果的原因？
Dr. Roe: We think that reduction prasugrel dosage to 5mg for low body weight and elderly patients had a lot to do with that.  In this study， we did show that there was a slight increase in major bleeding with prasugrel， but it was not significant.  We did not see an increase in fatal or life-threatening or intracranial bleeding.  Those are the ones we really want to avoid and did avoid in comparison with clopidogrel. The results speak for themselves， and a reduced dose is indicated for vulnerable patients.  As this was a longer study than the TRITON trial， we can say that when we adjust the dose for key characteristics， it is safer. This should provide a lesson for future studies: one dose of an antiplatelet drug， or perhaps even an anticoagulant drug， does not fit all patients. We need to do a better job of individualizing.
　MT Roe博士：我认为，这一结果主要是与低体重患者和老年患者应用普拉格雷的剂量降低至5 mg有关。在TRILOGY试验中，我们发现普拉格雷能够轻度增加严重出血的风险，但是差异未达到统计学显著意义。未发现致死性出血、危及生命的出血或颅内出血发生率增加。这些是我们真正想要避免的并发症，在跟氯吡格雷的比较中也确实证明发生率没有增加。结果证明了一切，低体重患者和老年患者应降低普拉格雷的剂量。由于TRILGOGY试验的随访时间比TRITON试验长，因此可以说针对主要临床特征调整普拉格雷的剂量之后，普拉格雷的确更为安全。这为未来的研究带来了启示：单一剂量的抗凝药物，或抗血小板药物不能适用于所有患者。我们需要做的更好，进行个体化的治疗。
<International Circulation> : In the TRILOGY trial， you had fewer recurrent total ischemic events.  When you combine the results from the TRITON trial what would be your recommendation of the choice of DAPT in ACS patients?
《国际循环》：在TRILOGY试验中，总体缺血事件的发生率低。结合TRITON试验的结果，你对ACS患者双联抗血小板治疗有哪些建议？
Dr. Roe: Our results do not change the TRITON results， they stand alone.  We cannot recommend， based on our results， the use prasugrel over clopidogrel in medically managed patients. We think it is similar in the first year and perhaps different after that， but I do not think the guidelines will change based on our study.  I think long term treatment is safe and I think physicians are going to have to judge the results of our trial. Are they going to want to treat someone for this long period of time to see a delayed effect? or would they prefer to use the standard comparator? That is their choice， but I think we should interpret our results in the way that they are. You should not change opinions of the TRITON trial based on our study， other than the fact that by reducing the dose in the vulnerable patients， you can improve safety. The patient groups who received the new dosage were of some concern in the TRITON results. Before TRILOGY， people have been reluctant to use prasugrel in those groups， but y reducing the dose we have hopefully changed that thinking.
MT Roe博士：TRILOGY试验的结果并非与TRITON试验不一致，两者是独立的。我们不能依据TRILOGY试验推荐在单纯药物治疗的ACS患者优先选择普拉格雷而不是氯吡格雷。我认为，1年随访内普拉格雷和氯吡格雷治疗患者的转归是相似的，之后可能有些不同，但是我不认为TRILOGY会影响指南，使其作出更新。我认为，普拉格雷长期应用是安全的，医生也开始探讨TRILGOY试验的结果。他们是否想要治疗患者这么长时间以看到延迟的效应？或者他们还是倾向于应用标准的对照药物？选择权在他们自己手中。但是，我认为我们应当实事求是地解读TRILOGY试验的结果。不能依据TRILOGY试验的结果来改变TRITON试验所得出的结论，只不过是通过降低普拉格雷的剂量，可以改善普拉格雷治疗的安全性。对于TRILOGY试验中应用较低剂量普拉格雷这样的患者，在TRITON试验中对其是由一些担忧的。在TRILOGY试验开展之前，大家不愿意在这样的患者中应用普拉格雷，但是通过降低普拉格雷的剂量，我们期望能够改变大家旧有的看法。

上一页  [1]  [2]  [3]  [4]  下一页