<International Circulation>:Also， in the TRILOGY trial， 5mg doses of prasgurel are used in elderly and low weight patients. What is the rationale for using lower doses of prasgurel in these patients?
Prof. Montalesco: This is a very important question. When TRITON was performed， the net clinical benefit - the end point mixing ischemic and bleeding events - was neutral in patients with low body weight and in the elderly. This was because of an excess of bleeding. Some PK/PD modeling suggested that the dose should be reduced to 5mg in these patients， but there was no prospective study to validate this suggestion. However， EMEA in New York accepted that modeling and has recommended that dose on the drug label. Now TRILOGY comes with a 5mg dose. We will have clinical data for around 2500 patients and we will see how safe the drug is. Are these drugs good or bad? Safety is going to be better in the elderly with 5mg than with 10mg， but we also have look at efficacy. Another important study will be presented on Tuesday. It is a generations study and a pharmacologic study comparing the elderly to younger patients， again looking at 5mg versus 10mg doses. Both a biological and clinical study will be presented at this meeting.
《国际循环》：在TRILOGY-ACS研究中，老年患者和低体重患者应用的普拉格雷剂量为5 mg/d。这些患者应用低剂量普拉格雷的理论依据是什么？
Montalesco教授：这是一个非常重要的问题。TRITON TIMI-38试验中，低体重和老年患者的净临床获益，即缺血和出血时间的总和是中性的，这主要是由于出血的发生率高。一些药代动力学/药效动力学模型显示，在这些患者普拉格雷的剂量应当减少至5 mg/d，当然还缺乏前瞻性研究来验证5 mg/d这一剂量。但是，欧洲药品管理局（EMEA）接受了上述模型的结果，在普拉格雷的处方信息中批准了5 mg/d这一给药剂量，现在TRILOGY-ACS研究中也包括了5 mg/d的给药剂量。我们将会得到大约2500例患者的临床数据，来观察普拉格雷的安全性。老年患者应用5 mg/d剂量的安全性将优于10 mg/d，但是我们还需要观察有效性终点。在周二有另一项重要研究公布， generations试验，这是一项药效学研究，比较了老年和青年人群5 mg/d和10 mg/d的剂量。因此在本届年会上同时有普拉格雷的药效学研究和临床研究公布。
<International Circulation>:Dose is important， as is platelet function. In this trial， 1/3 of the patients took the platelet function test. What is the object of this sub-study?
Prof. Montalesco: It is an important sub-study because it is in a clinical trial and several thousands of patients have been monitored. It is the largest platelet function study ever done with two active treatments， copidogrel or prasugrel， with prasugrel being used at two different doses， 5mg or 10mg. We will know in terms of platelet function what is really effective， and if prasugrel， even with 5mg， is more effective than clopidogrel. The platelet function study will not be presented here， but will be presented at the American Heart Association.
《国际循环》：剂量很重要。血小板功能也很重要。在TRILOGY-ACS研究中，三分之一的患者接受了血小板功能测定。血小板功能亚组研究的目的是什么？
Montalesco教授：血小板功能亚组研究是一项重要的亚组研究，因为这是在临床试验当中的亚组研究，测定了几千例患者的血小板功能。这是迄今为止开展的两个活性药物对比（普拉格雷对比氯吡格雷）情况下最大规模的血小板功能检测研究，普拉格雷有5 mg/d和10 mg/d两个用药剂量。通过血小板功能检测，我们会知道哪个药物更有效。普拉格雷甚至是在5 mg/d的剂量下是否优于氯吡格雷？我认为血小板功能亚组研究的结果不会在本届ESC年会上公布，而是会在未来的AHA年会上公布 。
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