1. 如我们所知,JIKEI Heart Study和KYOTO Heart Study两个研究都是在日本进行的,而且您都有参与,请问这两个研究有什么联系和区别吗,比如入组人群、试验程序、终点选择,尤其是结果上?这些结果有什么启示作用呢?2. 随着亚洲生活方式的日益西化,代谢综合征的发生也日益增加,KHS研究特别纳入了代谢综合征患者,您认为对于合并代谢综合征的患者,用药方面有什么特别之处,缬沙坦在这方面有何优势?
International Circulation: Both JIKEI HEART study and KYOTO HEART study were carried out in Japan and you were involved in both studies. Could you talk about the similarities and differences of the two trials in terms of the patient population, study procedures, and especially the outcomes? What can we learn from that outcome?.
《国际循环》:JIKEI HEART研究和KYOTO HEART研究均在日本进行,而且您参加了这两项研究。能否请您谈一谈两项试验的异同之处,比如患者人群、研究程序、以及其他方面,特别是结果?
Dahlof: I think the similarities are that they both test strategies to improve blood pressure control by using an ARB like valsartan in this case and in high risk populations to compare them witb the strategy of giving anything else. You can say it is a mixture of all the other drugs available except you can not use an ARB. So there are many similarities between the two trials. Then you can also say that they were different because JIKEI HEART study had a population that had more medication than KYOTO HEART study. I think the average numbers of drugs from the beginning in JIKEI was about two while it was more like one drug in KYOTO HEART trial. You can say that the patients were a little bit more severe in terms of hypertension in JIKEI HEART study. I don’t think that matters so much. They were both at high risk and were both experiencing roughly the same benefits. So I think that if you want to say something about what is the importance about KYOTO HEART study, it is that we really confirm what we have seen in the JIKEI HEART. So they are both complimentary, giving a very similar message. I think that the main outcomes of the two being very strong on stroke and angina showing so much similarities tells us that it is a solid outcome of adding valsartan to other therapies. I think that the comments today at the hotline session were really not so fair. Someone said that angina was not really important because it was not an MI. I do not think that the effect on MI is anything unique for any of these trials. It has happened in all ARB studies. But the angina effects are quite unique. You have not seen so much angina effects in other trials. That could be something more pronouncing in Japanese population. It has to be confirmed in maybe some other ways why that is. But I can tell you that the result about angina from both studies is solid because they are talking about hospitalizations for angina and patients who were subject to angiography.
Prof. Dahlof:两个研究都通过应用一种血管紧张素受体阻断剂(ARB),如本例中的缬沙坦,来验证改善血压控制的策略,并且通过应用于高危人群与其他药物进行比较。所以这两项试验之间有着许多相似之处。但是它们之间也存在不同之处:第一,JIKEI HEART研究的人群比KYOTO HEART研究使用了更多药物。JIKEI HEART研究起始平均用药数量约为两种药物,而在KYOTO HEART研究中较多可能为一种药物。第二,JIKEI HEART研究中的入组人群在高血压病情上略为严重。但由于两个研究的入组人群均为高危人群,他们都有着几乎相同的获益,所以不会产生很大的影响。
所以,KYOTO HEART研究的重要性在于:证实了我们在JIKEI HEART研究中的结果。也就是说,这两个研究是互补的,他们传递着相似的信息。而且两个研究的主要结果都集中在卒中和心绞痛方面,这告诉我们:在常规治疗的基础上假如缬沙坦后,临床预后有很大的改善。
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