<International Circulation>: What is the evidence for dronedarone， which has been developed for treatment of atrial fibrillation (AF) or atrial flutter (AFL)， maintaining sinus rhythm and reducing stroke in patients with AF?

　　《国际循环》：决奈达隆已用于房颤或房扑的治疗，其恢复窦性心律和减少脑卒中发生的证据是什么？
　　Dr Reddy: There are a couple of pieces of data that are worth looking at. The first study was published by Bramah Singh in the New England Journal of Medicine for the two trials， EURIDIS and ADONIS. EURIDIS was conducted mainly in Europe and ADONIS conducted mainly in the Americas. These were placebo-controlled randomized double-blind studies comparing dronedarone to placebo in patients with atrial fibrillation looking at recurrence and it was clear that dronedarone is better than placebo. The magnitude of benefit， at least in EURIDIS and ADONIS， while it was clear there was benefit， was not that striking. The benefit was a little more striking when we look at ATHENA. ATHENA was a large， again placebo-controlled study and one of the secondary endpoints of ATHENA was time to first recurrence and again what we saw was that dronedarone is better than placebo in terms of maintaining sinus rhythm. The magnitude of benefit is not what we have seen with amiodarone for example. In fact， there is another study called DIONYSOS which was published earlier this year showing that when you compared amiodarone to dronedarone， dronedarone does not perform as well as amiodarone in preventing AF recurrences. The fundamental conclusion is that dronedarone does work better than placebo but not as well as amiodarone. This result was somewhat expected. After we saw the EURIDIS/ADONIS data， we knew that dronedarone， although clearly better than placebo， was not providing the magnitude of benefit we had seen with amiodarone so it was not terribly surprising in DIONYSOS that dronedarone was not as effective as amiodarone. Now it should be said， and one of the very important points and one of the ways that we decide how to treat patients with anti-arrhythmic drugs， is based on the safety of the drug. It is important that all of these studies have shown that dronedarone has a very good safety profile. Essentially it has a very low chance of any of the dangerous complications that can occur with drugs such as amiodarone and even the other class III and class I drugs.

　　Reddy教授：这里有很多值得一看的证据。首先是由Bramah Singh发表在《新英格兰医学杂志》上的二个试验结果，即，EURIDIS 和ADONIS。EURIDIS 是在欧洲完成的，ADONIS是在美国完成的。它们均为随机、双盲、安慰剂对照研究，观察决奈达隆治疗房颤患者的复发率，很明显，决奈达隆优于安慰剂。尽管这二个试验中决奈达隆的治疗获益是明确的，但获益程度还不突出。ATHENA的研究结果进一步凸显了上述治疗获益。ATHENA研究是一个大型的安慰剂对照研究，二级终点之一为首次复发时间，在这个研究中我们再次看到决奈达隆维持窦性心律的效果要优于安慰剂。这种获益程度与胺碘酮获益不同，比如，还有一个今年早些时候发表的叫 DIONYSOS的研究，比较的是胺碘酮和决奈达隆，结果发现，决奈达隆在预防房颤复发方面并不优于胺碘酮。基本结论是决奈达隆优于对照，但并不优于胺碘酮。这样的结果是可以预料的。在EURIDIS/ADONIS数据发表后，我才知道决奈达隆提供的获益与胺碘酮是不同的，因此，在DIONYSOS中看到决奈达隆与胺碘酮的有效性不同就没什么值得惊讶了。决定如何使用抗心律失常药治疗很重要的一点就是考虑该药物的安全性。迄今所有的研究均表明，决奈达隆安全性非常好。实际上，采用胺碘酮甚至其他Ⅲ类或Ⅰ类抗心律失常药也有非常低的危险并发症的发生率。