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Pr Giancarlo Agnelli: Recurrent venous Thromboembolism

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MD-FM INSIGHT Tuesday 18 June 2013  


Hello! You’re on MD-FM INSIGHT, the first medical web radio.

Clementine: Today we’re pleased to offer you a "Question & Answer" program devoted to the prevention of recurrent venous thromboembolism

At the 2012 meeting of the American Society of Hematology, which took place in December in Orlando Florida, new data were presented to help guide physicians who are uncertain about whether they should extend or stop standard anticoagulation therapy when recurrent events are absent in VTE patients. We sat down with the senior author of the AMPLIFY-EXT trial, testing the use of the new agent Apixaban in this context. Pr. Giancarlo Agnelli, from the University of Perugia in Italy, led us through the details of his study.


So Dr. Agnelli, tell us: what were you trying to find out with the AMPLIFY-EXT trial?


In this study we tested the possibility of extending treatment of patients with venous thromboembolism. In other words, all the patients we included in the study had already received the proper anticoagulation for 6 to 12 months, and then we randomized these patients to placebo or to two doses of apixaban. We really wanted to see if extending treatment was effective and safe.


Yes because we know that stopping warfarin increases the risk of recurrent VTE by up to 10% in patients without reversible risk factors. But some studies have tested extending the use of warfarin?


Yes. Similar studies were done with warfarin and the idea was to reduce the intensity of anticoagulation in patients receiving warfarin and to achieve some benefit. But unfortunately when warfarin was used, the efficacy was reduced and there was no advantage in terms of bleeding. So by using traditional agents, this idea of making treatment easier actually failed. And this is why we are exploring different possibilities 


Ok so Apixaban is a recently approved factor-Xa inhibitor, just like rivaroxaban. Another anticoagulant also available is dabigatran, a direct thrombin inhibitor. These drugs have also been tested haven’t they?


There are some studies with dabigatran and rivaroxaban, they were also successful, we don’t have any way to compare this new agent apixaban with the others because we don’t have head to head comparison 


So what did you find in your study?


We found that by giving apixaban at two doses, we were able to reduce by 80% the risk of recurrence and VTE-related mortality. So it’s quite clear that when you stop warfarin, you have a high recurrence rate, and this high recurrence rate was reduced by 80% with apixaban. And what is even more important is that the price we had to pay is actually very low because usually, bleeding is associated with an anti-thrombotic agent, but this was not the case because the rate of major bleeding was very much the same for apixaban, an active agent, and placebo. So we showed that both doses are effective and the lower dose was effective and safe, so it really opens the way to making treatment easier. 


So in your opinion, what are the advantages of going for this oral anti-coagulant compared to warfarin?


You don’t need monitoring. You might know that when you use warfarin, you don’t have a clear response between the dose and the effect, so you need to adjust the dose by making blood tests. Actually patients need to have their blood tested every 2 to 3 weeks, and the dose adjusted. By using these new agents, and apixaban in particular, you can use a fixed dose, in this particular case 5 mg twice a day or 2.5 mg twice a day, without any monitoring. So you don’t need to check your blood, you don’t need to adjust your dose, you have a fixed dose and you can keep going for months. 


What would you recommend to doctors?


I think the main message is that now we can prolong treatment, in an easy way, without creating problems for the patients –I mean no monitoring –it’s very effective at reduce the recurrence and this can be done safely. So we really have a new important strategy to extend treatment and to prevent recurrences of this severe disease. 


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