Only three years ago, our clinical trials center began participating in antithrombotic trials that would have a significant impact for the future treatment for prevention of thromboembolic events in patients with nonvalvular atrial fibrillation.
The first agent to be approved by the FDA as an alternative to warfarin was dabigatran, a direct thrombin inhibitor. Dabigatran (Pradaxa ), approved in Oct. 2010, is taken twice daily but somewhat limited because of gastrointestinal symptoms (GIS). CANH will be starting a trial in Jan. 2012 addressing patients that develop these GI symptoms. They will be randomized into two treatment arms either taking drug with food or adding propranazole to their medication regimen. Enrollment is for three months. It is possible that the early treatment of GIS might remedy this side effect associated with dabigatran.
The second drug to be FDA approved last month is the factor Xa inhibitor rivaroxaban (Xarelto). Although the drug has effects that last between 8 to 12 hours, factor Xa inhibition is not restored for 24 hours, making once daily dosing possible.
Trials have now been completed for the Xa inhibitor, apixaban (Eliquis). The results of this trial are promising. The drug will be submitted for FDA approval. Finally edoxaban, a fourth agent, is in Phase III studies with patients being followed and completion expected in 2012. These Xa inhibitor drugs are both twice daily dosing and do not appear to have significant GI upset side effects.
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