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Hello, my name is Dr. Mark Alberts, Professor of Neurology and Director of the Stroke Program at Northwestern University and Northwestern Memorial Hospital. Today, I wanted to update you about a very exciting development in terms of stroke prevention in patients with atrial fibrillation. Just yesterday, the FDA [US Food and Drug Administration] Advisory Panel voted 9 to 0 in favor of approving dabigatran, which is a new direct thrombin inhibitor for the treatment of patients with atrial fibrillation. As you might recall, dabigatran was compared against warfarin in the recently published RE-LY study, which was published in the New England Journal of Medicine.
What this study found was that either dose of dabigatran, 110 mg twice a day or 150 mg twice a day, seemed to do as well if not better than warfarin for preventing strokes and systemic emboli in patients with atrial fibrillation. The dabigatran-treated patients seemed to have fewer side effects, particularly bleeding side effects, than the warfarin patients. The only apparent downside to dabigatran was a slight increase in myocardial infarction, which is as yet unexplained. One of the advantages of dabigatran, unlike warfarin, is that there are few, if any, medication or food interactions. And dabigatran does not require INR [international normalized ratio] monitoring frequently, as does warfarin.
This is really very exciting news. The FDA did approve the 150-mg dose twice a day of dabigatran, but the panel was split on the lower dose, 110 mg twice a day. So we'll have to see what happens with that. But the bottom line is that we are very close to having a new alternative to warfarin therapy that does not require frequent blood monitoring and seems to have few food and drug interactions. This is very exciting for our patients with atrial fibrillation and hopefully will lead to a decrease in the occurrence of stroke in patients with atrial fibrillation. Thank you very much for paying attention to this Medscape update on stroke.
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