Label Update on Pradaxa Compared to Warfarin

Boehringer Ingelheim announced that the Pradaxa (dabigatran etexilate mesylate capsules) prescribing information has been updated to affirm that Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.

The label update was based on the results of the RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). Results showed that Pradaxa 150mg taken twice daily significantly reduced stroke and systemic embolism by 35% beyond the reduction achieved with warfarin in patients with atrial fibrillation. In addition, Pradaxa 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.

Pradaxa is an oral direct thrombin inhibitor indicated to reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation. Warfarin is a vitamin K antagonist indicated to reduce risk of death, recurrent myocardial infarctions (MI), and thromboembolic events (eg, stroke, systemic embolization) post-MI.

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