Comparison with warfarin comes out well for dabigatran

Dabigatran (Pradaxa) was associated with a lower risk of clot-related strokes, intracranial hemorrhage, and death than warfarin, according to a recent study conducted by the FDA.

As part of an ongoing review of dabigatran, the agency conducted an observational cohort study of more than 134,000 Medicare patients who were age 65 or older, had a new diagnosis of atrial fibrillation (AF), and began taking either dabigatran or warfarin. Results showed patients on dabigatran had a lower risk of ischemic stroke, intracranial hemorrhage, and death; a similar risk of myocardial infarction (MI); and an increased risk of major gastrointestinal bleeding compared to those on warfarin.

These findings, with the exception of the MI finding, are consistent with results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial that supported FDA approval of dabigatran, the safety announcement said. Based on the new results, the FDA concluded that dabigatran has a favorable risk/benefit profile and made no changes to the label or recommendations for use. The agency plans to publish the results and to continue to investigate the risk of gastrointestinal bleeding.