Abstract
Unlike other international regulatory agencies, the US FDA did not approve the dabigatran 110mg dose for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Such decision was based on the review of the results from the RE-LY trial, after which the US FDA concluded there was no subgroup of patients for whom dabigatran 110mg was not inferior to dabigatran 150mg. Recently, observational studies based on US data have found that the safety profile of dabigatran differs between subgroups, considerably more than what was suggested in clinical trials. In addition, post hoc analyses of the RE-LY trial support the use of dabigatran 110mg in high-risk patients, as recommended by the European label. Based on this new evidence, the US FDA should reconsider the approval of the dabigatran 110mg dose. The availability of dabigatran 110mg may be especially favorable for groups of patients for whom dabigatran has been associated with higher risk of bleeding than warfarin, which represent a high proportion of the patients recommended for oral anticoagulation. In addition, the approval of this intermediate strength would increase prescribers' and patients' flexibility in the choice of oral anticoagulant.
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