Dabigatran and Warfarin: Comparable Incidence of Bleeding

Dabigatran was at least as safe as warfarin in patients with atrial fibrillation.

The new oral anticoagulants introduced for patients with atrial fibrillation (dabigatran, rivaroxaban, and apixaban) are more efficacious and more convenient to use than warfarin. Although the clinical trials that led to FDA approval of these agents showed that they were not associated with an overall increase in bleeding events, accounts of serious bleeding, especially with dabigatran, have been reported (JW Oncol Hematol Jul 31 2012).

In view of these concerns about the safety of dabigatran, FDA investigators used insurance-claim data on inpatients with atrial fibrillation to compare rates of intracranial and gastrointestinal bleeding associated with dabigatran versus warfarin during a 15-month period. The table, which shows the number of bleeding events per 100,000 days at risk with each agent, indicates that the incidence of both gastrointestinal and intracranial hemorrhage was lower with dabigatran than with warfarin.

CITATION(S):

Southworth MR et al. Dabigatran and postmarketing reports of bleeding. N Engl J Med 2013 Apr 4; 368:1272.