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Atrial fibrillation: risk of bleeding with Dabigatran, an oral thrombin inhibitor

It remains unclear whether Dabigatran etexilate mesylate ( Pradaxa ) is associated with higher risk of bleeding than Warfarin sodium ( Coumadin ) in real-world clinical practice.

A study has compared the risk of bleeding associated with Dabigatran and Warfarin using Medicare data.

In this retrospective cohort study, researchers used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries.
Participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated Dabigatran or Warfarin treatment within 60 days of initial diagnosis were identified.
The patients were followed up until discontinued use or switch of anticoagulants, death, or December 31, 2011.

Dabigatran users were 1302, and Warfarin users 8102.

Researchers identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or Emergency department stays for hematuria, gastrointestinal, or other hemorrhage.

They used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding.
The risk of bleeding for 4 subgroups of high-risk patients was examined: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities.

Dabigatran was associated with a higher risk of bleeding relative to Warfarin, with hazard ratios of 1.30 ( 95% CI, 1.20-1.41 ) for any bleeding event, 1.58 ( 95% CI, 1.36-1.83 ) for major bleeding, and 1.85 ( 95% CI, 1.64-2.07 ) for gastrointestinal bleeding.

The risk of intracranial hemorrhage was higher among Warfarin users, with a hazard ratio of 0.32 ( 95% CI, 0.20-0.50 ) for Dabigatran compared with Warfarin.

Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed.

The risk of major bleeding among Dabigatran users was especially high for African Americans and patients with chronic kidney disease.

In conclusion, Dabigatran was associated with a higher incidence of major bleeding ( regardless of the anatomical site ), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage.
Thus, Dabigatran should be prescribed with caution, especially among high-risk patients. ( Xagena )

Hernandez I et al, JAMA Intern Med 2014; Published online