The FDA announced the results of a new study on Medicare patients comparing Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim Pharmaceuticals) vs. warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.
In evaluating more than 134,000 Medicare patients ≥65 years of age, new users of Pradaxa were shown to have a lower risk of clot-related strokes, bleeding in the brain, and death compared to new patients taking warfarin. The MI risk was similar for both medications.
Pradaxa users had an increased risk of major GI bleeding vs. the warfarin users. This finding is consistent with the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial which showed that the risk of GI bleeding with Pradaxa compared to warfarin increased with age. However, the results for major GI bleeding differ from those of the previous Mini Sentinel Modular Program analysis which found lower rates of GI and intracranial hemorrhages among new users of Pradaxa, compared to new users of warfarin. The FDA will continue to investigate the reasons for differences in major GI bleeding rates for Pradaxa and warfarin observed in the Mini-Sentinel and Medicare analyses.
Pradaxa is currently indicated to reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5–10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients.
Warfarin is indicated for venous thrombosis, pulmonary embolism, thromboembolic complications from atrial fibrillation and/or cardiac valve replacement, and reduction in risk of death, recurrent MIs, and thromboembolic events (eg, stroke, systemic embolization) post-MI.
The FDA has no plans to make changes to the current label or recommendations for use of Pradaxa based on these results. Healthcare professions and patients are encouraged to report Pradaxa or warfarin side effects to the FDA MedWatch program.
For more information visit FDA.gov.