In non-valvular atrial fibrillation vs. warfarin in the RE-LY® Trial, superior protection against stroke.

PRADAXA is the only NOAC to deliver superior reduction of ischemic stroke vs warfarin1,2

  • Superior 35% risk reduction of stroke/systemic embolism with PRADAXA 150 mg BID vs warfarin (primary efficacy endpoint: 135 [2.2%] vs 203 [3.4%] events, HR: 0.65, 95% CI [0.52, 0.81], P=0.0001)1,3
Superior reduction of ischemic/hemorrhagic stroke vs warfarin

(104 [1.7%] vs 134 [2.2%] events, HR: 0.76, 95% CI [0.59, 0.98], P=0.0351)

Superior reduction of ischemic/hemorrhagic stroke vs warfarin

(12 [0.2%] vs 45 [0.8%] events, HR: 0.26, 95% CI [0.14, 0.49], P<0.0001)

  • Similar rate of major bleeds with PRADAXA vs warfarin (primary safety endpoint: 409 [3.4%] vs 426 [3.6%] events, HR: 0.94, 95% CI [0.82, 1.08])1,3
  • Higher rate of major GI bleeds (192 [1.6%] vs 128 [1.1%] events, HR: 1.5, 95% CI [1.2, 1.9]) and total GI bleeds (684 [5.7%] vs 454 [3.9%] events, HR: 1.5, 95% CI [1.4, 1.7]) with PRADAXA vs warfarin1,2
  • Lower rate of intracranial bleeds (39 [0.3%] vs 91 [0.8%] events, HR: 0.42, 95% CI [0.29, 0.61]) with PRADAXA vs warfarin1,3

*Please see the RE-LY Trial, including bleeding definitions.

Total number of strokes in the RE-LY Trial: 123 for PRADAXA vs 187 for warfarin (HR: 0.64, 95% CI [0.51, 0.81], P<0.001).1,2

Bleeding rates expressed per 100 patient-years (%).

NEXT: STROKE & AFIB

NVAF=non-valvular atrial fibrillation; NOAC=newer oral anticoagulant; HR=hazard ratio; CI=confidence interval; GI=gastrointestinal; RE-LY=Randomized Evaluation of Long-term anticoagulant therapY; AFib=atrial fibrillation.

References: 1. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.
2. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. 3. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; for the Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY Trial [Letter to the Editor]. N Engl J Med. 2010;363(19):1875-1876.