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Click here for updated Prescribing Information and Medication Guide with
updated BOXED WARNING REGARDING SPINAL/EPIDURAL HEMATOMA

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

PRADAXA delivers superior protection against stroke in NVAF vs warfarin
  • Primary efficacy endpoint: Superior 35% risk reduction of stroke/systemic embolism with PRADAXA 150 mg BID vs warfarin (134 vs 202 events, HR: 0.65, 95% CI [0.52, 0.81], P=0.0001)1,3
Superior reduction of ischemic/hemorrhagic stroke vs warfarin

(103 vs 134 events, HR: 0.75, 95% CI [0.58, 0.97], P=0.0296)

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

Superior reduction of ischemic/hemorrhagic stroke vs warfarin
  • Primary safety endpoint: Similar rate of major bleeds with PRADAXA vs warfarin (399 [3.3%] vs 421 [3.6%] events, HR: 0.93, 95% CI [0.81, 1.07])1,3
  • Higher rate of major GI bleeds (186 [1.6%] vs 125 [1.1%] events, HR: 1.50, 95% CI [1.2, 1.9]) and total GI bleeds (681 [6.1%] vs 452 [4.0%] events, HR: 1.52, 95% CI [1.35, 1.72]) with PRADAXA vs warfarin1,2
  • Lower rate of intracranial bleeds (38 [0.3%] vs 90 [0.8%] events, HR: 0.41, 95% CI [0.28, 0.60]) with PRADAXA vs warfarin1,3

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

Total number of strokes in the RE-LY Trial: 122 for PRADAXA vs 186 for warfarin (HR: 0.64, 95% CI [0.51, 0.81], P=0.0001).1,2

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.