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Video: RE-LY Trial Met Primary Outcome for Reducing Incidence of Stroke or Systemic Embolism in Non-valvular Atrial Fibrillation Patients
Date:8/30/2009

RIDGEFIELD, Conn., Aug. 30 /PRNewswire/ -- Boehringer Ingelheim today announced that results from the RE-LY(R) (Randomized Evaluation of Long-Term Anticoagulant Therapy, Warfarin, Compared with Dabigatran) study -- the largest atrial fibrillation (AF) outcomes trial ever conducted(1) (18,113 patients in 44 countries worldwide) -- were presented for the first time at the European Society of Cardiology Congress and published online in the New England Journal of Medicine.(2) The primary objective of RE-LY was to assess the safety and efficacy of the investigational oral direct thrombin inhibitor, dabigatran etexilate against warfarin (titrated to INR 2.0 to 3.0) for the prevention of stroke in patients with non-valvular atrial fibrillation.(1)

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/boehringeringelheim/39821/

The RE-LY study results have shown:

  • Both doses of dabigatran etexilate were non-inferior to warfarin on the primary endpoint of reducing the incidence of stroke (including hemorrhagic) and systemic embolism (p < 0.001)(2)
  • Dabigatran etexilate 150 mg BID was superior to warfarin in reducing the incidence of stroke (including hemorrhagic) and systemic embolism by 34 percent (RR 0.66, 95% CI, 0.53-0.82, p < 0.001)(2)
  • There was no significant difference in the rate of major bleeding for dabigatran 150 mg BID compared to warfarin (3.11 percent/year, 3.36 percent/year, respectively p=0.31)(2)
  • The rate of major bleeding with dabigatran etexilate 110 mg BID (2.71 percent/year) was 20 percent lower compared to warfarin (p=0.003)(2)

Also presented and published today were results in other outcomes from t
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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