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Data Published in The Lancet Compare Dabigatran Etexilate to Dose-Adjusted Warfarin Across RE-LY® Trial Centers
Date:8/29/2010

RIDGEFIELD, Conn., Aug. 29 /PRNewswire/ -- Boehringer Ingelheim today announced results from a pre-specified, retrospective, un-blinded sub-analysis of the RE-LY® trial – the largest atrial fibrillation outcomes trial ever conducted(2) – were published in The Lancet.  The sub-analysis evaluated the primary outcomes of RE-LY® in relation to each center's average time in therapeutic range (cTTR) (INR 2.0-3.0) for patients taking warfarin.(1)

Study centers were placed into one of four groups based on cTTR (<57.1%, 57.1%-65.5%, 65.5%-72.6% and >72.6%).(1) Primary outcomes were assessed across the three treatment arms (dabigatran etexilate 110mg BID, dabigatran etexilate 150mg BID, warfarin)(1) and demonstrated:

  • There was no significant interaction between cTTR and stroke and systemic embolism for either dabigatran etexilate 110mg BID or dabigatran etexilate 150mg BID compared to warfarin (interaction p=0.89 and 0.20)(1)

  • There was no significant interaction between cTTR and major bleeding with dabigatran etexilate 110mg BID (interaction p=0.50); however, there was a significant interaction when comparing dabigatran etexilate 150mg BID to warfarin (interaction p=0.03), with lower rates at centers where INR control was low, and similar rates at centers where control was higher(1)

  • There was no significant interaction between cTTR and intracranial bleeding for either dabigatran etexilate 110mg BID or dabigatran etexilate 150mg BID compared to warfarin (interaction p=0.71 and 0.89)(1)

"Well-controlled warfarin is very effective for the prevention of stroke in patients with atrial fibrillation; however, we know in clinical practice there can be large variations in the level of control," said Dr. Michael Ezekowitz, professor & vice president, clinical research,
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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