Boehringer Ingelheim announces sub-analysis result of RE-LY trial

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– 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.

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>
• There was no significant interaction between cTTR and major bleeding with dabigatran etexilate 110mg BID (interaction>
• 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>

"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, Lankenau Institute.  "The results of this sub-analysis suggest the level of control achieved across RE-LY trial centers did not influence the effects of dabigatran etexilate compared to warfarin for stroke prevention."

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.