Sub-Analysis Shows Primary Benefits seen with RE-LY are Independent of Level of Centre-Based International Normalized Ratio Control

INGELHEIM, Germany, Sunday, August 2010 [ME NewsWire]:

* Dabigatran etexilate 150mg BID was superior to warfarin in the reduction of stroke and systemic embolism irrespective of centre-based International Normalized Ratio (INR) control1


* Dabigatran etexilate 110mg BID reduced the rates of major bleeding compared to warfarin irrespective of centre-based INR control1


* Both dosages of dabigatran etexilate were superior to warfarin in terms of intracranial hemorrhage (ICH) irrespective of centre based INR control. 1


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(BUSINESS WIRE)-- Boehringer Ingelheim today announced that results from a pre-specified sub-group analysis of the RE-LY® study (Randomized Evaluation of Long-Term Anticoagulation Therapy, Warfarin, Compared with Dabigatran) – the largest atrial fibrillation outcomes trial ever completed - were published in The Lancet. 1 The sub-group analysis assessed the effects of centre-based international normalized ratio (INR) control on study outcomes.


"These findings support the superiority of 150mg dabigatran twice daily and the non-inferiority of 110mg dabigatran twice daily versus warfarin for protection against stroke in atrial fibrillation irrespective of the quality of INR control that a centre can achieve," said Professor Lars Wallentin, Professor of Cardiology and Director of the Uppsala University, Sweden. "For secondary outcomes, such as non-haemorrhagic events and mortality, advantages of dabigatran were reported for sites with poorer INR control, whereas results were comparable in sites with better INR control. Overall, these results show that local standards of care affect the benefits of switching to new treatment alternatives.”


For each patient involved in the warfarin arm of the RE-LY® trial, the quality of warfarin treatment was calculated by establishing the time in therapeutic range (TTR). The average individual time in therapeutic range (iTTR; with a target INR of 2.0 – 3.0) for patients randomised to warfarin was 64%, which is a similar level of control seen in recently published prospective, randomised trials2,3. There were considerable variations in time in therapeutic range among the trial centres across the participating 44 countries. In the present sub-group analysis, each centre’s average of TTR (cTTR) was calculated as the average of all individual patient TTRs in the warfarin group. The distribution of cTTRs across study centres was investigated and interquartile limits were identified. The quartiles of cTTR for the warfarin patients were <57.1%, 57.1%-65.5%, 65.5%-72.6% and >72.6%. Outcomes were assessed across the three treatment arms (dabigatran etexilate 110mg BID, 150mg BID and warfarin).


Results demonstrated that:1

* Dabigatran etexilate 150mg BID was superior to warfarin in the reduction of stroke and systemic embolism independent of the level of centre-based INR control


* Dabigatran etexilate 110mg BID was similar to warfarin in the reduction of stroke and systemic embolism with lower rates of major bleeding independent of the level of centre-based INR control


* Both dosages of dabigatran etexilate were superior to warfarin in terms of intracranial hemorrhage (ICH) irrespective of centre based INR control


* Both dosages of dabigatran etexilate demonstrated advantages over warfarin in the reduction of secondary outcomes such as the composite of all cardiovascular events, total mortality and major bleeding at centres with poor INR control. The results for secondary outcomes were comparable between dabigatran etexilate and warfarin in centres with better INR control.


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