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Dabigatran etixilate beats warfarin stroke prevention


Dabigatran etexilate 150mg twice daily consistently beats warfarin at preventing stroke linked to atrial fibrillation,  research suggests.

The findings are based on new data from two RE-LY® sub-group analyses presented at the 60thAnnual Scientific Session of the American College of Cardiology (ACC).

RE-LY® is the largest AF trial to date. It was a PROBE (prospective,randomised, open-label with blinded endpoint evaluation) trial designedto compare two fixed doses of the oral direct thrombin inhibitordabigatran (110mg and 150mg bid) each administered in a blinded manner,with open label warfarin.

Pradaxa® 110mg bid was shown to be aseffective as warfarin.

The sub-group analyses assessed the rate of stroke andsystemic embolism with dabigatran etexilate compared with well-controlledwarfarin in patients with different types of AF (paroxysmal,persistent, permanent) and according to a refined stroke risk score CHA2DS 2VASc, which complements the traditionally used CHADS 2 score and has been recommended in the current European guidelines.



The results showed that the reduction of stroke rates seen with dabigatran etexilate 150mg bid compared to well-controlled warfarin across all CHA 2DS 2VAScstroke risk groups were consistent with the overall RE-LY® trialconclusions [as indicated by the p-value for interaction=0.60], whichestablished the superiority of dabigatran etexilate 150mg bid versuswell-controlled warfarin 2

In addition, the CHA 2DS 2VASc data were consistent with results from a previous sub-group analysis using the CHADSscore, which showed that dabigatran etexilate 150mg bid reduced therate of stroke across all stroke risk groups, including the patients inthe high risk group [n=5,882].

Dabigatran etexilate 150mg and 110mg bid doses have a favourablebenefit-risk profile compared to warfarin, including in patients withlower CHA 2DS 2VASc scores.

Dabigatran etexilate 150mg bid offers improved efficacy versus well-controlled warfarin (median TTR = 67%)for the prevention of stroke irrespective of the type of AF(paroxysmal, persistent, permanent), consistent with the overall RE-LY®trial conclusions [as indicated by the p-value for interaction=0.16].


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