Phase III ENGAGE AF-TIMI 48 trial shows Lixiana (edoxaban) provides benefits in patients with different stroke risk.-Daiichi Sankyo.

Daiichi Sankyo announced new sub-analysis data, demonstrating that Lixiana (edoxaban) provides comparable efficacy and greater safety compared to warfarin, across NVAF patients with different stroke risk scores. The findings are based on a sub-analysis of the Effective aNticoaGulation with factor XA next GEneration in Atrial Fibrillation (ENGAGE AF-TIMI 48) clinical study, and provide more specific insights into the use of oral, once-daily direct factor Xa-inhibitor edoxaban compared to warfarin in NVAF patients grouped by stroke risk (as measured by CHA2DS2-VASc score).

The ENGAGE AF-TIMI 48 study has previously shown that once-daily edoxaban is as effective as warfarin for the prevention of stroke or SEEs, while significantly reducing the risk of bleeding. This new sub-analysis has established that the benefit of edoxaban over warfarin is maintained, with no significant effect modification by CHA2DS2-VASc score, which assesses stroke risk more accurately than the previously used CHADS2 score. While overall results from ENGAGE AF-TIMI 48 demonstrate that edoxaban provides superior safety for NVAF patients in terms of major bleeding risk compared to warfarin, this data further shows that the safety benefit remains in place in patients with higher CHA2DS2-VASc scores (p-int=0.99 for major bleeding).

Major bleeding is a key consideration in assessing appropriate treatment in NVAF, and as such, this data highlights the value of edoxaban for patients at varying levels of stroke risk. The results of the study are being presented at ESC Congress 2017.