ENGAGE AF-TIMI 48 trial of Lixiana shows reduced rates of intracranial haemorrhage for patients with atrial fibrillation.- Daiichi Sankyo.

Daiichi Sankyo Europe announced new sub-analysis data from the ENGAGE AF-TIMI 48 trial, which demonstrates that patients with atrial fibrillation (AF) treated with Lixiana (edoxaban) for the prevention of stroke or systemic embolic events (SEE), had reduced rates of different types of intracranial haemorrhage (ICH, bleeding inside the skull), compared to those on warfarin. Providing insights on the rates of ICH by cause, the sub-analysis showed a 42% reduction in spontaneous ICH (HR 0.58 [0.41-0.81]), which occurred in 97 patients taking either edoxaban or warfarin, and a 62% reduction in traumatic ICH (HR 0.38 [0.23-0.63]), which occurred in 185 patients taking either edoxaban or warfarin, among patients taking edoxaban (60 mg or 30 mg dose reduced, once-daily) compared to warfarin.

These results build on the body of evidence supporting the use of edoxaban in clinical practice and follow results from the ENGAGE-AF-TIMI 48 trial, where edoxaban demonstrated non-inferiority to warfarin for the prevention of stroke or SEE in patients with AF, with significant reductions in cardiovascular mortality and major bleeding. The sub-analysis provides further insights into outcomes in edoxaban compared to warfarin by ICH subtype, with edoxaban (60 mg or 30 mg dose reduced, once-daily) treated patients having lower rates of intraparenchymal haemorrhage (IPH) (HR 0.55 [95% CI 0.38-0.78]) and subdural hematoma (SDH) (HR 0.36 [0.22-0.58]), and similar rates of subarachnoid haemorrhage (SAH) and ischemic stroke with haemorrhagic transformation (ISHT) (both p>0.05). The data was presented at the 4th European Stroke Organisation Congress (ESOC).