March 02, 2021
The lower dose of edoxaban (Savaysa; Daiichi-Sankyo) evaluated in ENGAGE AF-TIMI 48 provides a net clinical benefit, according to a new analysis of the trial, suggesting it may be useful for some patients with atrial fibrillation (AF).
The trial evaluated two doses of the direct oral anticoagulant (DOAC) versus warfarin 60 and 30 mg once daily; both could be cut in half in patients meeting certain criteria. The rate of a net clinical outcome incorporating stroke/systemic embolism, major bleeding, or death was significantly lower in patients who received the lower- versus higher-dose regimen (7.26% vs 8.01%; HR 0.90; 95% CI 0.84-0.98).
However, there was a trade-off with the lower dose it was associated with a greater risk of stroke/systemic embolism compared with the higher dose but with reduced risks of major, intracranial, GI, and life-threatening bleeding.