The direct oral factor Xa inhibitor edoxaban was found to be noninferior to well-managed warfarin for preventing strokes or systemic embolism in patients with atrial fibrillation.
The direct oral factor Xa inhibitor edoxaban was found to be noninferior to well-managed warfarin for preventing strokes or systemic embolism in patients with atrial fibrillation, according to a study recently published in the New England Journal of Medicine.
The study found that edoxaban was associated with lower rates of bleeding and death from cardiovascular causes when compared to warfarin, the most prescribed anticoagulant medicine.
The results of the study have some medical officials optimistic that FDA may soon approve edoxaban as an alternative way to reduce stroke risks in patients with atrial fibrillation. Other oral anticoagulants – rivaroxaban, apixaban, and dabigatran – are considered more convenient alternatives to warfarin, the vitamin K antagonist.
“We know this drug [edoxaban] is safer than warfarin, particularly the low dose,” said Robert Giugliano, MD, associate professor of medicine, Harvard Medical School, and the study’s lead author.
Researchers conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate- to high-risk atrial fibrillation. The edoxaban regimens were tested for noninferiority to warfarin.
They found that patients taking the edoxaban versus warfarin had a reduced risk of major bleeding that ranged from 20% to 53%. Patients receiving the low-dose edoxaban (30 mg) had a 1.61% rate of major bleeds; patients receiving the high-dose edoxaban (60 mg) had a 2.75% rate; and patients receiving warfarin had a 3.43% annual rate of major bleeds.
The edoxaban patients also experienced a lower rate of cardiovascular deaths. The cardiovascular death rate for those who received low-dose edoxaban was 2.71%; 2.74% for those who received high-dose edoxaban; and 3.17% for those receiving warfarin.
“Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes,” the study concluded.
Warfarin outperformed edoxaban in relation to gastrointestinal bleeding and ischemic stroke. The edoxaban patients (1.51%) were more likely to have gastrointestinal bleeding than the warfarin patients (1.23%). And more patients taking low-dose edoxaban (1.77%) suffered ischemic strokes than those taking warfarin (1.25%).
Earlier this month, Daiichi Sankyo submitted a Marketing Authorization Application for edoxaban to the European Medicines Agency.