Table 5.

Efficacy and safety of edoxaban in VTE treatment [29]

Hokusai-VTE trial outcomes		Warfarin Patients/year (n = 4122), %	Edoxabanb Patients/year (n = 4118), %	Hazard ratio	Patients who qualified for edoxaban 30 mga Patients/year		Hazard ratio
					Warfarin (n = 719), %	Edoxaban (n = 733), %
Efficacy	Recurrent VTE or VTE-related death	3.5	3.2	0.89 (95% CI 0.70–1.13) p < 0.001 for non-inferiority	4.2	3.0	0.73 (95% CI 0.42–1.26)
	Recurrent VTE or VTE-related death in patients with index DVT	3.3	3.4	1.02 (95% CI 0.75–1.38)
	Recurrent VTE or VTE-related death in patients with index PE	3.9	2.8	0.73 (95% CI 0.50–1.06)
Safety	Major bleeding and CRNMB	10.3	8.5	0.81 (95% CI 0.71–0.94) p = 0.004 for superiority	12.8	7.9	0.62 (95% CI 0.44–0.86)
	Major bleeding	1.6	1.4	0.84 (95% CI 0.59–1.21) p = 0.35 for superiority	3.1	1.5	0.50 (95% CI 0.24–1.03)
	CRNMB	8.9	7.2	0.80 (95% CI 0.68–0.93) p = 0.004 for superiority
	Any bleeding	25.6	21.7	0.82 (95% CI 0.75–0.90) p < 0.001 for superiority
	Fatal bleeding	0.2	<0.1
	Intracranial hemorrhage	0.1	0

CRNMB clinically relevant non-major bleeding, VTE venous thromboembolism

^aPatients within the Hokusai-VTE trial received Edoxaban 30 mg daily if CrCl 30–50 ml/min, body weight ≤60 kg, or receiving concomitant treatment with potent P-glycoprotein inhibitors. Comparison completed against only those warfarin patients with same characteristics

^bSubgroup of male patients within the Hokusai-VTE trial had statistically reduced bleeding outcomes than women, favoring edoxaban (6.1% edoxaban vs. 9.1% warfarin in males, and 11.7% edoxaban vs. 11.8% warfarin in females; p value for interaction of 0.0041) but no difference in efficacy. Subgroup of patients with INR percent time in therapeutic range <60% also derived statistically better reductions in primary safety outcome with edoxaban (6.9% edoxaban vs. 10.9% warfarin) compared to patients with ≥60% time in therapeutic range (9.2% edoxaban vs. 10% warfarin); p value for interaction of 0.0175