Table 4.

Evidence for edoxaban in the prevention of VTE, including RCTs and meta-analysis

Study	Study information	Jadad score	Key outcomes (numbers expressed as %)
Robertson et al31	Number of participants: 27,945 11 RCTs Three studies on direct thrombin inhibitors, eight studies on oral factor Xa inhibitors; (four rivaroxaban, two apixaban, and two edoxaban)	n/a	Oral factor Xa inhibitors demonstrated a similar rate of recurrent VTE compared to warfarin (OR 0.89; 95% CI 0.73–1.07) and a lower rate of recurrent DVT (OR 0.75; 95% CI 0.57–0.98)
Fuji et al (STARS E-3)29	Number of participants: 716 RCT. All patients undergoing unilateral total knee arthroscopy Comparison: edoxaban 30 mg and subcutaneous enoxaparin 20 mg BD	5	Edoxiban superior when compared to enoxaparin in the prevention of VTE. Absolute risk reduction of 6.5% Efficacy: 7.4 vs 13.0 (P<0.001) Safety: 6.2 vs 3.7 (P=0.129)
Fuji et al (STARS J-4)32	Number of participants: 92 RCT. Patients undergoing surgery for trochanteric or subtrochanteric fractures Edoxaban 30 mg compared to subcutaneous enoxaparin 20 mg BD	5	Rates of VTE with edoxaban and enoxaparin were 6.5% and 3.7%, respectively, and bleeding rates were 3.4% and 6.9%, respectively
Fuji et al (STARS J-V)30	Number of participants: 610 Phase III, double-blinded study. Patients undergoing elective, unilateral total knee arthroplasty Edoxaban 30 mg OD or enoxaparin 2,000 IU twice daily for 11–14 days.	5	Edoxaban superior to subcutaneous enoxaparin in the prevention of VTE; 2.4 vs 6.9 (P=0.0157). Major or clinically relevant nonmajor bleeding; 2.6 vs 3.7 (0.465)

Abbreviations: BD, twice daily; CI, confidence interval; DVT, deep vein thrombosis; OD, once daily; OR, odds ratio; RCTs, randomized controlled trials; VTE, venous thromboembolism; n/a, not applicable; IU, international units.