Review Article
Update on Edoxaban for the Prevention and Treatment of Thromboembolism: Clinical Applications Based on Current Evidence
Table 5
Summary of important edoxaban trials. [
32–
38].
| | Thromboprophylaxis after total knee replacement surgery | | Trial | Interventions | Duration (days) | | Total VTE (%) | Major and CRNM bleeding (%) |
| STARS E-3
(Phase III) | Edoxaban 30 mg QD versus | 11–14 | 716 | 7.4 | 6.2 | | Enoxaparin 20 mg BID | | | 13.9 | 3.7 | | | | | | ( for NI) |
() |
| | Thromboprophylaxis after total hip replacement surgery | | Trial | Interventions | Duration (days) | | Total VTE (%) | Major and CRNM bleeding (%) |
| | Phase IIb | Edoxaban | 7–10 | 903 | 28.2 () | 3.7 | | 15 mg QD | | | 21.2 () | | | 30 mg QD | | | 15.2 () | | | 60 mg QD | | | 10.6 () | | 90 mg QD
versus | | | | | | Dalteparin 2,500 IU QD | | | 43.5 | 6.2 () | | followed by 5,000 IU QD | | | | | | Phase IIb | Edoxaban | 11–14 | 264 | | | | 15 mg QD | | | 3.8 | 18 | 30 mg QD
versus | | | 2.8
| 21.2
| | Enoxaparin 20 mg BID | | | 4.1 | 21.8 | Phase III
STARS J-V | Edoxaban | 11–14 | 610 | | | 30 mg QD
versus | | | 2.4
| 2.6
| | Enoxaparin 20 mg BID | | | 6.9 | 3.7 | | | | | ( for NI) | |
| | Thromboprophylaxis after hip fracture surgery | | Trial | Intervention | Duration (days) | | Total VTE (%) | Major and CRNM bleeding (%) |
|
STARS J-IV
(Phase III) | Edoxaban | 11–14 | 92 | | | 30 mg QD
versus | | | 3.7
| 3.4
| | Enoxaparin 20 mg BID | | | 6.5 | 6.9 |
| | Treatment and secondary prevention of VTE | | Trial | Interventions | Duration (months) | | Total VTE (%) | Major and CRNM bleeding (%) |
|
Hokusai-VTE
(Phase III) | Enoxaparin or UFH/ | 3–12 | 8,292 | | | | Edoxaban 60 mg QD | | | 3.2 | 8.5 | (or reduced to 30 mg QD)
versus | | |
|
| | Enoxaparin or UFH/ | | | 3.5 | 10.3 | | warfarin (INR 2.0–3.0) | | | ( for NI) | () |
| | Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation | | Trial | Interventions | Duration (years) | | Annual rate of stroke and systemic embolism (%) | Annual rate for major bleeding (%) |
| |
ENGAGE-AF-TIMI 48 | Edoxaban | 2.8 | 21,105 | | | | 60 mg QD or | | | 1.18 ( for NI) | 2.75 () | | 30 mg QD (or reduced to 15 mg QD) | | | 1.61 ( for NI) | 1.61 () | | versus | | | | | | Warfarin (INR 2.0–3.0) | | | 1.50 | 3.43 |
|
|
, number of patients; NI, noninferiority; QD, once daily; BID, twice daily; VTE, venous thromboembolism; CRNM, clinically relevant nonmajor; IU, international units; mg, milligrams; UFH, unfractionated heparin; INR, international normalized ratio.
|
