Table 2.
Phase III randomized clinical trials evaluating edoxaban efficacy and safety
| Study | Year | Study groups | Patients | Mean FU | Primary outcome |
|---|---|---|---|---|---|
| ENGAGE AF-TIMI 4820 | 2009 | Edoxaban 60 mg OD | 7,035 | 2.8 years | Stroke/SEE |
| Edoxaban 30 mg OD | 7,034 | ||||
| Dose-adjusted warfarin (INR 2–3) | 7,036 | ||||
| Hokusai-VTE46 | 2013 | Edoxaban 60 mg OD | 4,118 | 8.2 months | Recurrent symptomatic VTE |
| Dose-adjusted warfarin (INR 2–3) | 4,122 |
Abbreviations: FU, follow-up; INR, international normalized ratio; OD, once daily; SEE, systemic embolic event; VTE, venous thromboembolism.