Table 4.
Efficacy and safety of edoxaban in atrial fibrillation [28]
| ENGAGE-AF TIMI 48 trial outcomes | Warfarin (n = 7036) Patients/year, % |
Edoxaban 30 mga (n = 7034) Patients/year, % |
Hazard ratio | Edoxaban 60 mga (n = 7035) Patients/year, % |
Hazard ratio | |
|---|---|---|---|---|---|---|
| Efficacy | Stroke and systemic embolism | 1.5 | 1.61 | 1.07 (97.5% CI 0.87–1.31) | 1.18 | 0.79 (97.5% CI 0.63–0.99) |
| Stroke | 1.69 | 1.91 | 1.13 (95% CI 0.97–1.31) | 1.49 | 0.88 (95% CI 0.75–1.03) | |
| Systemic embolism | 0.12 | 0.15 | 1.24 (95% CI 0.72–2.15) | 0.08 | 0.65 (95% CI 0.34–1.24) | |
| Safety | Major bleedingb | 3.43 | 1.61 | 0.47 (95% CI 0.41–0.55) | 2.75 | 0.80 (95% CI 0.71–0.91) |
| CRNMBb | 10.15 | 6.60 | 0.66 (95% CI 0.60–0.71) | 8.67 | 0.86 (95% CI 0.79–0.93) | |
| CRNMB and major bleeding | 13.02 | 7.97 | 0.62 (95% CI 0.57–0.67) | 11.01 | 0.86 (95% CI 0.80–0.92) | |
| Fatal bleeding | 0.38 | 0.13 | 0.35 (95% CI 0.21–0.57) | 0.21 | 0.55 (95% CI 0.36–0.84) | |
| Intracranial hemorrhage | 0.85 | 0.26 | 0.30 (95% CI 0.21–0.43) | 0.39 | 0.47 (95% CI 0.34–0.63) | |
| Life threatening bleeding | 0.78 | 0.25 | 0.32 (95% CI 0.23–0.46) | 0.40 | 0.51 (95% CI 0.38–0.70) | |
| Gastrointestinal bleeding | 1.23 | 0.82 | 0.67 (95% CI 0.53–0.83) | 1.51 | 1.23 (95% CI 1.02–1.50) | |
CRNMB clinically relevant non-major bleeding
aIn the ENGAGE AF-TIMI 48 trial, edoxaban dosage was halved (from 60 to 30 mg or from 30 to 15 mg, respectively) if any of the following characteristics were present: CrCl 30–50 ml/min, body weight ≤60 kg, or concomitant use of verapamil or quinidine or dronedarone (potent P-glycoprotein inhibitors)
bSubgroup of patients within the ENGAGE AF-TIMI 48 trial with CrCl ≤95 ml/min had rates of major bleeding of 3.1% and 3.7% with edoxaban 60 mg and warfarin, respectively (HR 0.84; 95% CI 0.73–0.97), and rates of CRNMB of 9.4% and 10.9% with edoxaban 60 mg and warfarin, respectively (HR 0.87; 95% CI 0.80–0.95)