Table 2.
RCT comparing edoxaban to warfarin therapy in the prevention of AF-related ischemic strokes
| Study | Study information | Jadad score | Key outcomes (numbers expressed as %) |
|---|---|---|---|
| Weitz et al19 | Number of participants; 1,146 Randomized open-label drug, double blinded 3-month follow-up Comparison: Edoxaban 30 mg OD (N: 235) Edoxaban 30 mg BD (N: 245) Edoxaban 60 mg OD (N: 235) Edoxaban 60 mg BD (N: 180) and standardized warfarin therapy INR 2–3 (N: 251) |
5 | Edoxaban OD noninferior to warfarin. Bleeding: 30 mg OD; 5.5 (P=0.367) 30 mg BD; 12.7 (P=0.104) 60 mg OD; 3.9 (P=0.864) 60 mg BD; 18.3 (P=0.002) Warfarin; 8.0 Major bleeding: 30 mg OD; 3.0 (P=1.0) 30 mg BD; 7.8 (P=0.029) 60 mg OD; 3.9 (P=0.807) 60 mg BD; 10.6 (P=0.002) Warfarin; 3.2 Major cardiovascular event: 30 mg OD; 1.7 30 mg BD; 2.5 60 mg OD; 4.3 60 mg BD; 1.1 Warfarin; 2.4 |
| Chung et al24 | Number of participants; 234 Randomized open-label, double-blinded dose. 3-month follow-up Comparison: Edoxaban 30 mg OD Edoxaban 60 mg OD to warfarin (INR 2–3) |
5 | Edoxaban noninferior to warfarin. Bleeding: 30 mg OD; 20.3 60 mg OD; 23.8 Warfarin; 29.3 Major bleeding: 30 mg OD; 0 60 mg OD; 7.5 Warfarin; 6.6 Major cardiovascular event: 30 mg OD; 2.5 60 mg OD; 3.8 Warfarin; 1.3 |
| Yamashita et al25 | Number of participants; 546 Randomized, double-blinded trial. 3-month follow-up Comparison: Edoxaban 30 mg OD Edoxaban 45 mg OD Edoxaban 60 mg OD with warfarin treatment (INR 2–3) |
5 | Edoxaban noninferior to warfarin. Bleeding: 30 mg OD; 18.5 45 mg OD; 22.4 60 mg OD; 27.7 Warfarin; 20 Major bleeding: 30 mg OD; 1.5 45 mg OD; 5.2 60 mg OD; 5.4 Warfarin; 3.2 |
Abbreviations: BD, twice daily; OD, once daily; RCTs, randomized controlled trials; AF, atrial fibrillation; INR, international normalized ratio.