Table 4.
Mean PT and aPTT values by treatment group on day 7 and at treatment completion
| Day 7 | Completion day of treatment | |||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Treatment group | Pre dose | 1 to 3 h | 4 to 8 h | Pre dose | 1 to 3 h | 4 to 8 h | |
| PT (s) | MiRI n | Edoxaban 30 mg | 29 | 29 | 29 | 30 | 29 | 28 |
| Mean (SD) | CLCR ≥50 to <80 mL/min | 13.7 (1.1) | 16.8 (3.6) | 17.4 (1.8) | 13.6 (1.0) | 17.6 (3.4) | 17.5 (2.1) | |
| SRI n | Edoxaban 15 mg (total) | 27 | 27 | 27 | 26 | 25 | 26 | |
| Mean (SD) | CLCR ≥15 to <30 mL/min | 14.0 (1.2) | 16.1 (2.1) | 16.2 (1.4) | 14.1 (1.1) | 15.9 (1.9) | 16.5 (1.6) | |
| Edoxaban 15 mg | 7 | 7 | 7 | 6 | 7 | 7 | ||
| CLCR ≥15 to <20 mL/min | 14.8 (1.3) | 16.9 (2.1) | 16.9 (1.1) | 15.0 (1.5) | 16.6 (2.3) | 17.1 (2.5) | ||
| Edoxaban 15 mg | 20 | 20 | 20 | 20 | 18 | 19 | ||
| CLCR ≥20 to <30 mL/min | 13.8 (1.0) | 15.8 (2.1) | 15.9 (1.4) | 13.9 (0.9) | 15.6 (1.8) | 16.3 (1.2) | ||
| Fondaparinux | 20 | 20 | 20 | 19 | 17 | 18 | ||
| CLCR ≥20 to <30 mL/min | 13.5 (0.9) | 13.6 (0.9) | 13.5 (0.9) | 13.7 (1.1) | 13.7 (1.1) | 13.6 (1.1) | ||
| aPTT (s) | MiRI n | Edoxaban 30 mg | 29 | 29 | 29 | 30 | 29 | 28 |
| Mean (SD) | CLCR ≥50 to <80 mL/min | 32.2 (3.3) | 37.7 (6.2) | 38.9 (6.3) | 31.7 (3.6) | 39.3 (7.5) | 39.8 (6.5) | |
| SRI n | Edoxaban 15 mg (total) | 27 | 27 | 27 | 26 | 25 | 26 | |
| Mean (SD) | CLCR ≥15 to <30 mL/min | 31.6 (3.5) | 35.7 (6.0) | 36.1 (4.2) | 31.0 (4.3) | 34.0 (4.8) | 35.6 (4.8) | |
| Edoxaban 15 mg | 7 | 7 | 7 | 6 | 7 | 7 | ||
| CLCR ≥15 to <20 mL/min | 32.7 (4.4) | 36.6 (7.3) | 36.2 (7.0) | 31.1 (4.9) | 34.2 (6.0) | 34.7 (7.0) | ||
| Edoxaban 15 mg | 20 | 20 | 20 | 20 | 18 | 19 | ||
| CLCR ≥20 to <30 mL/min | 31.2 (3.1) | 35.4 (5.7) | 36.1 (3.0) | 31.0 (4.2) | 34.0 (4.4) | 36.0 (3.8) | ||
| Fondaparinux | 20 | 20 | 20 | 19 | 17 | 18 | ||
| CLCR ≥20 to <30 mL/min | 32.5 (4.4) | 32.6 (4.5) | 32.3 (5.0) | 32.9 (3.9) | 33.2 (5.8) | 33.5 (4.7) | ||
aPTT = activated partial thromboplastin time; CLCR = creatinine clearance; MiRI = mild renal impairment; PT = prothrombin time; SD = standard deviation; SRI = severe renal impairment.