Table 2.
Peak and Trough Apixaban Concentrations by Dosing Regimen
| Dosing Regimen |
||||
|---|---|---|---|---|
| 5 mg Twice Daily (n = 91) |
2.5 mg Twice Daily (n = 24) |
|||
| Dosed per Label | Dosed Higher Than Label | Dosed per Label | Dosed Lower Than Label | |
| Total | 88 (97) | 3 (3) | 11 (46) | 13 (54) |
| Men, women | 58, 30 | 2, 1 | 2, 9 | 7, 6 |
| Peak concentrations (ng/mL) | ||||
| 83 (94) | 3 (100) | 11 (100) | 13 (100) | |
| 201 ± 90 | 233 ± 53 | 136 ± 87 | 132 ± 88 | |
| Compared to range for 5 mg twice dailya | ||||
| Above 95% range | 6 (7) | 0 (0) | 1 (9) | 1 (8) |
| Women | 6 | 0 | 1 | 0 |
| Below 5% range | 5 (6) | 0 (0) | 4 (36) | 5 (38) |
| Men | 5 | 0 | 0 | 4 |
| Compared to range for 2.5 mg twice dailyb | ||||
| Above 95% range | - | - | 2 (18) | 2 (15) |
| Women | 2 | 1 | ||
| Below 5% range | - | - | 1 (9) | 1 (8) |
| Men | 0 | 1 | ||
| Trough concentrations (ng/mL) | ||||
| 80 (91) | 3 (100) | 10 (91) | 11 (85) | |
| 109 ± 56 | 163 ± 48 | 65 ± 28 | 65 ± 31 | |
| Compared to range for 5 mg twice dailya | ||||
| Above 95% range | 4 (5) | 0 (0) | 0 (0) | 0 (0) |
| Women | 2 | 0 | - | - |
| Below 5% range | 1 (1) | 0 (0) | 2 (20) | 2 (18) |
| Men | 1 | 0 | 0 | 2 |
| Compared to range for 2.5 mg twice dailyb | ||||
| Above 95% range | - | - | 0 (0) | 0 (0) |
| Below 5% range | - | - | 2 (20) | 1 (9) |
| Men | 2 | 1 | ||
| Daily AUC (ng∗h/mL)c | ||||
| 75 (85) | 3 (100) | 10 (91) | 11 (85) | |
| 3,643 ± 1,540 | 4,784 ± 1,015 | 2,138 ± 905 | 2,056 ± 1,072 | |
Values are n (%) or mean ± SD. Percentages may not add to 100% due to rounding.
AUC = area under the concentration vs time curve.
a
Compared to estimated 5% to 95% range for apixaban 5 mg twice daily.35
b
Italics are compared to estimated 5% to 95% range for apixaban 2.5 mg twice daily per labelling.35
c
Participants with both peak and trough concentrations.