Table 3.
Univariate Analyses of Apixaban Concentration Data for 5 mg Twice Daily Per Label
| 5 mg Twice Daily Dosing Regimen |
||||||||
|---|---|---|---|---|---|---|---|---|
| Peak Concentration (ng/mL) |
Trough Concentration (ng/mL) |
|||||||
| Difference in Means (95% CI) | P Valuea | Difference in Means (95% CI) | P Valuea | |||||
| Categorical | ||||||||
| Sex | ||||||||
| Male | 53 (64) | 174 ± 67 | Reference group | <0.001 | 55 (69) | 100 ± 47 | Reference group | 0.041 |
| Female | 30 (36) | 248 ± 105 | 74.9 (37.3 to 112.4) | 25 (31) | 128 ± 70 | 27.5 (1.1 to 54.0) | ||
| Race | ||||||||
| White | 74 (89) | 196 ± 78 | Reference group | 0.330 | 76 (95) | 107 ± 57 | Reference group | 0.489 |
| Black or African American | 7 (8) | 222 ± 182 | 26.0 (−44.5 to 96.5) | 1 (1) | 109 ± NA | 1.8 (−111.1 to 114.8) | ||
| Asian | 2 (2) | 282 ± 45 | 86.1 (−41.6 to 213.8) | 3 (4) | 147 ± 47 | 39.8 (−26.2 to 105.9) | ||
| Self-reported health status | ||||||||
| Very good or excellent | 43 (57) | 192 ± 67 | Reference group | 0.698 | 44 (56) | 102 ± 46 | Reference group | 0.522 |
| Good | 25 (33) | 209 ± 81 | 16.6 (−22.9 to 56.1) | 27 (34) | 117 ± 63 | 15.1 (−12.6 to 42.7) | ||
| Fair or poor | 8 (11) | 203 ± 123 | 10.5 (−50.0 to 71.0) | 8 (10) | 116 ± 85 | 13.5 (−30.0 to 56.9) | ||
| Clinical Frailty Score | ||||||||
| Very fit or Well | 38 (50) | 196 ± 75 | Reference group | 0.492 | 40 (51) | 104 ± 51 | Reference group | 0.147 |
| Managing well | 22 (29) | 189 ± 66 | −7.7 (−49.5 to 34.2) | 23 (29) | 100 ± 36 | −4.6 (−33.7 to 24.5) | ||
| Vulnerable or mildly frail | 16 (21) | 219 ± 100 | 22.4 (−24.2 to 68.9) | 16 (20) | 133 ± 85 | 28.9 (−4.0 to 61.8) | ||
| Combined CYP3A4/5-P-gp moderate inhibitors | ||||||||
| No inhibitors | 69 (83) | 191 ± 83 | Reference group | 0.032 | 69 (86) | 107 ± 57 | Reference group | 0.600 |
| Inhibitors | 14 (17) | 247 ± 110 | 56.0 (4.9 to 107.2) | 11 (14) | 117 ± 49 | 9.7 (−26.8 to 46.1) | ||
| Continuous | ||||||||
| 1 Additional daily medication | 11.1 (3.4 to 18.7) | 0.005 | 5.5 (0.4 to 10.6) | 0.036 | ||||
| Age (per 5 y) | 5.8 (−17.6 to 29.2) | 0.624 | 7.7 (−7.3 to 22.7) | 0.310 | ||||
| 10 mL/min decrease in CrCL | 17.7 (7.9 to 27.6) | <0.001 | 7.5 (0.5 to 14.5) | 0.035 | ||||
| Weight (per 5 kg) | −1.4 (−7.4 to 4.7) | 0.654 | −0.3 (−4.0 to 3.4) | 0.886 | ||||
| Charlson Comorbidity Score | 0.4 (−11.0 to 11.8) | 0.949 | 3.5 (−3.6 to 10.6) | 0.332 | ||||
Values are n (%) or mean ± SD.
CI = confidence interval; CrCL = creatinine clearance.
a
P value is based on overall F-test of univariate linear regression of concentration on selected characteristic.