Table 3.
Pharmacodynamic parameters (inhibition of Factor Xa activity and relative prolongation of prothrombin time) after the administration of a single 10 mg dose of oral rivaroxaban to healthy controls and subjects with mild, moderate and severe renal impairment
| Renally impaired groups | ||||
|---|---|---|---|---|
| Healthy controls (n=8) | Mild impairment (n=8) | Moderate impairment (n=8) | Severe impairment (n=8) | |
| Inhibition of Factor Xa activity | ||||
| AUEC (% h) | 355.0 (40.1) | 536.1 (46.8) | 692.0 (33.3) | 743.5 (34.2) |
| AUEC ratio (90% CI) vs. healthy controls* | – | 1.50 (1.07, 2.10) | 1.86 (1.34, 2.59) | 2.00 (1.44, 2.78) |
| Emax (%) | 46.5 (18.6) | 49.7 (30.9) | 53.2 (15.1) | 54.0 (16.8) |
| Emax ratio (90% CI) vs. healthy controls* | – | 1.09 (0.96, 1.25) | 1.10 (0.97, 1.26) | 1.12 (0.99, 1.27) |
| Prolongation of prothrombin time | ||||
| AUEC (% h) | 15.4 (41.4) | 21.0 (47.8) | 33.6 (24.0) | 37.9 (43.7) |
| AUEC ratio (90% CI) vs. healthy controls* | – | 1.33 (0.92, 1.92) | 2.16 (1.51, 3.10) | 2.44 (1.70, 3.49) |
| Emax (%) | 1.4 (5.7) | 1.5 (7.9) | 1.7 (10.5) | 1.7 (7.8) |
| Emax ratio (90% CI) vs. healthy controls* | – | 1.04 (0.98, 1.10) | 1.17 (1.11, 1.24) | 1.20 (1.13, 1.27) |
Data are given as geometric mean (% coefficient of variation) unless indicated otherwise.
*
Calculated by analysis of variance.
AUEC, area under the effect curve between rivaroxaban administration and time of last observation (48 h); CI, confidence interval; Emax, maximum effect.