Table 2.
Statistical comparison of anastrozole and placebo treatment groups to assess the effects of concomitant administration of anastrozole on the anticoagulant activity of warfarin.
| Anastrozole | Placebo | ||||||
|---|---|---|---|---|---|---|---|
| Parameter | n | glsmean | n | glsmean | Treatment effecta | 95% CI | P value |
| PT (s) | |||||||
| Pre-dose (day 3)b | 16 | 11.56 | 15 | 11.45 | 1.010 | 0.984,1.037 | 0.442 |
| AUC(8,94 h) | 16 | 17.45 | 15 | 18.36 | 0.951 | 0.860,1.052 | 0.299 |
| 166 hb | 16 | 11.27 | 15 | 11.31 | 1.023 | 0.987,0.983 | 0.015 |
| 240 hb | 16 | 11.56 | 15 | 11.31 | 1.023 | 0.987,1.059 | 0.193 |
| aPTT (s) | |||||||
| Pre-dose (day 3)b | 16 | 30.07 | 15 | 29.52 | 1.019 | 0.987,1.052 | 0.233 |
| AUC(8,94 h) | 16 | 34.96 | 15 | 36.07 | 0.969 | 0.919,1.023 | 0.237 |
| 166 hb | 16 | 29.43 | 14c | 31.72 | 0.928 | 0.889,0.968 | 0.002 |
| 240 hb | 16 | 29.94 | 15 | 29.74 | 1.007 | 0.968,1.047 | 0.722 |
| TT (s) | |||||||
| Pre-dose (day 3)b | 16 | 18.64 | 15 | 18.23 | 1.023 | 0.991,1.055 | 0.148 |
| AUC(8,94 h) | 16 | 18.86 | 15 | 18.68 | 1.010 | 0.979,1.042 | 0.505 |
| 166 hb | 16 | 18.72 | 14c | 19.05 | 0.983 | 0.935,1.034 | 0.474 |
| 240 hb | 16 | 19.06 | 15 | 18.75 | 1.017 | 0.980,1.054 | 0.350 |
| Factor VII (%) | |||||||
| Pre-dose (day 3)b | 16 | 109.59 | 15 | 103.34 | 1.060 | 0.925,1.215 | 0.366 |
| AUC(8,22 h) | 16 | 51.09 | 15 | 46.04 | 1.110 | 0.982,1.254 | 0.088 |
| AUC(22,94 h) | 16 | 30.94 | 15 | 28.67 | 1.079 | 1.908,1.284 | 0.355 |
| 166 hb | 16 | 108.96 | 15 | 98.72 | 1.104 | 0.970,1.256 | 0.123 |
| 240 hb | 16 | 97.81 | 15 | 107.26 | 0.912 | 0.821,1.012 | 0.079 |
glsmean of the anastrozole phase divided by the glsmean of the placebo phase.
times relate to dosing of warfarin.
value not recorded for subject 0006. CI: confidence interval, PT: prothrombin time, aPTT: activated thromboplastin time, TT: thrombin time, AUC: area under the pharmacodynamic-time curve, glsmean: geometric least squares mean.