Table 6.
Baseline-adjusted pharmacodynamic parameters for interleukin-6, tumour necrosis factor-α and C-reactive protein (pharmacodynamics population) by hepatic function group
| Parameter | Mild HI (n = 9) | Healthy match, mild HI (n = 9) | Moderate HI (n = 8) | Healthy match, moderate HI (n = 10) |
|---|---|---|---|---|
| Median AUEClast [pg h ml−1 (range)] | ||||
| Interleukin-6 | 4880 (1220–12 500) | 3650 (1510–18 500) | 4980 (851–34 700) | 3150 (961–11 600) |
| Tumour necrosis factor-α | 6900 (1670–14 600) | 3870 (1570–13 300) | 4250 (2470–30 200) | 5200 (2510–12 500) |
| Median TEobs,max [h (range)] | ||||
| Interleukin-6 | 3.03 (3.0–4.0) | 4.00 (3.0–4.0) | 3.50 (3.0–4.1) | 3.00 (3.0–4.2) |
| Tumour necrosis factor-α | 3.0 (2.0–3.3) | 3.00 (3.0–4.0) | 3.00 (2.0–3.0) | 3.00 (2.0–3.0) |
| Median Eobs,max (range) | ||||
| Interleukin-6 (pg ml−1) | 1620 (457–4100) | 1330 (482–6560) | 1780 (444–10 000) | 1150 (348–4230) |
| Tumour necrosis factor-α (pg ml−1) | 2580 (416–8220) | 1050 (493–5730) | 1120 (446–6450) | 2080 (685–5340) |
| C-Reactive protein (mg dl−1) | 2.02 (1.0–8.9) | 5.14 (3.2–7.5) | 1.54 (0.7–5.5)* | 4.97 (2.9–7.6)† |
Abbreviations are as follows: AUEClast, area under the effect–time curve from time 0 to time of the last point of quantifiable effect; Eobs,max, observed maximal effect; HI, hepatic impairment; and TEobs,max, time of first occurrence of Eobs,max.
*
*n = 7.
†
n = 9.