Table 3.
Pharmacokinetic characteristics of liraglutide by degree of hepatic impairment
| Hepatic impairment group | ||||
|---|---|---|---|---|
| Healthy | Mild | Moderate | Severe | |
| AUC (0,∞) (pmol l−1 h) | ||||
| Mean (SD) | 179 641 (43 154) | 149 812 (70 007) | 154 615 (47 939) | 105 158 (40 843) |
| Min–Max | 114 195–218 365 | 87 851–273 622 | 91 623–208 707 | 54 724–153 211 |
| Cmax (pmol l−1) | ||||
| Mean (SD) | 6 746 (1 534) | 6 433 (3 859) | 5 593 (1 558) | 4 872 (1 637) |
| Min–Max | 4 852–8 978 | 4 162–14 202 | 4 003–7 952 | 2 769–7 506 |
| tmax (h) | ||||
| Mean (SD) | 12.3 (2.3) | 11.3 (3.8) | 12.7 (2.3) | 13.2 (2.9) |
| Min–Max | 9–15 | 4–14 | 10–15 | 8–16 |
| t1/2 (h) | ||||
| Mean (SD) | 11.2 (1.0) | 10.7 (1.1) | 11.4 (2.2) | 9.5 (1.0) |
| Min–Max | 9.9–12.3 | 9.1–12.0 | 9.7–15.6 | 8.1–10.7 |
| CL/F (l h−1) | ||||
| Mean (SD) | 1.18 (0.33) | 1.55 (0.59) | 1.42 (0.51) | 2.21 (0.99) |
| Min–Max | 0.92–1.75 | 0.73–2.28 | 0.96–2.18 | 1.30–3.65 |
| Vz/F (l) | ||||
| Mean (SD) | 18.7 (3.8) | 23.5 (7.9) | 23.1 (8.2) | 30.2 (13.5) |
| Min–Max | 15.6–25.0 | 11.9–32.3 | 14.1–33.9 | 16.8–50.1 |
AUC(0,∞), area under the liraglutide plasma concentration–time curve from time zero to infinity. The measurements were performed up to 72 h after liraglutide dosing. Cmax, maximum liraglutide plasma concentration. tmax, time to reach maximum liraglutide concentration. t1/2, terminal plasma half-life calculated as t1/2 = ln2/λz. λz, terminal elimination rate constant, calculated by log-linear regression on the log linear phase of the plasma concentration profile. CL/F, total apparent clearance, estimated as CL/F = dose/AUC. Vz/F, apparent volume of distribution, estimated as Vz/F = (CL/F)/λz.