Table 4.
Between-group comparison of liraglutide pharmacokinetics. Ratios and 90% CI comparing hepatically impaired groups to the healthy subject group
Hepatic impairment group | |||
---|---|---|---|
Mild/healthy | Moderate/healthy | Severe/healthy | |
AUC (0,∞) Estimate (90% CI) | 0.77 (0.53, 1.11) | 0.87 (0.60, 1.25) | 0.56 (0.39, 0.81) |
Cmax Estimate (90% CI) | 0.89 (0.65, 1.21) | 0.80 (0.59, 1.09) | 0.71 (0.52, 0.97) |
t1/2 (h) Estimate (90% CI) | 0.95 (0.83, 1.10) | 1.01 (0.88, 1.17) | 0.85 (0.73, 0.98) |
CL/F Estimate (90% CI) | 1.30 (0.90, 1.87) | 1.15 (0.80, 1.66) | 1.78 (1.23, 2.58) |
Vz/F Estimate (90% CI) | 1.23 (0.86, 1.77) | 1.17 (0.82, 1.67) | 1.51 (1.05, 2.17) |
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.