Table 1 Demographic and selected characteristics of patients with HRS in the population PK analysis
From: Pharmacokinetic and pharmacodynamic analyses of terlipressin in patients with hepatorenal syndrome
Variable | Statistic or category | Study 1 (n = 29) | Study 2 (n = 40) | Total (N = 69) |
|---|---|---|---|---|
Weight, kg | Mean | 89.1 | 89.4 | 89.3 |
Range | 58.0–170.0 | 43.0–134.0 |  43.0–170.0 | |
Age, years | Mean | 49.9 | 56.4 | 53.7 |
Range | 23–66 | 40–73 | 23–73 | |
Age Group, n (%) | Age <65 years | 27 (93.1) | 33 (82.5) | 60 (87.0) |
Age ≥65 years | 2 (6.9) | 7 (17.5) | 9 (13.0) | |
Sex, n (%) | Male | 23 (79.3) | 17 (42.5) | 40 (58.0) |
Female | 6 (20.7) | 23 (57.5) | 29 (42.0) | |
Race, n (%) | White | 26 (89.7) | 31 (79.5) | 57 (83.8) |
Black | 3 (10.3) | 5 (12.8) | 8 (11.8) | |
Asian | 0 (0.0) | 2 (5.1) | 2 (2.9) | |
Other | 0 (0.0) | 1 (2.6) | 1 (1.5) | |
Creatinine clearance, mL/min | Mean | 33.5 | 28.7 | 30.8 |
Range | 10.0–57.0 | 9.7–57.6 | 9.7–57.6 | |
Child-Pugh score | Mean | 11.4 | 10.5 | 10.9 |
Range | 8–15 | 6–15 |  6–15 | |
Dosing frequency | NA | Every 6 h | ||
PK sampling schedule | NA | Days 3, 6, 9, and 14 (or last treatment day, whichever came first). The sampling time points for each day included one time point from group A and one time point from group B. TIMEPOINT 1: 0.083, 0.5, 1.0, 2.0 h TIMEPOINT 2: 3.0, 4.0, 5.0, 6.0 h | Day 1: The sampling time points for each day included one time point from TIMEPOINTS A or B or C: TIMEPOINT A: 5, 6, 7, 8, 9, and 10 min (± 1 min) TIMEPOINT B (early phase): 0.5, 1, 1.5, and 2 h (± 5 min) TIMEPOINT C (late phase): 3, 3.5, 4, and 5 h (± 10 min) | NA |