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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
  1. HRS, hepatorenal syndrome; NA, not applicable; PK, pharmacokinetic