Table 1.
Summary of Key Demographic and Baseline Characteristics
| Demographic measures | Terlipressin n = 56 | Placebo n = 56 |
|---|---|---|
| Age, mean, y (SD) | 50.6 (10.5) | 52.9 (11.4) |
| Sex, n (%) | 41 (73.2) Male | 39 (69.6) Male |
| Ethnic origin, n (%) | 51 (91.1) White | 49 (87.5) White |
| Child–Pugh score, mean (SD) | 11.7 (1.9) | 11.2 (1.8) |
| MELD score, mean (SD) | 33.4 (6.0) | 33.4 (6.3) |
| Serum creatinine, mean, mg/dL (SD) | 3.96 (2.19) | 3.85 (1.17) |
| Serum sodium, mean, mmol/L (SD) | 130.6 (6.9) | 132.4 (7.0) |
| Albumin, mean, g/dL (SD) | 2.6 (0.84) | 2.9 (0.79) |
| Bilirubin, mean, mg/dL (SD) | 15.0 (13.6) | 15.8 (15.1) |
| INR, mean (SD) | 2.3 (0.8) | 2.3 (1.1) |
| AST, mean, U/L (SD) | 104.8 (111.9) | 117.3 (143.2) |
| ALT, mean, U/L (SD) | 57.6 (76.4) | 63.1 (91.3) |
| Alcoholic hepatitis, n (%) | 20 (35.7) | 20 (35.7) |
| Factors associated with HRS development, n (%) | 30 (53.6) | 31 (55.4) |
| Infection | 14 (25.0) | 9 (16.1) |
| Gastrointestinal bleeding | 2 (3.6) | 3 (5.4) |
| Prior diuretic treatment | 12 (21.4) | 15 (26.8) |
| Large volume paracentesis | 5 (8.9) | 4 (7.1) |
| Cirrhosis, n (%) | 51 (91.1) | 51 (91.1) |
| Etiology of liver disease, n (%)a | ||
| Alcohol | 29 (51.8) | 29 (51.8) |
| Hepatitis C | 22 (39.3) | 19 (33.9) |
| Hepatitis B | 4 (7.1) | 1 (1.8) |
| Primary biliary cirrhosis | 2 (3.6) | 1 (1.8) |
| Hepatocellular carcinoma | 4 (7.1) | 6 (10.7) |
| Nonalcoholic steatohepatitis | 2 (3.6) | 5 (8.9) |
| History of esophageal variceal hemorrhage, n (%) | 27 (48.2) | 27 (48.2) |
| Ascites, n (%) | 54 (96.4) | 54 (96.4) |
| Diabetics, n (%) | 13 (23.2) | 13 (23.2) |
| Mean arterial pressure, mean, mm Hg (SD) | 75.5 (11.4) | 77.2 (13.6) |
| Prior octreotide, n (%) | 10 (17.9) | 11 (19.6) |
| Prior midodrine, n (%) | 11 (19.6) | 12 (21.4) |
INR, International normalized ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
a
Includes patients with more than 1 etiology of liver disease.