Table 1 Demographic and baseline clinical characteristics
 | ReFerm® n = 28 | Fresubin® n = 28 |
---|---|---|
Age (IQR), years | 62 (56–66) | 64 (58–68) |
Male sex, n | 25 (89%) | 22 (79%) |
Body mass index ≥ 30 kg/m2, n | 14 (50%) | 11 (39%) |
Type 2 diabetes, n | 6 (21%) | 3 (11%) |
Alcohol consumption | ||
 Abstinent ≥ 1 week prior to inclusion, n | 14 (50%) | 14 (50%) |
 Abstinent ≥ 1 year prior to inclusion, na | 7 (25%) | 9 (32%) |
 Average alcohol intake for active drinkers | 36 (14–60) | 36 (9–51) |
 (IQR), g/day | ||
 Phosphatidylethanol (IQR), µ/La | 0.16 (0.00–0.89) | 0.20 (0.00–1.28) |
Laboratory data | ||
 Alanintransaminase (IQR), U/L | 32 (20–50) | 28 (22–52) |
 Aspartattransaminase (IQR), U/L | 43 (26–78) | 36 (26–53) |
 Gamma-Glutamyltransferase (IQR), U/L | 163 (69–411) | 132 (66–465) |
 Bilirubin, (IQR), umol/L | 12 (10–20) | 12 (7–18) |
 Plateles (SD), 109/L | 164 (69) | 164 (44) |
 INR (SD) | 1.15 (0.13) | 1.14 (0.17) |
 Albumin (SD), g/L | 44 (4) | 44 (3) |
 C-reactive protein (IQR), mg/L | 2 (1–4) | 2 (1–4) |
 MELD-Na (IQR) | 9 (8–11) | 10 (8–12) |
 Child-Pugh class A, n | 28 (100%) | 28 (100%) |
Liver histology | ||
 α-SMA (IQR)b | 21.9 (17.7–38.7) | 19.7 (11.7–26.8) |
 Kleiner fibrosis stage 2/3/4, n | 2/6/18 | 2/9/15 |
 Lobular inflammation grade 0/1/2/3, n | 6/14/6/0 | 7/17/2/0 |
 Ballooning grade 0/1/2, n | 16/10/0 | 15/11/0 |
 Steatosis grade 0/1/2/3, n | 13/8/3/2 | 7/8/9/2 |
Non-invasive test of liver disease | ||
 TE (IQR), kPa | 27.5 (16.5–46.2) | 20.2 (13.4–27.0) |
 CAP (IQR), dB/m | 298.5 (240.0–335.0) | 304.5 (262.0–336.0) |
 2D-SWE (SD), kPa | 23 (13) | 22 (12) |
 PRO-C3 (SD), ng/mL | 27.0 (10.5) | 23.0 (7.2) |
 Enhanced Liver Fibrosis test (SD)c | 10.8 (1.0) | 10.5 (0.9) |
 Fibrosis-4 score (IQR)c | 2.8 (1.8–4.3) | 2.7 (1.8–4.4) |