Table 1.
Demographic and baseline clinical characteristics
| Rifaximin-α group (n=68) | Placebo group (n=68) | |||
|---|---|---|---|---|
| Age, years | 60 (53–64) | 60 (54–67) | ||
| Sex | ||||
| Male | 55 (81%) | 59 (87%) | ||
| Female | 13 (19%) | 9 (13%) | ||
| White race | 68 (100%) | 68 (100%) | ||
| Weight, kg | 89·0 (73·4–95·6) | 94·5 (83·0–108·1) | ||
| BMI, kg/m2 | 29·0 (25·5–31·6) | 30·9 (27·0–33·9) | ||
| Smoking | ||||
| Current | 27 (40%) | 26 (38%) | ||
| Previous | 18 (26%) | 24 (35%) | ||
| Never | 23 (34%) | 18 (26%) | ||
| Comorbidities | ||||
| Type 2 diabetes | 11 (16%) | 14 (21%) | ||
| Hypertension | 29 (43%) | 26 (38%) | ||
| Hypertriglyceridaemia* | 28 (41%) | 33 (49%) | ||
| Low HDL cholesterol† | 15 (22%) | 17 (25%) | ||
| Alcohol consumption | ||||
| Alcohol abstinence within the previous 6 months, yes | 8 (12%) | 8 (12%) | ||
| Daily alcohol consumption if not abstinent, g | 51 (36–84) | 51 (34–96) | ||
| Phosphatidylethanol, μmol/L | 0·69 (0·06–2·60) | 0·76 (0·06–1·40) | ||
| Years of excessive alcohol use | ||||
| 1–5 years | 6 (9%) | 10 (15%) | ||
| 6–10 years | 13 (19%) | 6 (9%) | ||
| 11–20 years | 19 (28%) | 19 (28%) | ||
| 21–30 years | 16 (24%) | 15 (22%) | ||
| >30 years | 14 (21%) | 17 (25%) | ||
| Liver parameters | ||||
| Alanine aminotransferase, U/L | 38 (25–55) | 39 (26–61) | ||
| Aspartate aminotransferase, U/L | 38 (24–64) | 37 (26–53) | ||
| Gamma glutamyl transferase, U/L | 93 (41–237) | 92 (52–289) | ||
| Alkaline phosphatase, U/L | 77 (67–99) | 82 (70–99) | ||
| Bilirubin, μmol/L | 10 (7–14) | 11 (7–14) | ||
| Platelet count, 109/L | 224 (179–263) | 222 (188–254) | ||
| International normalised ratio | 1·00 (0·97–1·09) | 1·00 (0·90–1·07) | ||
| Albumin, g/L | 43 (41–45) | 43 (41–47) | ||
| Liver histology | ||||
| Fibrosis stage | ||||
| 0 | 3 (4%) | 4 (6%) | ||
| 1 | 17 (25%) | 20 (29%) | ||
| 2 | 33 (49%) | 30 (44%) | ||
| 3 | 11 (16%) | 12 (18%) | ||
| 4 | 4 (6%) | 2 (3%) | ||
| Lobular inflammation score | ||||
| 0 | 7 (10%) | 6 (9%) | ||
| 1 | 40 (59%) | 35 (51%) | ||
| 2 | 17 (25%) | 25 (37%) | ||
| 3 | 4 (6%) | 2 (3%) | ||
| Ballooning score | ||||
| 0 | 42 (62%) | 38 (56%) | ||
| 1 | 20 (29%) | 25 (37%) | ||
| 2 | 6 (9%) | 5 (7%) | ||
| Steatosis grade | ||||
| 0 | 23 (34%) | 17 (25%) | ||
| 1 | 19 (28%) | 23 (34%) | ||
| 2 | 16 (24%) | 21 (31%) | ||
| 3 | 10 (15%) | 7 (10%) | ||
| Non-invasive test of liver fibrosis and steatosis | ||||
| Liver stiffness measured by transient elastography, kPa | 8·5 (6·5–11·8) | 8·6 (6·3–11·6) | ||
| Liver steatosis measured by controlled attenuation parameter, dB/m | 312 (268–340) | 318 (273–363) | ||
| Fibrosis-4 score | 1·6 (1·2–2·5) | 1·7 (1·1–2·3) | ||
Data are median (IQR) or n (%). The sum of percentages might deviate from 100 due to rounding.
*
Hypertriglyceridaemia defined as triglycerides ≥1·7 mmol/L.
†
Low HDL cholesterol defined as low if <1·03 mmol/L for men and <1·29 mmol/L for women.