Table 1.
Baseline demographic, biochemical, histologic and cardiovascular characteristics of patients.
| Ezetimibe arm (n = 25) | Placebo arm (n = 25) | p value | |
|---|---|---|---|
| Demographics | |||
| Female participants | 14 (56%) | 17 (68%) | 0.3821 |
| Age (years) | 49.0 ± 14.9 | 49.5 ± 13.7 | 0.9139 |
| Height (m) | 1.7 ± 0.1 | 1.7 ± 0.1 | 0.9837 |
| Weight (kg) | 94.1 ± 18.1 | 91.8 ± 18.9 | 0.6662 |
| BMI (kg/m2) | 33.8 ± 5.2 | 32.9 ± 5.1 | 0.5432 |
| Race and ethnicity | |||
| White (versus non-White) | 19 (76%) | 21 (84%) | 0.7252 |
| Hispanic (versus non-Hispanic) | 8 (32%) | 9 (36%) | 0.7653 |
| Diabetes | 7 (28%) | 7 (28%) | 1.0000 |
| Biochemical profile | |||
| AST (IU/L) | 33.0 (23.0) | 32.0 (28.0) | 0.6572 |
| ALT (IU/L) | 51.0 (29.0) | 47.0 (26.0) | 0.9615 |
| Alkaline phosphatase (U/l) | 72.0 (29.0) | 72.0 (37.0) | 0.4584 |
| GGT (U/l) | 49.0 (32.0) | 32.5 (42.0) | 0.4049 |
| Total bilirubin (mg/dl) | 0.5 (0.4) | 0.4 (0.2) | 0.7167 |
| Direct bilirubin (mg/dl) | 0.1 (0.0) | 0.1 (0.1) | 0.3494 |
| Albumin (g/dl) | 4.5 (0.3) | 4.5 (0.4) | 0.3830 |
| Glucose (mg/dl) | 104.0 (25.0) | 106.0 (41.0) | 0.6504 |
| HbA1c (%) | 5.9 (0.7) | 6.1 (1.0) | 0.7015 |
| Insulin (mlU/l) | 23.0 (15.5) | 26.5 (18.0) | 0.2322 |
| Total cholesterol (mg/dl) | 182.0 (25.0) | 170.0 (54.0) | 0.5001 |
| Triglycerides (mg/dl) | 152.0 (58.0) | 149.0 (104.0) | 0.5567 |
| HDL (mg/dl) | 45.0 (11.0) | 44.0 (22.0) | 0.7209 |
| LDL (mg/dl) | 100.0 (32.0) | 90.0 (50.5) | 0.3831 |
| Other | |||
| MRI-PDFF (%) | 11.3 (10.9) | 19.6 (11.1) | 0.0978 |
| NAS | 5.0 (2.0) | 5.0 (2.0) | 0.2116 |
| Cardiovascular risk scores | |||
| CAC score | n = 20 | n = 21 | 0.6616 |
| 0 | 12 | 15 | |
| 1–100 | 4 | 2 | |
| >100 | 4 | 4 | |
| Mean CAC score ± SD | 131.9 ± 484.0 | 127.3 ± 393.0 | 0.9739 |
| Median CAC score (IQR) | 0 (58.5) | 0(65) | 0.6793 |
| FRS | n = 25 | n = 25 | 0.3487 |
| <10% | 21 | 24 | |
| ⩾10% | 4 | 1 | |
| Mean FRS ± SD | 4.1 ± 6.0 | 2.9 ± 4.1 | 0.4375 |
| Median FRS (IQR) | 1.0 (4.5) | 1.0 (3.5) | 0.7902 |
Mean ± standard deviation presented above for normally distributed variables, median (interquartile range) for non-normally distributed variables. The Wilcoxon–Mann–Whitney test was performed on all continuous variables. A chi-squared or Fisher’s exact test was used for categorical variables.
The NAS-CRN histologic scoring system was used for histology grading and staging of liver biopsies.
AST, aspartate aminotransferase; ALT, alanine aminotransferase; BMI, body mass index; CAC, coronary artery calcium; FRS, Framingham risk score; GGT, γ-glutamyl transferase; HDL, high-density lipoprotein; HgA1c, hemoglobin A1C; IQR, interquartile range; IU, international unit; LDL, low-density lipoprotein; MRI-PDFF, magnetic resonance imaging proton-derived fat fraction; NAFLD, nonalcoholic fatty liver disease; NAS, NAFLD activity score; SD, standard deviation.