Table 3.
Aramchol (n=22) | Placebo (n=21) | Difference | |||||
---|---|---|---|---|---|---|---|
Baseline | Posttreatment | P-Value | Baseline | Posttreatment | P-Value | P-Value | |
Weight (kg) | 89.3 (11.9) | 90.0 (8.2) | 0.6486 | 87.3 (18.8) | 85.4 (20.5) | 0.4683 | 0.3685 |
BMI (kg/m2) | 30.4 (4.3) | 30.1 (4.3) | 0.2919 | 29.1 (3.1) | 29.3 (4.0) | 0.0831 | 0.0595 |
ALT (IU/L) | 58.0 (53.0) | 51.0 (37.0) | 0.0002 | 43.0 (26.0) | 36.0 (44.0) | 0.1211 | 0.1051 |
AST (IU/L) | 40.5 (29.0) | 37.0 (15.0) | 0.0189 | 28.5 (25.0) | 25.5 (16.0) | 0.1572 | 0.5180 |
AST:ALT | 0.6 (0.2) | 0.7 (0.3) | 0.0002 | 0.7 (0.2) | 0.7 (0.3) | 0.4392 | 0.1625 |
Alk Phos (U/L) | 77.0 (31.0) | 80.5 (32.0) | 0.5437 | 79.5 (42.0) | 76.5 (41.0) | 0.1478 | 0.2003 |
Total bilirubin (mg/dL) | 0.6 (0.3) | 0.5 (0.3) | 0.4484 | 0.5 (0.3) | 0.4 (0.4) | 0.1172 | 0.5262 |
Direct bilirubin (mg/dL) | 0.2 (0.0) | 0.2 (0.0) | 1.0000 | 0.2 (0.0) | 0.2 (0.0) | 0.5000 | 0.3101 |
Albumin (g/dL) | 4.5 (0.4) | 4.5 (0.2) | 0.2366 | 4.5 (0.2) | 4.5 (0.3) | 0.1928 | 0.0830 |
Protime (s) | 11.2 (0.7) | 11.3 (0.9) | 1.0000 | 11.4 (0.9) | 11.2 (1.1) | 0.8138 | 0.8785 |
Triglycerides (mg/dL) | 166.0 (79.0) | 180.0 (184.0) | 0.0797 | 187.0 (165.0) | 159.0 (147.0) | 0.2764 | 0.0907 |
Total cholesterol (mg/dL) | 177.0 (58.0) | 187.0 (181.0) | 0.0029 | 179.0 (54.0) | 169.0 (37.0) | 0.7683 | 0.0176 |
LDL (mg/dL) | 110.0 (45.0) | 113.0 (42.0) | 0.0450 | 96.0 (27.0) | 102.0 (37.5) | 0.8910 | 0.2352 |
FFA (mmol/L) | 0.6 (0.2) | 0.5 (0.3) | 0.4894 | 0.7 (0.2) | 0.5 (0.2) | 0.0006 | 0.0559 |
Glucose (mg/dL) | 98.0 (17.0) | 101.0 (19.0) | 0.8017 | 107.5 (36.0) | 98.5 (24.0) | 0.0357 | 0.2218 |
Insulin (μU/mL) | 29.5 (17.0) | 25.5 (19.0) | 0.9919 | 24.5 (25.0) | 23.0 (19.0) | 0.2798 | 0.2448 |
HOMA-IR | 7.2 (4.6) | 6.3 (4.7) | 0.7756 | 6.2 (8.2) | 5.6 (5.9) | 0.1756 | 0.2177 |
Hgb A1C (%) | 5.4 (0.4) | 5.4 (0.4) | 0.7646 | 5.6 (0.7) | 5.6 (0.7) | 0.2188 | 0.1266 |
CD4 count (cells/mm3) | 644.0 (354.0) | 640.0 (469.0) | 0.5412 | 680.0 (383.0) | 633.0 (371.0) | 0.7500 | 0.4813 |
Data are expressed as median (IQR) with p-values from Wilcoxon signed rank test or mean difference with P-value in parentheses. P-values in bold denote statistical significance < 0.05.
BMI, Body Mass Index; AST, Aspartate Aminotransferase; ALT, Alanine Aminotransferase; Hgb A1c, hemoglobin A1c; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; FFA, Free Fatty Acids; Alk Phos, Alkaline Phosphatase; GGT, Gamma-Glutamyl Transferase; HOMA, homeostatic model assessment; CRP, C-Reactive Protein.