Table 1.
Baseline characteristics by treatment group
| Obeticholic Acid (n=40) | Placebo (n=38) | P-value | |
|---|---|---|---|
| Demographics | |||
| Age – yr | 53 (9) | 52 (13) | 0.71 |
| Male sex – no. (%) | 15 (38%) | 14 (37%) | 0.95 |
| White race – no. (%) | 35 (88%) | 32 (84%) | 0.68 |
| Hispanic ethnicity – no. (%) | 7 (18%) | 6 (16%) | 0.84 |
| Liver enzymes | |||
| Alanine aminotransferase – U/L | 80 (41) | 68 (33) | 0.14 |
| Aspartate aminotransferase – U/L | 57 (32) | 50 (25) | 0.30 |
| Alkaline phosphatase – U/L | 76 (25) | 76 (24) | 0.96 |
| γ-Glutamyltransferase – U/L | 80 (103) | 61 (46) | 0.28 |
| Total bilirubin – mg/dL | 0.7 (0.3) | 0.6 (0.3) | 0.35 |
| Lipids | |||
| Cholesterol | |||
| Total – mg/dL | 192 (42) | 194 (48) | 0.87 |
| High-density lipoprotein – mg/dL | 44 (13) | 44 (15) | 0.83 |
| Low-density lipoprotein – mg/dL | 110 (36) | 115 (40) | 0.57 |
| Trigylcerides – mg/dL | 193 (89) | 180 (17) | 0.57 |
| Metabolic factors | |||
| Fasting serum glucose – mg/dL | 117 (35) | 107 (28) | 0.16 |
| Insulin – umol/mL | 39 (56) | 21 (15) | 0.06 |
| HOMA–IR∥ – mg/dL × umol/mL / 405 | 12.4 (18.6) | 3.8 (6.0) | 0.04 |
| Hemoglobin A1c – % | 6.4 (1.1) | 6.3 (0.9) | 0.56 |
| Weight – kg | 97 (18) | 94 (15) | 0.41 |
| Body–mass index – kg/m2 | 34 (5) | 33 (5) | 0.19 |
| Waist circumference – cm | 113 (12) | 108 (11) | 0.07 |
| Waist to hip ratio | 0.97 (0.07) | 0.94 (0.07) | 0.04 |
| Systolic blood pressure – mmHg | 132 (15) | 133 (16) | 0.80 |
| Diastolic blood pressure – mmHg | 78 (10) | 79 (11) | 0.33 |
| Comorbidities | |||
| Hyperlipidemia¶ – no. (%) | 21 (52%) | 20 (53%) | 0.99 |
| Hypertension – no. (%) | 20 (50%) | 21 (55%) | 0.64 |
| Cardiovascular disease – no. (%) | 0 (0%) | 1 (3%) | 0.30 |
| Diabetes – no. (%) | 20 (50%) | 20 (53%) | 0.82 |
| Concomitant medications in the past 6 months | |||
| Antilipidemic – no. (%) | 19 (48%) | 15 (39%) | 0.48 |
| Cardiovascular/hypertensive – no. (%) | 24 (60%) | 27 (71%) | 0.30 |
| Antidiabetic – no. (%) | 22 (55%) | 21 (55%) | 0.98 |
| Metformin – no. (%) | 20 (50%) | 19 (50%) | 1.00 |
| Pioglitazone – no. (%) | 0 (0%) | 1 (3%) | 0.30 |
| Vitamin E – no. (%) | 7 (18%) | 12 (32%) | 0.15 |
| Aspirin – no. (%) | 10 (25%) | 12 (32%) | 0.52 |
| Liver histology findings | |||
| Definite steatohepatitis – no. (%) | 31 (78%) | 30 (79%) | 0.88 |
| Fibrosis – stage† | 1.9 (1.1) | 1.7 (1.1) | 0.59 |
| Total NAFLD activity score‡ | 5.1 (1.3) | 5.4 (1.4) | 0.29 |
| Hepatocellular ballooning – score | 1.4 (0.8) | 1.4 (0.7) | 0.91 |
| Steatosis – score | 1.9 (0.8) | 2.1 (0.8) | 0.32 |
| Lobular inflammation – score | 1.8 (0.7) | 1.9 (0.8) | 0.47 |
| Portal inflammation – score§ | 1.2 (0.6) | 1.2 (0.6) | 0.76 |
| MRI-PDFF - % | |||
| Mean (SD) | 18 (9) | 20 (10) | 0.41 |
| Median [IQR] | 19 [10, 23] | 17 [12, 25] |
*
Plus–minus values are means±SD.
¶
High cholesterol or high triglyerides
†
Fibrosis was assessed on a scale of 0 to 4, with higher scores indicating more severe fibrosis.
‡
Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure are steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2).
§
Portal inflammation was assessed on a scale of 0 to 2 with higher scores indicating more severe inflammation.
∥
Homeostasis Model Assessment-estimated Insulin Resistance