Table 1.
Baseline characteristics of all AlcHepNet OBS study participants
| Overall n=1109 | Subjects with AH n=709 | Heavy drinkers without AH n=246 | Healthy control n=154 | P-value | |
|---|---|---|---|---|---|
| Days of follow-up (median with IQR) | 135.0 (19.0, 229.0) | 135.0 (30.0, 219.0) | 219.0 (151.0, 252.0) | 0.0 (0.0, 0.0) | <.001 |
| Age at OBS enrollment | 44.7 ± 12.3 | 45.0 ± 10.7 | 48.8 ± 13.4 | 36.6 ± 13.4 | <.001 |
| Gender assigned at birth | <.001 | ||||
| Female | 491 (44.4%) | 289 (40.9%) | 105 (42.7%) | 97 (63.0%) | |
| Male | 616 (55.6%) | 418 (59.1%) | 141 (57.3%) | 57 (37.0%) | |
| Race | <.001 | ||||
| Non-white | 212 (19.6%) | 97 (14.0%) | 69 (28.3%) | 46 (31.7%) | |
| White | 868 (80.4%) | 594 (86.0%) | 175 (71.7%) | 99 (68.3%) | |
| BMI (mean) | 28.9 ± 7.3 | 29.6 ± 7.6 | 28.3 ± 7.2 | 26.5 ± 5.6 | <.001 |
| BMI (median) | 27.5 (23.8, 32.5) | 28.2 (24.4, 33.4) | 26.5 (23.6, 31.2) | 25.2 (22.7, 29.8) | <.001 |
| BMI Category | <.001 | ||||
| Normal weight BMI<25 | 327 (32.4%) | 180 (27.9%) | 81 (36.3%) | 66 (47.5%) | |
| Overweight 25<=BMI<30 | 322 (31.9%) | 200 (31.0%) | 80 (35.9%) | 42 (30.2%) | |
| Obese BMI>=30 | 359 (35.6%) | 266 (41.2%) | 62 (27.8%) | 31 (22.3%) | |
| Waist circumference (at the umbilicus) | 101.7 ± 18.1 | 107.8 ± 16.8 | 99.4 ± 16.8 | 89.0 ± 15.5 | <.001 |
| Waist circumference (at largest diameter) | 103.8 ± 18.0 | 109.3 ± 17.6 | 102.1 ± 16.1 | 92.0 ± 15.1 | <.001 |
| Hip circumference | 104.3 ± 15.6 | 105.0 ± 16.9 | 106.1 ± 14.6 | 100.4 ± 13.0 | 0.005 |
| Mid-upper arm circumference (between shoulder and elbow) | 28.3 ± 5.7 | 27.4 ± 5.7 | 30.1 ± 5.7 | 29.2 ± 5.1 | <.001 |
| Waist-Hip Ratio | 1.0 ± 0.1 | 1.0 ± 0.1 | 0.9 ± 0.1 | 0.9 ± 0.1 | <.001 |
| Education status | <.001 | ||||
| No college education | 359 (34.3%) | 269 (41.2%) | 83 (34.3%) | 7 (4.6%) | |
| College education | 689 (65.7%) | 384 (58.8%) | 159 (65.7%) | 146 (95.4%) | |
| Marital status | 0.044 | ||||
| Not married | 681 (62.9%) | 412 (60.1%) | 166 (68.0%) | 103 (67.3%) | |
| Married | 401 (37.1%) | 273 (39.9%) | 78 (32.0%) | 50 (32.7%) | |
| Study completion status | <.001 | ||||
| Did not complete | 519 (55.0%) | 409 (71.1%) | 110 (50.9%) | ||
| Completed | 425 (45.0%) | 166 (28.9%) | 106 (49.1%) | 153 (100.0%) | |
| Main reason for early discontinuation | <.001 | ||||
| No longer meets inclusion/exclusion criteria | 6 (1.2%) | 1 (0.2%) | 5 (4.5%) | ||
| Death | 176 (33.9%) | 173 (42.3%) | 3 (2.7%) | ||
| Liver Transplant | 80 (15.4%) | 80 (19.6%) | |||
| Other reason(s) | 30 (5.8%) | 19 (4.6%) | 11 (10.0%) | ||
| Patient lost to follow-up | 192 (37.0%) | 110 (26.9%) | 82 (74.5%) | ||
| Patient withdrew consent | 35 (6.7%) | 26 (6.4%) | 9 (8.2%) | ||
| Hospitalized due to alcoholic hepatitis within 1 year prior to baseline visit | <.001 | ||||
| No | 832 (76.3%) | 436 (62.9%) | 244 (99.6%) | 152 (100.0%) | |
| Yes | 258 (23.7%) | 257 (37.1%) | 1 (0.4%) | ||
| Age of first drink (mean ± SD) | 18.3 ± 6.1 | 18.6 ± 5.9 | 17.3 ± 7.3 | 18.9 ± 3.9 | 0.007 |
| Alcohol use at baseline | <.001 | ||||
| No | 207 (20.5%) | 123 (19.8%) | 7 (2.9%) | 77 (52.4%) | |
| Yes | 802 (79.5%) | 497 (80.2%) | 235 (97.1%) | 70 (47.6%) | |
| Steroid use | <.001 | ||||
| Never | 928 (83.7%) | 533 (75.2%) | 241 (98.0%) | 154 (100.0%) | |
| At least once | 181 (16.3%) | 176 (24.8%) | 5 (2.0%) | ||
| Liver biopsy data available | 0.004 | ||||
| No/Not done | 1090 (98.3%) | 690 (97.3%) | 246 (100.0%) | 154 (100.0%) | |
| Yes | 19 (1.7%) | 19 (2.7%) | |||
| History of cirrhosis | <.001 | ||||
| No | 1058 (95.4%) | 658 (92.8%) | 246 (100.0%) | 154 (100.0%) | |
| Yes | 51 (4.6%) | 51 (7.2%) | |||
| History of liver transplant | <.001 | ||||
| No | 1029 (92.8%) | 629 (88.7%) | 246 (100.0%) | 154 (100.0%) | |
| Yes | 80 (7.2%) | 80 (11.3%) | |||
| MELD Score (mean ± SD) | 19.8 ± 11.5 | 26.4 ± 8.3 | 6.9 ± 1.8 | 6.8 ± 1.3 | <.001 |
| Meld Score Classification | <.001 | ||||
| MELD score < 20 | 502 (47.7%) | 148 (21.2%) | 219 (100.0%) | 135 (100.0%) | |
| MELD score 20–25 | 220 (20.9%) | 220 (31.5%) | |||
| MELD score 26–30 | 135 (12.8%) | 135 (19.3%) | |||
| MELD score >30 | 195 (18.5%) | 195 (27.9%) | |||
| Child-Pugh Score | 8.5 ± 2.8 | 10.3 ± 1.8 | 5.2 ± 0.5 | 5.0 ± 0.1 | <.001 |
| Maddrey’s Discriminant Function | 33.1 ± 41.2 | 54.9 ± 35.7 | −7.1 ± 6.0 | −5.4 ± 4.8 | <.001 |
| APRI | 2.3 ± 3.1 | 3.3 ± 3.4 | 0.4 ± 1.1 | 0.3 ± 0.8 | <.001 |
| Estimated GFR (MDRD) | 79.5 ± 34.7 | 74.0 ± 39.7 | 88.0 ± 20.8 | 91.5 ± 19.1 | <.001 |
| Albumin | 3.3 ± 0.9 | 2.8 ± 0.6 | 4.1 ± 0.6 | 4.4 ± 0.4 | <.001 |
| Total Bilirubin | 11.4 ± 12.4 | 17.4 ± 11.7 | 0.6 ± 0.3 | 0.6 ± 0.4 | <.001 |
| Direct Bilirubin | 7.5 ± 8.9 | 12.1 ± 8.6 | 0.2 ± 0.1 | 0.3 ± 1.2 | <.001 |
| Creatinine | 1.3 ± 1.4 | 1.5 ± 1.7 | 0.9 ± 0.3 | 0.8 ± 0.2 | <.001 |
| ALT | 40.9 ± 41.5 | 48.7 ± 34.4 | 31.9 ± 62.0 | 19.3 ± 9.7 | <.001 |
| AST | 92.9 ± 81.1 | 127.8 ± 73.6 | 35.6 ± 62.9 | 20.4 ± 5.9 | <.001 |
| Alkaline Phosphatase | 142.0 ± 105.9 | 181.8 ± 112.0 | 75.5 ± 32.9 | 61.8 ± 18.3 | <.001 |
| Total Protein | 6.3 ± 1.0 | 5.8 ± 0.9 | 7.0 ± 0.7 | 7.2 ± 0.5 | <.001 |
| Hemoglobin | 10.8 ± 2.7 | 9.4 ± 1.8 | 13.3 ± 2.0 | 13.8 ± 1.6 | <.001 |
| Total WBC (x 10^9 /L) | 10.5 ± 7.5 | 12.8 ± 8.4 | 6.8 ± 2.3 | 5.9 ± 1.6 | <.001 |
| Platelet Count (10^9 /L) | 178.8 ± 98.9 | 136.9 ± 83.4 | 255.5 ± 88.9 | 249.4 ± 59.7 | <.001 |
| MCV | 96.9 ± 9.5 | 100.7 ± 8.8 | 91.7 ± 7.1 | 87.7 ± 5.2 | <.001 |
| INR | 1.6 ± 0.7 | 2.0 ± 0.6 | 1.0 ± 0.1 | 1.0 ± 0.1 | <.001 |
| PT | 18.1 ± 7.2 | 21.6 ± 6.7 | 11.4 ± 1.4 | 11.9 ± 1.5 | <.001 |
| MAP | 86.4 ± 12.8 | 83.0 ± 11.5 | 95.3 ± 13.2 | 88.2 ± 10.9 | <.001 |
| Status at 30 Days | <.001 | ||||
| Alive | 1018 (91.8%) | 618 (87.2%) | 246 (100.0%) | 154 (100.0%) | |
| Dead | 91 (8.2%) | 91 (12.8%) | |||
| Status at 90 Days | <.001 | ||||
| Alive | 963 (86.8%) | 566 (79.8%) | 243 (98.8%) | 154 (100.0%) | |
| Dead | 146 (13.2%) | 143 (20.2%) | 3 (1.2%) | ||
| Status at 180 Days | <.001 | ||||
| Alive | 939 (84.7%) | 542 (76.4%) | 243 (98.8%) | 154 (100.0%) | |
| Dead | 170 (15.3%) | 167 (23.6%) | 3 (1.2%) |
Note: Values expressed as n(%), mean±SD, or median (Q1,Q3). Abbreviations: AH: Alcoholic hepatitis; ALT: Alanine Aminotransferase; APRI: Aspartate Aminotransferase to Platelet Ratio Index; AST: Aspartate Aminotransferase; BMI: Body Mass Index; GFR: Glomerular Filtration Rate; INR: International Normalized Ratio; IQR: Interquartile Range; MAP: Mean Arterial Pressure; MDRD: Modification of Diet in Renal Disease; MCV: Mean Corpuscular Volume; MELD: Model for End-Stage Liver Disease; OBS: Observational; PT: Prothrombin Time; SD: Standard Deviation; WBC: White Blood Cell Count