Table 2.
Comparison of baseline demographic and clinical characteristics between high causality DILI cases in pregnancy and non-pregnant DILI case controls.
| CHARACTERISTICS | PREGNANT (n=16) | NON-PREGNANT (n=309) | P-VALUE |
|---|---|---|---|
| DEMOGRAPHICS | |||
|
| |||
| Age, median (IQR) | 28.8 (26.1, 31.9) | 35.9 (27.4, 41.8) | 0.02 |
| Race, n (%) | 0.05 | ||
| White or Caucasian | 7 (43.8%) | 220 (71%) | |
| Black or AA | 6 (37.5%) | 54 (17.5%) | |
| Asian | 0 (0.0) | 9 (2.9%) | |
| Other/Multiracial | 3 (18.8%) | 25 (8.1%) | |
| Ethnicity, Latino, n (%) | 3 (18.8%) | 49 (15.9%) | 0.75 |
| BMI, median (IQR) | 32.5 (23.6, 39.0) | 26.1 (22.7,31.6) | 0.05 |
|
| |||
| CLINICAL CHARACTERISTICS | |||
|
| |||
| Pre-existing Liver Disease, n (%) | 0 | 6 (1.9%) | >0.99 |
| Hepatitis C | 0 | 6 (1.9%) | >0.99 |
| NAFLD | 0 | 6 (1.9%) | >0.99 |
| Other | |||
|
| |||
| CLINICAL EVALUATION AT PRESENTATION | |||
|
| |||
| ADJUDICATED DRUGS, n (%) | |||
| Antimicrobial | 2 (12.5%) | 142 (46.0%) | 0.009 |
| Cardiovascular | 9 (56.3%) | 13 (4.2%) | <0.001 |
| Methyldopa | 9 (56.3%) | 3 (0.8%) | <0.001 |
| Endocrine | 2 (4.5%) | 14 (4.5%) | 0.18 |
| CNS | 1 (6.3%) | 47 (15.2%) | 0.48 |
| Antineoplastic | 1 (6.3%) | 21 (6.8%) | >0.99 |
| Other | 1 (6.3%) | 72 (23.3%) | 0.01 |
| Laboratory Test Results, median (IQR) or n (%) | |||
| ALT (U/L) | 1174 (670, 1364) | 519 (245,1132) | 0.01 |
| AST (U/L) | 1511 (461, 1890) | 400 (155, 1035) | 0.01 |
| TB (mg/dL) | 6.6 (2.3, 15.6) | 3.4 (0.8, 7.7) | 0.12 |
| AP (U/L) | 161.5 (125, 191) | 177.0 (117, 262) | 0.41 |
| ANA positive | 6 (46.2%) | 93 (32.4%) | 0.36 |
| ASMA positive | 4 (30.8%) | 58 (21.6%) | 0.49 |
| Eosinophilia (>500/uL) | 1 (6.7%) | 44 (15.2%) | 0.71 |
| MELD score (IQR) | 17 (12, 20) | 15 (9, 20) | 0.62 |
| INR | 1.2 (1.1,1.5) | 1.2 (1.0,1.7) | 0.92 |
| Serum IgG (mg/dL) | 1300 (1015-1987) | 1221 (944-1645) | 0.53 |
| Liver Injury Pattern, n (%) | |||
| Hepatocellular | 14 (87.5%) | 190 (64%) | 0.22 |
| Mixed | 1 (6.3%) | 52 (17.5%) | |
| Cholestatic | 1 (6.3%) | 55 (18.5%) | |
| R-value, median (IQR) | 17.6 (11.5, 26.4) | 8.7 (2.8, 19.6) | 0.02 |
Abbreviations: AA, African American; NAFLD, nonalcoholic fatty liver disease; AP, alkaline phosphatase; ANA, antinuclear antibody; ASMA, anti-smooth muscle antibody; MELD, model for endstage liver disease; TB; total bilirubin; IgG, immunoglobulin G