Table 1.
Characteristics of patients with persistent vs resolved liver injury at 12 months after DILI onset.
| Characteristic | Month 12 persisters N=74 |
Month 12 resolvers N=25 |
P-value ^ |
|---|---|---|---|
| Age (yrs) | 52.6 ± 14.0 | 43.7 ± 17.3 | 0.01 |
| Female (%) | 69% | 68% | 1.00 |
| Race (%) | 1.00 | ||
| Caucasian | 74% | 76% | |
| Black | 18% | 20% | |
| Asian | 5% | 4% | |
| Others | 3% | 0% | |
| Hispanic (%) | 5% | 8% | 0.64 |
| BMI (kg/m2) | 27.5 ± 6.4 | 28.1 ± 9.2 | 0.77 |
| Self-reported drug allergies (%) | 49% | 28% | 0.10 |
| Medical History | |||
| Diabetes mellitus (%) | 34% | 24% | 0.46 |
| Heart disease (%) | 35% | 4% | < 0.01 |
| Any alcohol prior to DILI onset (%) a | 40% | 68% | 0.02 |
| Amongst drinkers b | |||
| Heavy alcohol use (%) | 17% | 23% | 0.70 |
| Implicated agents | |||
| Duration of agent use (days) | 54 (1, 2343) | 32 (1, 2120) | 0.70 |
| Single drug (%) | 50% | 56% | 0.23 |
| Single HDS (%) | 4% | 12% | |
| Multiple drug(s) /or HDS (%) | 46% | 32% | |
| Primary implicated agent class | 0.88 | ||
| Antimicrobial (%) | 38% | 36% | 1.00 |
| Antineoplastic (%) | 13% | 12% | 1.00 |
| Cardiovascular (%) | 15% | 8% | 0.51 |
| HDS (%) | 8% | 24% | 0.07 |
| Endocrine (%) | 7% | 0% | 0.33 |
| 7% | 0% | 0.33 | |
| Gastrointestinal (%) | 3% | 8% | 0.26 |
| Analgesic (%) | 3% | 8% | 0.26 |
| CNS (%) | 3% | 0% | 1.00 |
| Immunolomodulatory (%) | 4% | 4% | 1.00 |
| Liver biochemistries at DILI onset | |||
| Serum AST (U/L) | 266 (29, 2125) | 367 (45, 2077) | 0.07 |
| Serum ALT (U/L) | 275 (14, 2733) | 553 (121, 2412) | 0.01 |
| Alk P (U/L) | 394 (41, 1730) | 219 (74, 783) | <.01 |
| Total bilirubin (mg/dl) | 5.2 (0.2, 29.7) | 7.2 (0.2, 36.2) | 0.24 |
| 1.2 (0.9, 3.5) | 1.1 (0.9, 3.2) | 0.48 | |
| INR | |||
| Albumin (g/dL) | 3.5 (1.7, 4.6) | 3.7 (2.3, 4.4) | 0.29 |
| MELD score | 16.5 (6.0, 40.0) | 18.0 (6.0, 40.0) | 0.65 |
| R-value | 1.8 (0.1, 70.2) | 8.0 (1.0, 27.8) | <.01 |
| Pattern of Injury | |||
| Cholestatic (%) | 54% | 20% | <.01 |
| Mixed (%) | 18% | 20% | |
| Hepatocellular (%) | 28% | 60% | |
| Causality score (%) | 0.49 | ||
| Definite | 15% | 16% | |
| Very likely | 53% | 64% | |
| Probable | 32% | 20% | |
| Corticosteroid use (%) | 47% | 44% | 1.00 |
| Ursodeoxycholic acid use (%) | 26% | 12% | 0.18 |
| Peak liver biochemistries within 6 months of DILI onset | |||
| Serum AST (U/L) | 354 (57, 3229) | 462 (116, 2343) | 0.33 |
| Serum ALT (U/L) | 428 (62, 3742) | 630 (133, 2412) | 0.05 |
| Alk P (U/L) | 599 (65, 2865) | 246 (90, 1016) | <.01 |
| Total bilirubin (mg/dl) | 13.8 (0.5, 54.8) | 10.8 (0.4, 38.2) | 0.66 |
| INR | 1.2 (0.9, 13.1) | 1.2 (0.9, 3.2) | 0.22 |
| Lowest Albumin (g/dL | 2.7 (0.6, 4.9) | 3.3 (1.3, 4.2) | 0.04 |
Data reported as mean ± standard deviation or median (range)
^
Month 12 persisters vs resolvers
a
% with any alcohol use prior to DILI onset
b
Determined from Skinner Survey in 5 years prior to DILI onset.
Heavy alcohol use defined as > 21 drinks/ week in men and > 14 drinks/week in women