Table 4.
Selected characteristics among the elderly (≥65yo), compared to younger subjects (≤65yo)
| ≥ 65 years (n=149) |
< 65 years (n=750) |
P value | |
|---|---|---|---|
| Age (years, mean [SD]) | 73 [6] | 44 [14] | |
| Females (%) | 60 | 59 | 0.8 |
| Self-reported race (%) | 0.12 | ||
| White | 85 | 77 | |
| Black or African-American | 7 | 13 | |
| Other/Multiracial | 8 | 10 | |
| BMI (kg/m2, mean [SD]) | 27 [5] | 28 [6.8] | 0.4 |
| Prior drug allergies (%) | 54 | 42 | 0.015 |
| Preexisting Liver Disease (%) | 10.1 | 9.9 | 0.9 |
| Concomitant medicines (%) | |||
| 0–2 / 3–5 / >5 | 16/26/58 | 26/26/48 | 0.03 |
| Diabetes mellitus (%) | 30 | 24 | 0.1 |
| Top 5 implicated classes of agents (%) | Antimicrobials (57.7%) | Antimicrobials (43%) | <0.001 |
| Cardiovascular (14.8%) | HDS (17.7%) | ||
| HDS (8.1%) | CNS agents (10.4%) | ||
| Antineoplastic (4%) | Cardiovascular (8.8%) | ||
| Analgesics (3.4%) | Antineoplastic (5.7%) | ||
| Latency (days in median , IQR) | 35 [18–99] | 36 [19–84] | 0.8 |
| Jaundice (%) | 67 | 71 | 0.4 |
| Pattern of liver injury | |||
| HC/Chol/Mixed (%) | 39/36/25 | 57/21/22 | <0.001 |
| Liver Biochemistries –DILI recognition | |||
| ALT (U/L, mean [SD]) | 619.5 [860.5] | 866± [1143.5] | 0.007 |
| AP (U/L, mean [SD]) | 410 [361] | 264 [220] | <0.001 |
| Total bilirubin (mg/dl, mean [SD]) | 7.0 [6.7] | 6.6 [6.6] | 0.4 |
| INR | 1.6 [1.2] | 1.4 [0.9] | 0.9 |
| Hy’s law (%) | 18 | 32 | 0.001 |
| Liver Biochemistries – Peak values | |||
| ALT (U/L, mean [SD]) | 757 [911] | 1057 [1268] | 0.002 |
| AP (U/L, mean [SD]) | 520 [446] | 383 [372] | <0.001 |
| Total bilirubin (mg/dl, mean [SD]) | 14 [12] | 13 [12] | 0.4 |
| INR | 1.8 [1.65] | 1.7 [1.5] | 0.9 |
| Peripheral eosinophilia (>500/µL) (%) | 11 | 11 | 1.0 |
| Improvement in biochemistries – days in | |||
| median | |||
| - Peak ALT to below ULN | 62 | 74 | 0.5 |
| - Peal AP to below ULN | 106 | 90 | 0.5 |
| - Peak bilirubin to ≤ 1 mg/dL | 78 | 68 | 0.8 |
| Causality Assessment (%) | |||
| Definite/ Highly likely/ Probable | 25.5/55/19.5 | 26/51/23 | 0.6 |
| Severity of Liver Injury (%) | |||
| Mild | 31 | 22 | 0.08 |
| Moderate | 19.5 | 22 | |
| Moderate-hospitalized | 29 | 29.5 | |
| Severe | 13 | 20 | |
| Fatal | 8 | 6.7 | |
| Death, at any time point (%) | 8.7 | 5.7 | 0.2 |
| - Proportion of Liver –related (%) | 54 | 48 | 0.8 |
| Liver Transplantation (%) | 2 | 4.4 | 0.25 |
| Chronic DILI (%) | 11.4 | 18.7 | 0.04 |
Abbreviations used: ALT, serum alanine aminotransferase; AP, serum alkaline phosphatase; BMI, body mass index; Chol, cholestatic; DILI, drug-induced liver injury; HC, hepatocellular; INR, international normalized ratio; IQR, interquartile range (25–75%); SD, standard deviation; ULN, upper limit of normal