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. 2015 May 22;79(6):988–999. doi: 10.1111/bcp.12565

Table 3.

Selected demographic, clinical, and laboratory features of subjects with drug-induced liver injury

Characteristics ‘Outpatient’ cases Inpatient cases P value
n = 122 (%) n = 76 (%)
Gender, n (%)
- Male 44 (36) 40 (53)
- Female 78 (64) 36 (47) 0.03
Age (years) mean ± standard deviation 55.6 ± 17.2 55.0 ± 17.5 NS
Grading, n (%)
- hepatocellular 84 (68.9) 35 (46.1) <0.01
- cholestatic 11 (9) 15 (19.7) 0.0497
- mixed 24 (19.7) 15 (19.7) >0.05
- unclassifiable 3 (2.5) 11 (14.5) <0.01
Signs of hypersensitivity, n (%) 27 (22.1) 13 (17.1) NS
ALT/ULN, mean ± standard deviation 31.1 ± 28.2 15.8 ± 20.5 <0.001
AST/ULN, mean ± standard deviation 24.7 ± 30.9 13.6 ± 29.4 0.01
ALP/ULN, mean ± standard deviation 1.9 ± 1.4 2.6 ± 3.8 NS
Bilirubin total/ULN, mean ± standard deviation 7.4 ± 8.6 3.3 ± 5.1 <0.001
Hyperbilirubinaemia, n (%) 86 (70.5) 30 (39.5) <0.001
Coagulopathy§, n (%) 39 (32) 9 (11.8) <0.01
Serology testing
- Hepatitis A virus 104 (85.2) 55 (72.4)
- Hepatitis B virus 116 (95.1) 63 (82.9)
- Hepatitis C virus 113 (92.6) 59 (77.6)
- Cytomegalovirus 40 (32.8) 10 (13.2)
- EpsteinBarr virus 43 (35.2) 14 (18.4)
- Hepatitis E virus 17 (13.9) 1 (1.3)
- Herpes simplex virus 17 (13.9) 3 (3.9)
- Varicella zoster virus 12 (9.8) 3 (3.9)
Autoimmune antibodies testing 88 (72.1) 27 (35.5)
Abdominal sonography 121 (99.2) 70 (92.1)
Histology 62 (50.8) 13 (17.1)
Fatigue, n (%) 81 (66.4) 38 (50) 0.03
Jaundice, n (%) 54 (44.3) 19 (25) <0.01
Acholic faeces/dark urine, n (%) 41 (33.6) 12 (15.8) <0.01
Abdominal pain, n (%) 44 (36.1) 19 (25) NS
ALF, n (%) 6 (4.9) 1 (1.3) NS
- ALF requiring liver transplantation, n (%) 1 (0.8) 0 (0)
Hepatic encephalopathy, n (%) 6 (4.9) 3 (3.9) NS
Death, n (%) 4 (3.3) 4 (5.3) NS
- liver injury as certain cause of death, n (%) 1 (0.8) 1 (1.3)
Drug causality assessment
- ≥ 1 medication assessed as highly probable (CIOMS > 8) 7 (5.7) 4 (5.3)
- ≥ 1 medication assessed as probable (CIOMS 6–8) 55 (45.1) 25 (32.9)
- ≥ 1 medication assessed as possible (CIOMS 3–5 66 (54.1) 54 (71.1)
Challenge (time to onset)
- From the beginning of the drug: 5 days – 90 days 46 (40.0)** 52 (70.3)*
- From the beginning of the drug: < 5 days – > 90 days 69 (60.0)** 27 (36.5)*
- From drug cessation: < 15 days (<30 days in cholestatic / mixed cases) 16 (13.9)** 16 (21.6)*
Dechallenge
- Strongly positive dechallenge*** 49 (42.6)** 36 (48.6)*
- Slightly positive dechallenge**** 38 (33.0)** 27 (36.5)*
- No information / negative dechallenge***** 28 (24.3)** 11 (14.9)*
Comedication ascertainment
- No / no information 5 (4.1) 1 (1.3)
- Concomitant / incompatible time course 56 (45.9) 22 (28.9)
- Concomitant / compatible time course 10 (8.2) 7 (9.2)
- Concomitant / compatible time course / hepatotoxic 60 (49.2) 50 (65.8)
*

Based on n = 74 due to two cases without drug causality and thus without challenge or dechallenge.

**

Based on n = 115 due to seven cases without drug causality and thus without challenge or dechallenge.

***

ALT decrease ≥ 50% within 8 days (cases of hepatocellular DILI) or ALP decrease ≥ 50% within 180 days (cases of cholestatic/mixed DILI).

****

ALT decrease ≥ 50% within 9–30 days (cases of hepatocellular DILI) or ALP decrease ≤ 50% within 180 days (cases of cholestatic/mixed DILI).

*****

All other items from the updated CIOMS scale regarding dechallenge.

Fever, rash, lymphadenopathy, arthralgia, myalgia and/or eosinophilia.

Bilirubin > 18.8 μmol l−1.

§

International normalized ratio > 1.2 or prothrombin time < 70%. ¶Severe coagulopathy (international normalized ratio > 1.5 or prothrombin time < 40%) and hepatic encephalopathy. ALF, acute liver failure; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; NS, non-significant; ULN, upper limit of normal.