Table 1.

Demographic and Selected Clinical Features for the African-American and Caucasians with definite, highly likely, or probable Drug-Induced Liver Injury

	African-Americans (n=144)	Caucasians (n=841)	P value
Age (years, mean [SD])	46.9 ± 15.7	50.7 ± 17	0.005
Females (%)	63	57	0.17
High School or Higher Education (%)	83	93	<0.001
Health Insurance (%)	88	95	0.005
BMI (kg/m2, mean [SD])	29.9 ± 7.6	27.3 ± 6.6	<0.001
Prior drug allergies (%)	38	49	0.02
Alcohol Use (%)	32	55	<0.001
Preexisting Liver Disease (%)	12	9	0.20
Diabetes mellitus (%)	31	22	0.03
Latency (days in median, IQR)	49 (24, 103)	42 (22, 99)	0.60
Days from earliest sign to primary implicated drug stop (days in median, IQR)	2 (0.5, 5.5)	3 (0, 12)	0.40
Severe skin reactions (%)	2.1	0.4	0.04
Jaundice (%)	69	69	0.9
Liver Test Results – Onset
ALT (U/L, mean [SD])	835 ± 893	773 ± 1095	0.10
Alk P (U/L, mean [SD])	262 ± 199	292 ± 261	0.50
Total bilirubin (mg/dL, mean [SD])	7.5 ± 7.2	6.4 ± 6.3	0.30
INR	1.4 ± 0.8	1.4 ± 1.0	0.19
Liver Test Results – Peak values
ALT (U/L, mean [SD])	1117 ± 1126	930 ± 1180	0.01
Alk P (U/L, mean [SD])	409 ± 383	403 ± 373	0.70
Total bilirubin (mg/dL, mean [SD])	14.2 ± 11.5	12.7 ± 11.6	0.06
INR	1.9 ± 1.8	1.6 ± 1.5	<0.001
Eosinophilia (>500/μL) (%)	13.4	11.6	0.56
Improvement in liver tests (median days)
Peak ALT to below ULN	66	62	0.40
Peak Alk P to below ULN	142	77	0.06
Peak bilirubin to ≤ 2.5 mg/dL	36	33	0.14
R-ratio (mean, SD)	12 ± 14	12 ± 26	0.14
Pattern of Liver Injury (%)
Hepatocellular	61	51	0.08
Cholestatic	22	25
Mixed	17	24

Abbreviations: 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%); ULN, upper limit of normal