Table 1.
Summary of Retrospective Drug-Induced Liver Injury (DILI) Studies
Reference | Setting | Time Period | Number of Patients | Number of Patients with Idiosyncratic DILI | DILI Frequency | Comments |
---|---|---|---|---|---|---|
de Valle et al (2006)13 | Swedish outpatient hepatology clinic | 1995–2005 | 1164 | 77 | 6.6% | DILI occurred more often in women (56%) Most common causative agents were antibiotics |
Hussaini et al (2007)14 | The Jaundice Hotline, a jaundice referral center in England | 1998–2004 | 347 | 28 | 8.1% | Most common causative agents were antibiotics |
Meier et al (2005)15 | Swiss SAS/CHDM inpatient pharmacoepidemiological database | 1996–2000 | 4209 | 57 | 1.4% | Most common causative agents were antineoplastic and antituberculosis medications in these hospitalized patients |
Russo et al (2004)16 | U.S. UNOS liver transplant database | 1990–2002 | 2291 | 137 | 6.0% | Numbers are for drug-induced liver transplants, which occurred more often in women (76%) Most common causative agents were isoniazid, propylthiouracil, phenytoin, and valproate Additional 133 patients had acetaminophen hepatotoxicity for total of 270 DILI cases (11.8% of liver transplants attributable to overall DILI) |
Vuppalanchi et al (2007)17 | Inner-city primary care clinics and nonreferral hospital in Indiana | 1999–2003 | 732 | 5 | 0.7% | Numbers are for drug-induced jaundice Drugs taken by patients in the DILI group included Metabolife, HAART, and valproate Additional 24 patients had acetaminophen hepatotoxicity for total of 29 DILI cases (4.0% of jaundice cases attributable to overall DILI) |
Jinjuvadia et al (2007)18 | ICD-9 codes and medication search of the UMHS database | 1994–2004 | 7395 | 83 | 1.1% | Patients were identified using ICD-9 liver injury codes, medication searches, and text searches of the dictated medical record Different searches yielded highly variable results Additional 36 patients had acetaminophen hepatotoxicity for total of 119 DILI cases (1.6% incidence rate of overall DILI) |
Duh et al (1999)19 | ICD-9 codes and medication search of the FCHP database in Massachusetts | 1992–1993 | 219 | 50 | 22.8% | Numbers are for drug-induced liver enzyme abnormalities Patients were identified using ICD-9 hepatic disorder codes and medication searches (only prescription drugs with hepatotoxicity warnings in the package insert were considered) Drug-induced liver enzyme abnormalities were the most common type of liver enzyme abnormalities (incidence rate of 41/100,000 persons per year) |
de Abajo et al (2004)20 | Population-based case-control study using data from the GPRD in the UK | 1994–1999 | 1,636,792 | 128 | 2.4/100,000 persons per year | Most common causative agents were chlorpromazine, azathioprine, and sulfasalazine |
DILI, drug-induced liver injury; SAS/CHDM, Stiftung für Arzneimittelsicherheit/Comprehensive Hospital Drug Monitoring; UNOS, United Network for Organ Sharing; HAART, highly active antiretroviral therapy; ICD-9, International Statistical Classification of Diseases; UMHS, University of Michigan Health System; FCHP, Fallon Community Health Plan; GPRD, General Practice Research Database.