Table 3.
Summary of Prospective Studies of Drug-Induced Liver Injury
| Reference | Setting | Time Period | Number of Patients | Number of Patients with Idiosyncratic DILI | Frequency of DILI | Comments |
|---|---|---|---|---|---|---|
| Hartleb et al (2002)21 | Polish gastroenterology department | 1997–1999 | — | 14 | — | DILI occurred more often in women (57%) Most common causative agents were amoxicillin/clavulanic acid, lipid-lowering agents, and antituberculosis medications |
| Andrade et al (2005)22 | Spanish Registry of Hepatotoxicity | 1994–2004 | — | 461 | — | 109 cases were excluded due to unreliable chronological criteria or identification of alternative causes of liver injury Factors associated with worse outcomes were female sex, hepatocellular pattern of damage, and high bilirubin levels at baseline Most common causative agent was amoxicillin/clavulanic acid (12.8% of all DILI) |
| Ostapowicz et al (2002)1 | U.S. ALFSG | 1998–2001 | 308 | 40 | 13.0% | Numbers are for drug-induced ALF Additional 120 patients had acetaminophen hepatotoxicity for total of 160 DILI cases (51.9% of ALF attributable to overall DILI) |
| Larson et al (2005)10 | U.S. ALFSG | 1998–2003 | 662 | 79 | 12.0% | Numbers are for drug-induced ALF Additional 275 patients had acetaminophen hepatotoxicity for total of 354 DILI cases (53.5% of ALF attributable to overall DILI) |
| Chalasani et al (2008)23 | U.S. DILIN | 2004–2007 | — | 300 | — | DILI was caused by single prescription medication in 73%, dietary and herbal supplements in 9%, and multiple agents in 18% Most common causative agents were antimicrobials and central nervous system medications After 6-mo follow-up, 14% of patients had persistent laboratory abnormalities and 8% died |
| Sgro et al (2002)25 | French population- based study | 1997–2000 | 81,301 | 34 | 13.9 ± 2.4 cases/100,000 persons | Most common causative agents were antibiotics, psychotropics, lipid-lowering agents, and nonsteroidal anti- inflammatory drugs The number of hepatic ADRs would be 16 times greater than the number actually reported to French regulatory authorities 1 case of DILI was attributable to acetaminophen hepatotoxicity |
DILI, drug-induced liver injury; ALFSG, Acute Liver Failure Study Group; ALF, acute liver failure; DILIN, Drug-Induced Liver Injury Network; ADR, adverse drug reaction.