Treatment with potentially hepatotoxic drugs and the risk of hepatocellular carcinoma: Results of a European case-control study

Some toxicological data and case reports have suggested that patients takin g potentially hepatotoxic drugs may have an increased risk of benign and ma lignant liver tumours. Pharmacoepidemiological studies on this issue are sp arse, most of them focusing on the association between hepatocellular carci noma (HCC) and the use of oral contraceptives (OC). The objectives of our s tudy were to examine the risk of HCC in patients taking the drugs mentioned in these case reports and toxicological studies. We used data from an inte rnational case-control study which had investigated the risk of HCC in wome n taking OC including 317 cases of HCC and 1060 frequency age-matched hospi tal controls. We investigated the risk for oral antidiabetic and immunosupp ressive drugs, methyldopa, nitrofurantoin and clofibrate using unconditiona l logistic regression analysis. The analysis was adjusted for age, hepatiti s B, hepatitis C, alcohol abuse and other risk factors of HCC. The adjusted odds ratios for ever-use of the investigated drugs varied between 0.67 and 1.64, none of them being statistically significant. There was equally no s ignificantly increased risk for long-term use of these drugs. Altogether th ere is no evidence for an increased risk of HCC in patients taking the drug s investigated, however, the relatively small statistical power for certain drugs with a low exposure prevalence has to be taken into account. Copyrig ht (C) 2000 John Wiley & Sons, Ltd.