Dati preliminari dello studio multicentrico caso-controllo "Grave danno epatico acuto indotto da farmaci"

Drug-induced liver injury (DILI) is a term that describes abnormalities in liver function tests related to medication intake. Acetaminophen is the most common cause of DILI followed by antibiotics, NSAIDs, and antitubercular medications. NSAIDs represent one of the most widely used classes of drugs. Numerous case reports have described patients who develop fatal liver injury while taking NSAIDs. Several NSAIDs were withdrawn from the market because of hepatic ADRs. The latest warning signal for hepatotoxicity induced by a NSAID is related to nimesulide. In some European countries, Finland, Spain, and Ireland, nimesulide was suspended from the market because of an associated high frequency of hepatotoxicity. In contrast, a recent referral of the EMEA concluded that the benefits of the drug outweigh its risks. However, the full extent of the risk of nimesulide-induced liver injury is still a much debated issue within the EMEA. Primary objectives was to estimate the relative risk of liver injury induced by drugs with a prevalence of use in the Italian population > or = 6% This study is designed as a multicenter case†"control study where cases and controls will all be recruited among patients seen in a hospital context in various parts of Italy. Information regarding demographic data, medical history, coexisting illnesses, lifestyles and dietary habits, alcohol, tobacco and coffee intake, use of herbal products, and drug use (including doses taken and indication for use on each day of exposure) will be collected directly from all patients through a structured interview. Preliminary results of this study confirm a significant relative risk (Odds Ratio) of liver injury associated with the use of nimesulide, NSAIDs, some antibiotics like macrolides and paracetamol. The results of this study could strongly affect regulatory decisions within the National Health Service.