Budesonide in Severe Alcoholic Hepatitis: Results of the Original Research

Abstract

Background and aim: Severe alcoholic hepatitis (AH) is a life-threatening alcoholic liver disease with a potential of 30-40% mortality at 1 month. While steroids remain to be a first line therapy, there is a need in alternative treatment. The aim of the study is to compare efficacy and safety of budesonide and prednisolone in treatment of severe AH and to determine predictors of none-response, predictors of short-term mortality. Methods: 37 patients with severe AH were randomized in 2 groups and enrolled in the prospective trial. Group 1 (n=17) patients received budesonide 9 mg/daily per os, group 2 (n=20) patients were managed with prednisolone 40 mg/daily per os. Treatment duration was 28 days. Response criteria – Lille model. Results: There were no significant differences in short-term survival (р = 0,857). In group 2 adverse events were statistically more frequently than in group 1 (70% vs. 26,7%, р = 0,011). Hepatorenal syndrome occurred more frequently in group 2 (р = 0,033). Predictors of non-response were MELD score (р = 0,009), ABIC score (р = 0,011), hepatic encephalopathy (p=0,035), total bilirubin (p=0,016). Predictors of mortality were Lille score (p=0,018), serum glucose (p=0,017), total bilirubin level at the 7th day of the therapy (p=0,030). Conclusions: Budesonide therapy for patients with severe alcoholic hepatitis showed same efficacy as prednisolone treatment with significantly less adverse events. Budesonide appears to be effective in prevention of hepatorenal syndrome.