Treatment of alcoholic hepatitis: is this a "dead-end"?

Abstract

Summary from the trial. All patients were followed for 12 months or until their death with the exception of patients enrolled at the end of the trial. Th e primary endpoint was mortality at 28 days and secondary endpoints included mortality or liver transplantation at 90 days and aft er 1 year. Neither drug showed mid- (90 days) or long-term (12 months) survival benefi t. However, prednisolone was associated with an improvement in 28-day mortality with an odds ratio of 0.72 (95%CI 0.52-1.01; P=0.06). In multivariate analysis, baseline age, encephalopathy, white cell count, prothrombin ratio and levels of bilirubin, creatinine and urea were found to be additional signifi cant factors for mortality. In a secondary analysis adjusting for these prognostic variables the odds ratio for 28-day mortality among the patients who received prednisolone compared with those who did not was 0.61 (95%CI 0.41-0.91; P=0.02). Serious adverse events were reported in 42% of the patients with approximately half of them resulting in death. No signifi cant diff erences in the rate of adverse events were noted between treatment groups. However, infection occurred more frequently in patients who received prednisolone compared with those who did not (13% vs. 7%, P=0.002). Of note, infections were the main reason for death in this trial (24% of deaths). Finally, pentoxifylline was associated with numerically fewer cases of acute kidney injury.