In patients with severe alcohol-related hepatitis, does the addition of prophylactic amoxicillin-clavulanate to steroids reduce the risk of death compared with steroids alone?
The addition of prophylactic amoxicillin-clavulanate to steroids does not decrease mortality in patients hospitalized with severe alcohol-related hepatitis compared with steroids alone.
Plan de l'etude:
Randomized controlled trial (double-blinded)
Inpatient (any location) with outpatient follow-up
Severe alcohol-related hepatitis is associated with a high risk of mortality. In this multicenter trial from France and Belgium, the authors recruited patients with biopsy-confirmed, severe alcohol-related hepatitis (Maddrey function score of 32 or more, Model for End-stage Liver Disease [MELD] score of 21 or more) to receive either amoxicillin-clavulanate 1g-125mg three times daily for 30 days (n = 145) or a matching placebo (n = 147). Both groups also received oral prednisolone 40 mg daily for 30 days. Patients in the 2 groups were similar at baseline, with a mean age of 52 years and similar Maddrey and MELD scores. Overall, the combination of prophylactic amoxicillin-clavulanate plus prednisolone did not significantly improve survival at 60 days as compared with prednisolone alone (17.3% vs 21.9%; P = .33). Although the addition of the antibiotic decreased infection at 60 days (29.7% vs 41.5%; P = .02), it did not affect the incidence of hepatorenal syndrome at 60 days, or impact either 90-day or 180-day mortality. Further, there was no significant difference in the number of serious adverse events between the 2 groups.
Nita Shrikant Kulkarni, MD
Assistant Professor in Hospital Medicine