At a glance
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Evaluation of the Survival Benefit of the Adjunction of Pentoxifylline to Corticosteroids in Patients Suffering From Severe Alcoholic Hepatitis
In Brief
A Phase 3 clinical trial evaluating Pentoxifylline and placebo for Alcoholic Hepatitis and Alcoholic Liver Disease. Completed, enrolled 278 participants across 28 sites in 2 countries.
Detailed Summary
The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.
Study Details
Timeline
Interventions
400 mg prolonged-released tablets 3 time per day for 1 month.
prolonged-release tablets 3 time per day for 1 month