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Prednisolone Alone for Severe Alcoholic Hepatitis

September 10, 2013

Prednisolone Alone for Severe Alcoholic Hepatitis

  1. Atif Zaman, MD, MPH

The addition of pentoxifylline did not improve 6-month survival.

  1. Atif Zaman, MD, MPH

Prednisolone or pentoxifylline (PTX) has been shown to improve outcomes in patients with severe alcoholic hepatitis. Prednisolone seems to inhibit proinflammatory cytokines, and PTX reduces the risk for hepatorenal syndrome. Now, investigators have assessed whether a combination of both agents is more efficacious than prednisolone alone.

In a multicenter, double-blind study in Europe, researchers randomized 270 patients who were heavy drinkers with severe (Maddrey score, ≥32), biopsy-proven alcoholic hepatitis to receive prednisolone (40 mg daily) plus PTX (400 mg 3 times daily) or prednisolone plus placebo for 28 days.

Six-month survival (primary outcome) was similar between the combination group and the prednisolone-alone group (69.9% vs. 69.2%; P=0.91). The 7-day therapeutic response was similar between groups, as measured by the Lille score (P=0.80). The probability of being a responder and the incidence of hepatorenal syndrome were also similar between groups (P=0.91 and P=0.07, respectively).

Comment

In this adequately powered, well-executed study, the addition of pentoxifylline to prednisolone therapy for the treatment of severe alcoholic hepatitis did not improve survival. The survival rate of 69% in both groups is similar to previous findings for each therapy alone and lends credence to the negative results of this study. Additional therapies need to be explored in order to identify more-effective regimens in treating this disease, which kills 3 out of 10 patients within 6 months of treatment initiation.

  • Disclosures for Atif Zaman, MD, MPH at time of publication Speaker’s bureau Bristol-Myers Squibb; Genentech; Gilead; Kadmon; Merck; Salix; Vertex

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