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Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial

      Background & Aims

      Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis. However, few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition.

      Methods

      In this multicentre, open-labelled, randomised non-inferiority trial, we assigned 121 patients with severe alcoholic hepatitis (Maddrey’s discriminant function ⩾32) to receive either pentoxifylline (400 mg, 3 times daily, in 62 subjects) or prednisolone (40 mg daily, in 59 subjects). The primary end point was non-inferiority in survival at the 1 month time point for the pentoxifylline treatment compared with prednisolone.

      Results

      The 1-month survival rate of patients receiving pentoxifylline was 75.8% (15 deaths) compared with 88.1% (7 deaths) in those, taking prednisolone, for a treatment difference of 12.3% (95% confidence interval, −4.2% to 28.7%; p = 0.08). The 95% confidence interval for the observed difference exceeded the predefined margin of non-inferiority (Δ15%) and included zero. The 6-month survival rate was not significantly different between the pentoxifylline and prednisolone groups (64.5% vs. 72.9%; p = 0.23). At 7 days, the response to therapy assessed by the Lille model was significantly lower in the prednisolone group (n = 58) than in the pentoxifylline group (n = 59): 0.35 vs. 0.50 (p = 0.012). Hepatitis complications, including hepatorenal syndrome and side effects, such as infection and gastrointestinal bleeding, were similar in the two groups.

      Conclusions

      The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone, supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis.

      Abbreviation:

      CI (confidence interval)

      Keywords

      Linked Article

      • Prednisolone vs. pentoxifylline for severe alcoholic hepatitis
        Journal of HepatologyVol. 61Issue 4
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          In this issue, the Journal of Hepatology is publishing a non-inferiority trial by a Korean group on severe alcoholic hepatitis addressing the question of the efficacy of pentoxifylline and corticosteroids. Although several studies have been performed in this field, this subject remains controversial. The European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) have published guidelines [1,2] stating that pentoxifylline and corticosteroids are effective in decreasing mortality in severe alcoholic hepatitis.
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