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

Seung Ha Park, Dong Joon Kim, Young Seok Kim, Hyung Joon Yim, Won Young Tak, Heon Ju Lee, Joo Hyun Sohn, Ki Tae Yoon, In Hee Kim, Hyoung Su Kim, Soon-Ho Um, Soon Koo Baik, June Sung Lee, Ki Tae Suk, Sang Gyune Kim, Sang Jun Suh, Soo Young Park, Tae Yeob Kim, Jae Young Jang

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51 Citations (Scopus)

Abstract

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 noninferiority trial, we assigned 121 patients with severe alcoholic hepatitis (Maddrey's discriminant functionP32) 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 (D15%) 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.

Original languageEnglish
Pages (from-to)792-798
Number of pages7
JournalJournal of Hepatology
Volume61
Issue number4
DOIs
Publication statusPublished - 2014 Jan 1

Keywords

  • Alcoholic hepatitis
  • Corticosteroid
  • Non-inferiority trial
  • Pentoxifylline

ASJC Scopus subject areas

  • Hepatology

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    Park, S. H., Kim, D. J., Kim, Y. S., Yim, H. J., Tak, W. Y., Lee, H. J., Sohn, J. H., Yoon, K. T., Kim, I. H., Kim, H. S., Um, S-H., Baik, S. K., Lee, J. S., Suk, K. T., Kim, S. G., Suh, S. J., Park, S. Y., Kim, T. Y., & Jang, J. Y. (2014). Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial. Journal of Hepatology, 61(4), 792-798. https://doi.org/10.1016/j.jhep.2014.07.001