• 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, and Korean Association for the Study of the Liver (KASL)-Alcohol Related Problems Study Group.
• Department of Internal Medicine, Inje University Haeundae Paik-Hospital, Inje University College of Medicine, Busan, Republic of Korea.
• J. Hepatol. 2014 Oct 1;61(4):792-8.

Background & AimsBoth 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.MethodsIn 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.ResultsThe 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 = 5 9): 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.ConclusionsThe 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.Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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