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Cited 58 time in webofscience Cited 61 time in scopus
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Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial

Authors
Park, Seung HaKim, Dong JoonKim, Young SeokYim, Hyung JoonTak, Won YoungLee, Heon JuSohn, Joo HyunYoon, Ki TaeKim, In HeeKim, Hyoung SuUm, Soon HoBaik, Soon KooLee, June SungSuk, Ki TaeKim, Sang GyuneSuh, Sang JunPark, Soo YoungKim, Tae YeobJang, Jae Young
Issue Date
Oct-2014
Publisher
ELSEVIER SCIENCE BV
Keywords
Alcoholic hepatitis; Corticosteroid; Pentoxifylline; Non-inferiority trial
Citation
JOURNAL OF HEPATOLOGY, v.61, no.4, pp 792 - 798
Pages
7
Indexed
SCI
SCIE
SCOPUS
Journal Title
JOURNAL OF HEPATOLOGY
Volume
61
Number
4
Start Page
792
End Page
798
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/8870
DOI
10.1016/j.jhep.2014.05.014
ISSN
0168-8278
1600-0641
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 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 (Delta 15%) 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. (C) 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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Yim, Hyung Joon
Ansan Hospital (Department of Gastroenterology and Hepatology, Ansan Hospital)
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