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

Title
Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial
Author(s)
이헌주박성하[박성하]원영택[원영택]김영석[김영석]박수영[박수영]김형수[김형수]김동준[김동준]서상준[서상준]장재영[장재영]백순구[백순구]
Keywords
SHORT-TERM SURVIVAL; LIVER-DISEASE; CLINICAL-TRIALS; DOUBLE-BLIND; PREDNISOLONE; THERAPY; GLUCOCORTICOIDS; METAANALYSIS; MANAGEMENT; STEROIDS
Issue Date
201410
Publisher
ELSEVIER SCIENCE BV
Citation
JOURNAL OF HEPATOLOGY, v.61, no.4, pp.792 - 798
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.
URI
http://hdl.handle.net/YU.REPOSITORY/30667http://dx.doi.org/10.1016/j.jhep.2014.05.014
ISSN
0168-8278
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의과대학 > 내과학교실 > Articles
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