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
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Article info
Publication history
Published online: May 15, 2014
Accepted:
May 6,
2014
Received in revised form:
April 27,
2014
Received:
December 12,
2013
See Editorial, pages 723–724Identification
Copyright
© 2014 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved.
