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

Research output: Contribution to journalArticle

49 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

Fingerprint

Alcoholic Hepatitis
Pentoxifylline
Prednisolone
Adrenal Cortex Hormones
Survival Rate
Confidence Intervals
Hepatorenal Syndrome
Therapeutics
Hepatitis
Hemorrhage
Survival
Mortality

Keywords

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

ASJC Scopus subject areas

  • Hepatology

Cite this

Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis : A randomised, non-inferiority, open trial. / Park, Seung Ha; Kim, Dong Joon; Kim, Young Seok; Yim, Hyung Joon; Tak, Won Young; Lee, Heon Ju; Sohn, Joo Hyun; Yoon, Ki Tae; Kim, In Hee; Kim, Hyoung Su; Um, Soon-Ho; Baik, Soon Koo; Lee, June Sung; Suk, Ki Tae; Kim, Sang Gyune; Suh, Sang Jun; Park, Soo Young; Kim, Tae Yeob; Jang, Jae Young.

In: Journal of Hepatology, Vol. 61, No. 4, 01.01.2014, p. 792-798.

Research output: Contribution to journalArticle

Park, SH, Kim, DJ, Kim, YS, Yim, HJ, Tak, WY, Lee, HJ, Sohn, JH, Yoon, KT, Kim, IH, Kim, HS, Um, S-H, Baik, SK, Lee, JS, Suk, KT, Kim, SG, Suh, SJ, Park, SY, Kim, TY & Jang, JY 2014, 'Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial', Journal of Hepatology, vol. 61, no. 4, pp. 792-798. https://doi.org/10.1016/j.jhep.2014.07.001
Park, Seung Ha ; Kim, Dong Joon ; Kim, Young Seok ; Yim, Hyung Joon ; Tak, Won Young ; Lee, Heon Ju ; Sohn, Joo Hyun ; Yoon, Ki Tae ; Kim, In Hee ; Kim, Hyoung Su ; Um, Soon-Ho ; Baik, Soon Koo ; Lee, June Sung ; Suk, Ki Tae ; Kim, Sang Gyune ; Suh, Sang Jun ; Park, Soo Young ; Kim, Tae Yeob ; Jang, Jae Young. / Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis : A randomised, non-inferiority, open trial. In: Journal of Hepatology. 2014 ; Vol. 61, No. 4. pp. 792-798.
@article{efd1624827ca433890ce13be2b8003ae,
title = "Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis: A randomised, non-inferiority, open trial",
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.",
keywords = "Alcoholic hepatitis, Corticosteroid, Non-inferiority trial, Pentoxifylline",
author = "Park, {Seung Ha} and Kim, {Dong Joon} and Kim, {Young Seok} and Yim, {Hyung Joon} and Tak, {Won Young} and Lee, {Heon Ju} and Sohn, {Joo Hyun} and Yoon, {Ki Tae} and Kim, {In Hee} and Kim, {Hyoung Su} and Soon-Ho Um and Baik, {Soon Koo} and Lee, {June Sung} and Suk, {Ki Tae} and Kim, {Sang Gyune} and Suh, {Sang Jun} and Park, {Soo Young} and Kim, {Tae Yeob} and Jang, {Jae Young}",
year = "2014",
month = "1",
day = "1",
doi = "10.1016/j.jhep.2014.07.001",
language = "English",
volume = "61",
pages = "792--798",
journal = "Journal of Hepatology",
issn = "0168-8278",
publisher = "Elsevier",
number = "4",

}

TY - JOUR

T1 - Pentoxifylline vs. corticosteroid to treat severe alcoholic hepatitis

T2 - A randomised, non-inferiority, open trial

AU - Park, Seung Ha

AU - Kim, Dong Joon

AU - Kim, Young Seok

AU - Yim, Hyung Joon

AU - Tak, Won Young

AU - Lee, Heon Ju

AU - Sohn, Joo Hyun

AU - Yoon, Ki Tae

AU - Kim, In Hee

AU - Kim, Hyoung Su

AU - Um, Soon-Ho

AU - Baik, Soon Koo

AU - Lee, June Sung

AU - Suk, Ki Tae

AU - Kim, Sang Gyune

AU - Suh, Sang Jun

AU - Park, Soo Young

AU - Kim, Tae Yeob

AU - Jang, Jae Young

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

KW - Alcoholic hepatitis

KW - Corticosteroid

KW - Non-inferiority trial

KW - Pentoxifylline

UR - http://www.scopus.com/inward/record.url?scp=84938912078&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84938912078&partnerID=8YFLogxK

U2 - 10.1016/j.jhep.2014.07.001

DO - 10.1016/j.jhep.2014.07.001

M3 - Article

VL - 61

SP - 792

EP - 798

JO - Journal of Hepatology

JF - Journal of Hepatology

SN - 0168-8278

IS - 4

ER -