BibTex format
@article{Thursz:2015:10.3310/hta191020,
author = {Thursz, M and Forrest, E and Roderick, P and Day, C and Austin, A and O'Grady, J and Ryder, S and Allison, M and Gleeson, D and McCune, A and Patch, D and Wright, M and Masson, S and Richardson, P and Vale, L and Mellor, J and Stanton, L and Bowers, M and Ratcliffe, I and Downs, N and Kirkman, S and Homer, T and Ternent, L},
doi = {10.3310/hta191020},
journal = {Health Technology Assessment},
pages = {1--+},
title = {The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2 x 2 factorial randomised controlled trial},
url = {http://dx.doi.org/10.3310/hta191020},
volume = {19},
year = {2015}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - Background:Alcoholic hepatitis (AH) is a distinct presentation of alcoholic liver disease arising in patients who have been drinking to excess for prolonged periods, which is characterised by jaundice and liver failure. Severe disease is associated with high short-term mortality. Prednisolone and pentoxifylline (PTX) are recommended in guidelines for treatment of severe AH, but trials supporting their use have given heterogeneous results and controversy persists about their benefit.Objectives:The aim of the clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis trial was to resolve the clinical dilemma on the use of prednisolone or PTX.Design:The trial was a randomised, double-blind, 2 × 2 factorial, multicentre design.Setting:Sixty-five gastroenterology and hepatology inpatient units across the UK.Participants:Patients with a clinical diagnosis of AH who had a Maddrey’s discriminant function value of ≥ 32 were randomised into four arms: A, placebo/placebo; B, placebo/prednisolone; C, PTX/placebo; and D, PTX/prednisolone. Of the 5234 patients screened for the trial, 1103 were randomised and after withdrawals, 1053 were available for primary end-point analysis.Interventions:Those allocated to prednisolone were given 40 mg daily for 28 days and those allocated to PTX were given 400 mg three times per day for 28 days.Outcomes:The primary outcome measure was mortality at 28 days. Secondary outcome measures included mortality or liver transplant at 90 days and at 1 year. Rates of recidivism among survivors and the impact of recidivism on mortality were assessed.Results:At 28 days, in arm A, 45 of 269 (16.7%) patients died; in arm B, 38 of 266 (14.3%) died; in arm C, 50 of 258 (19.4%) died; and in arm D, 35 of 260 (13.5%) died. For PTX, the odds ratio for 28-day mortality was 1.07 [95% confidence interval (CI) 0.77 to 1.40; p = 0.686)] and for prednisolone the odds
AU - Thursz,M
AU - Forrest,E
AU - Roderick,P
AU - Day,C
AU - Austin,A
AU - O'Grady,J
AU - Ryder,S
AU - Allison,M
AU - Gleeson,D
AU - McCune,A
AU - Patch,D
AU - Wright,M
AU - Masson,S
AU - Richardson,P
AU - Vale,L
AU - Mellor,J
AU - Stanton,L
AU - Bowers,M
AU - Ratcliffe,I
AU - Downs,N
AU - Kirkman,S
AU - Homer,T
AU - Ternent,L
DO - 10.3310/hta191020
EP - 1
PY - 2015///
SN - 1366-5278
SP - 1
TI - The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2 x 2 factorial randomised controlled trial
T2 - Health Technology Assessment
UR - http://dx.doi.org/10.3310/hta191020
UR - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000367344600001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
VL - 19
ER -