• Mark R Thursz, Paul Richardson, Michael Allison, Andrew Austin, Megan Bowers, Christopher P Day, Nichola Downs, Dermot Gleeson, Alastair MacGilchrist, Allister Grant, Steven Hood, Steven Masson, Anne McCune, Jane Mellor, John O'Grady, David Patch, Ian Ratcliffe, Paul Roderick, Louise Stanton, Nikhil Vergis, Mark Wright, Stephen Ryder, Ewan H Forrest, and STOPAH Trial.
• From Imperial College (M.R.T., N.V.), King's College Hospital (J.O.), and the Royal Free Hospital (D.P.), London, Royal Liverpool Hospital (P. Richardson) and Aintree Hospital (S.H.), Liverpool, Addenbrookes Hospital, Cambridge (M.A.), Derby Royal Hospital, Derby (A.A.), Southampton Clinical Trials Unit, University of Southampton (M.B., N.D., J.M., I.R., P. Roderick, L.S.), and University Hospital Southampton NHS Foundation Trust (M.W.), Southampton, Faculty of Medical Sciences, Newcastle University (C.P.D.), and Newcastle upon Tyne Hospitals NHS Foundation Trust (S.M.), Newcastle upon Tyne, Sheffield Teaching Hospitals Foundation Trust, Sheffield (D.G.), Edinburgh Royal Infirmary, Edinburgh (A. MacGilchrist), Leicester Royal Infirmary, Leicester (A.G.), Bristol Royal Infirmary, Bristol (A. McCune), Nottingham University Hospitals NHS Trust and National Institute for Health Research Biomedical Research Unit, Queens Medical Centre, Nottingham (S.R.), and the Glasgow Royal Infirmary, Glasgow (E.H.F.) - all in the United Kingdom.
• N. Engl. J. Med. 2015 Apr 23; 372 (17): 161916281619-28.

BackgroundAlcoholic hepatitis is a clinical syndrome characterized by jaundice and liver impairment that occurs in patients with a history of heavy and prolonged alcohol use. The short-term mortality among patients with severe disease exceeds 30%. Prednisolone and pentoxifylline are both recommended for the treatment of severe alcoholic hepatitis, but uncertainty about their benefit persists.MethodsWe conducted a multicenter, double-blind, randomized trial with a 2-by-2 factorial design to evaluate the effect of treatment with prednisolone or pentoxifylline. The primary end point was mortality at 28 days. Secondary end points included death or liver transplantation at 90 days and at 1 year. Patients with a clinical diagnosis of alcoholic hepatitis and severe disease were randomly assigned to one of four groups: a group that received a pentoxifylline-matched placebo and a prednisolone-matched placebo, a group that received prednisolone and a pentoxifylline-matched placebo, a group that received pentoxifylline and a prednisolone-matched placebo, or a group that received both prednisolone and pentoxifylline.ResultsA total of 1103 patients underwent randomization, and data from 1053 were available for the primary end-point analysis. Mortality at 28 days was 17% (45 of 269 patients) in the placebo-placebo group, 14% (38 of 266 patients) in the prednisolone-placebo group, 19% (50 of 258 patients) in the pentoxifylline-placebo group, and 13% (35 of 260 patients) in the prednisolone-pentoxifylline group. The odds ratio for 28-day mortality with pentoxifylline was 1.07 (95% confidence interval [CI], 0.77 to 1.49; P=0.69), and that with prednisolone was 0.72 (95% CI, 0.52 to 1.01; P=0.06). At 90 days and at 1 year, there were no significant between-group differences. Serious infections occurred in 13% of the patients treated with prednisolone versus 7% of those who did not receive prednisolone (P=0.002).ConclusionsPentoxifylline did not improve survival in patients with alcoholic hepatitis. Prednisolone was associated with a reduction in 28-day mortality that did not reach significance and with no improvement in outcomes at 90 days or 1 year. (Funded by the National Institute for Health Research Health Technology Assessment program; STOPAH EudraCT number, 2009-013897-42 , and Current Controlled Trials number, ISRCTN88782125 ).

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