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Published on: May 13, 2016
Prednisolone or pentoxifylline for alcoholic hepatitis
Mark R Thursz1, Paul Richardson, Michael Allison
1From 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.
Pentoxifylline did not improve survival for alcoholic hepatitis. Prednisolone showed a trend toward reducing 28-day mortality but did not significantly impact long-term outcomes or increase serious infections.
Area of Science:
- Hepatology
- Clinical Medicine
- Gastroenterology
Background:
- Alcoholic hepatitis is a severe liver condition with high short-term mortality.
- Current treatments like prednisolone and pentoxifylline have uncertain efficacy.
Purpose of the Study:
- To evaluate the effectiveness of prednisolone and pentoxifylline in treating severe alcoholic hepatitis.
- To assess their impact on short-term and long-term mortality.
Main Methods:
- A multicenter, double-blind, randomized trial with a 2x2 factorial design.
- Patients received prednisolone, pentoxifylline, both, or placebo.
- Primary endpoint was 28-day mortality; secondary endpoints included 90-day and 1-year mortality and liver transplantation.
Main Results:
- No significant difference in 28-day mortality between pentoxifylline and placebo groups (OR 1.07, P=0.69).
- Prednisolone showed a non-significant trend toward reduced 28-day mortality (OR 0.72, P=0.06).
- Serious infections were more frequent in patients receiving prednisolone (13% vs 7%, P=0.002).
Conclusions:
- Pentoxifylline is not effective in improving survival for alcoholic hepatitis.
- Prednisolone did not significantly improve survival at 28 days, 90 days, or 1 year and was associated with increased infection risk.
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