STOPAH: Steroids or pentoxifyline for alcoholic hepatitis

Conditions

Alcoholic hepatitis Digestive System Alcoholic liver disease

Atkinson SR, Way MJ, McQuillin A, Morgan MY, Thursz MR.

2017-02-0249 citations

10.1016/j.jhep.2017.01.018

In Patients With Severe Alcoholic Hepatitis, Prednisolone Increases Susceptibility to Infection and Infection-Related Mortality, and Is Associated With High Circulating Levels of Bacterial DNA.

Vergis N, Atkinson SR, Knapp S, Maurice J, Allison M, Austin A, Forrest EH, Masson S, McCune A, Patch D, Richardson P, Gleeson D, Ryder SD, Wright M, Thursz MR.

2016-12-30150 citations

10.1053/j.gastro.2016.12.019

The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2 × 2 factorial randomised controlled trial.

Thursz M, Forrest E, Roderick P, Day C, Austin A, O'Grady J, Ryder S, Allison M, Gleeson D, McCune A, Patch D, Wright M, Masson S, Richardson P, Vale L, Mellor J, Stanton L, Bowers M, Ratcliffe I, Downs N, Kirkman S, Homer T, Ternent L.

2015-12-0126 citations

10.3310/hta191020

Prednisolone or Pentoxifylline for Alcoholic Hepatitis

Mark R. Thursz, Paul Richardson, Michael Allison, Andrew Austin, Megan Bowers et al. (23 authors)

New England Journal of Medicine2015-04-22744 citations

10.1056/nejmoa1412278

Prednisolone but Not PTX Improves 28-Day Mortality in Patients with Alcoholic Hepatitis

M. Vinall, Mark Thursz

MD Conference Express2014-12-01

10.1177/155989771448004

Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial.

Forrest E, Mellor J, Stanton L, Bowers M, Ryder P, Austin A, Day C, Gleeson D, O'Grady J, Masson S, McCune A, Patch D, Richardson P, Roderick P, Ryder S, Wright M, Thursz M.

2013-08-1955 citations

10.1186/1745-6215-14-262

Interventions

The planned interventions will be prednisolone (40 mg for 4 weeks) or pentoxifylline (400 mg 3 times a day for 4 weeks): 1. Group A: placebo/placebo 2. Group B: placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical alcoholic hepatitis: 1.1. Serum bilirubin greater than 80 µmol/L 1.2. History of excess alcohol (greater than 80 g/day male, greater than 60 g/day female) 2. Less than 4 weeks from admission to hospital 3. Discriminant Function (DF) greater than or equal to 32 4. Informed consent 5. Minimum 18 years old, no upper limit, either sex

Exclusion criteria

Exclusion criteria: 1. Abstinence of more than 6 weeks prior to randomisation 2. Duration of jaundice greater than 3 months 3. Other causes of liver disease 4. Evidence of current malignancy (except non-melanotic skin cancer) 5. Previous entry into the study, or use of either prednisolone or PTX within 6 months 6. Aspartate aminotransferase (AST) greater than 500 or alanine aminotransferase (ALT) greater than 300 7. Patients with a serum creatinine greater than 500 µmol/L or requiring renal support 8. Patients dependent upon inotropic support 9. Active gastro-intestinal haemorrhage and untreated sepsis

Design outcomes

Primary

Measure	Time frame
Mortality at 28 days	—

Secondary

Measure	Time frame
1. Mortality at 3 and 12 months 2. Outcome relative to Glasgow Alcoholic Hepatitis Score 3. Assessment of biochemical response to treatment 4. Duration of hospitalisation 5. The development of new or recurrent renal failure 6. Development of gastro-intestinal haemorrhage and sepsis 7. Incremental NHS costs and quality of life at 3 and 12 months	—

Countries

United Kingdom

Outcome results

None listed