"Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH) Trial". The New England Journal of Medicine. 2015.
Links to original sources: Wiki Journal Post Full Journal Article
Does pentoxifylline or prednisolone improve survival rates in patients with severe alcoholic hepatitis?
Pentoxifylline did not improve survival rates 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.
The STOPAH trial was a multicenter, randomized, double-blind, placebo-controlled trial with a 2-by-2 factorial design to evaluate the treatment effects of prednisolone and pentoxifylline on severe alcoholic hepatitis, a condition with high short-term mortality rates. The study found that pentoxifylline did not demonstrate improvements in patient survival. Prednisolone, while associated with a non-significant reduction in 28-day mortality, showed no significant improvement in mortality at 90 days or 1 year. Prednisolone treatment was linked to an increased risk of serious infections.
Current guidelines do not reflect the outcome of the STOPAH trial.
Multicenter, double-blind, randomized controlled trial with a 2-by-2 factorial design evaluating pentoxifylline and prednisolone as treatments.
- 1,103 patients were enrolled initially, with 1,053 available for the final analysis. - Inclusion criteria: - Age ≥18 years - Clinical diagnosis of alcoholic hepatitis - Severe disease (discriminant function ≥32 or bilirubin >80 μmol/L) - History of heavy and prolonged alcohol use - Exclusion criteria: - Jaundice for more than 3 months - Cessation of alcohol consumption for more than 2 months prior to randomization - Other causes of liver disease present
Patients were randomized into four groups: - Placebo for both pentoxifylline and prednisolone - Prednisolone alone - Pentoxifylline alone - Both prednisolone and pentoxifylline
Primary Outcome: - Mortality at 28 days: - Placebo–placebo: 17% - Prednisolone–placebo: 14% - Pentoxifylline–placebo: 19% - Prednisolone–pentoxifylline: 13%
- Death or liver transplantation at 90 days and at 1 year, with no significant differences observed between groups. - Serious infections occurred in 13% of prednisolone patients versus 7% who did not receive prednisolone (P=0.002).
The accuracy of diagnosing alcoholic hepatitis without liver biopsy could be questioned, potentially impacting the power of the study to detect a treatment effect. The study was stopped early due to funding limitations, limiting the follow-up data available for some participants.
Funded by the National Institute for Health Research Health Technology Assessment program.
Original publication in The New England Journal of Medicine, "Steroids or Pentoxifylline for Alcoholic Hepatitis", 2015.