STASH
Trial question
What is the role of a tapered prednisolone regimen in patients with severe alcohol-associated hepatitis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
2.0% female
98.0% male
N = 254
254 patients (5 female, 249 male).
Inclusion criteria: patients with severe alcohol-associated hepatitis.
Interventions
N=127 tapered-dose prednisolone (40 mg/day, tapered by 10 mg each week over 4 weeks).
N=127 fixed-dose prednisolone (40 mg/day for 4 weeks).
Primary outcome
Rate of infection on day 90
19.7%
33.1%
33.1 %
24.8 %
16.6 %
8.3 %
0.0 %
Tapered-dose
prednisolone
Fixed-dose
prednisolone
Significant
decrease ▼
NNT = 7
Significant decrease in the rate of infection on day 90 (19.7% vs. 33.1%; HR 0.57, 95% CI 0.35 to 0.94).
Secondary outcomes
Significant decrease in microbiologically proven infection (8.6% vs. 19%; RR 0.45, 95% CI 0.07 to 0.83).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with severe alcohol-associated hepatitis, tapered-dose prednisolone was superior to fixed-dose prednisolone with respect to the rate of infection on day 90.
Reference
Anand V Kulkarni, Karan Kumar, Suprabhat Giri et al. Infections in Standard or Tapered Dose of Prednisolone for Alcohol-Associated Hepatitis: A Randomized Trial (STASH Trial). Am J Gastroenterol. 2025 Mar 13. Online ahead of print.
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