Digestive Diseases and Sciences

, Volume 57, Issue 6, pp 1664–1671

Corticosteroid Plus Pentoxifylline Is Not Better than Corticosteroid Alone for Improving Survival in Severe Alcoholic Hepatitis (COPE Trial)

Authors

    • Department of GastroenterologyDayanand Medical College and Hospital
  • Omesh Goyal
    • Department of GastroenterologyDayanand Medical College and Hospital
  • Preeti Singla
    • Department of MedicineDayanand Medical College and Hospital
  • Dinesh Gupta
    • Department of MedicineDayanand Medical College and Hospital
  • Ajit Sood
    • Department of GastroenterologyDayanand Medical College and Hospital
  • Rajoo Singh Chhina
    • Department of GastroenterologyDayanand Medical College and Hospital
  • Ravinder Kumar Soni
    • Department of Community MedicineDayanand Medical College and Hospital
Original Article

DOI: 10.1007/s10620-012-2097-4

Cite this article as:
Sidhu, S.S., Goyal, O., Singla, P. et al. Dig Dis Sci (2012) 57: 1664. doi:10.1007/s10620-012-2097-4

Abstract

Background

Corticosteroids and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis (SAH), but not to the extent desired. Combining both drugs may lead to better survival, but has not yet been studied.

Aim

To compare the efficacy of corticosteroids plus pentoxifylline with that of corticosteroids alone in improving survival of SAH patients.

Methods

Of the 111 patients screened, 70 patients with SAH (Maddrey discriminant function (MDF) ≥ 32) were enrolled. Patients with active infection, bleeding, renal failure, or pancreatitis were excluded. Treatment was given for four weeks to group A (n = 36; prednisolone 40 mg/day plus pentoxifylline 400 mg thrice/day) and group B (n = 34; prednisolone 40 mg/day). Patients were followed up for 6 months. Data are expressed as median (range) or percentage.

Results

Baseline characteristics of the two groups were similar (MDF group A 78.5 (36.8–140.9), group B 74.9 (45.6–140.2)). Four-week and six-month survival in groups A and B were not significantly different (four-week 72.2 and 73.5%, respectively, p = 1.00; six-month 30.6 and 23.5%, respectively, p = 0.417). At seven days, 55.6% of patients in group A and 64.7% in group B had a Lille score <0.45 (p = 0.473). Six-month survival was significantly higher for patients with a Lille Score <0.45 than for those with a Lille score ≥0.45 (group A 55.5 vs. 0%, p = 0.0006; group B 36 vs. 0%, p = 0.0304). Biological improvement at 28 days was significant for both groups; however, the difference between the groups was not significant.

Conclusions

For patients with severe alcoholic hepatitis, a combination of corticosteroids and pentoxifylline has no additional survival advantage compared with corticosteroids alone.

Keywords

CorticosteroidsLille scorePentoxifyllineSevere alcoholic hepatitis

Copyright information

© Springer Science+Business Media, LLC 2012