Corticosteroid plus pentoxifylline is not better than corticosteroid alone for improving survival in severe alcoholic hepatitis (COPE trial).

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.

• Authors: Sandeep Singh Sidhu, Omesh Goyal, Preeti Singla, Dinesh Gupta, Ajit Sood, Rajoo Singh Chhina, Ravinder Kumar Soni
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 57 Issue 6 Pg. 1664-71 (Jun 2012) ISSN: 1573-2568 [Electronic] United States
• PMID: 22388710 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Pentoxifylline

Topics

• Adrenal Cortex Hormones (administration & dosage)
• Adult
• Aged
• Analysis of Variance
• Cause of Death
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Therapy, Combination
• Hepatitis, Alcoholic (diagnosis, drug therapy, mortality)
• Hospitalization (statistics & numerical data)
• Humans
• India
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Multivariate Analysis
• Pentoxifylline (administration & dosage)
• Prognosis
• Proportional Hazards Models
• Prospective Studies
• Reference Values
• Risk Assessment
• Severity of Illness Index
• Survival Rate
• Treatment Outcome