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

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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.

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Acknowledgments

We sincerely thank Richard A. Parker and Rebecca Harvey, Medical Statisticians, Centre for Applied Medical Statistics, University of Cambridge, Department of Public Health and Primary Care, Institute of Public Health, Forvie Site, Robinson Way, Cambridge CB2 0SR UK (E-mail: rap50@medschl.cam.ac.uk, Tel: 01223 746605) for their contribution to the statistical analysis. Financial support—Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab.

Conflict of interest

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Authors and Affiliations

  1. Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141001, Punjab, India

    Sandeep Singh Sidhu, Omesh Goyal, Ajit Sood & Rajoo Singh Chhina

  2. Department of Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

    Preeti Singla & Dinesh Gupta

  3. Department of Community Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

    Ravinder Kumar Soni

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  1. Sandeep Singh Sidhu
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  2. Omesh Goyal
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Correspondence to Sandeep Singh Sidhu.

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Sidhu, S.S., Goyal, O., Singla, P. et al. Corticosteroid Plus Pentoxifylline Is Not Better than Corticosteroid Alone for Improving Survival in Severe Alcoholic Hepatitis (COPE Trial). Dig Dis Sci 57, 1664–1671 (2012). https://doi.org/10.1007/s10620-012-2097-4

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  • DOI: https://doi.org/10.1007/s10620-012-2097-4

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