Original Article

Digestive Diseases and Sciences

, Volume 57, Issue 6, pp 1664-1671

First online:

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

  • Sandeep Singh SidhuAffiliated withDepartment of Gastroenterology, Dayanand Medical College and Hospital Email author 
  • , Omesh GoyalAffiliated withDepartment of Gastroenterology, Dayanand Medical College and Hospital
  • , Preeti SinglaAffiliated withDepartment of Medicine, Dayanand Medical College and Hospital
  • , Dinesh GuptaAffiliated withDepartment of Medicine, Dayanand Medical College and Hospital
  • , Ajit SoodAffiliated withDepartment of Gastroenterology, Dayanand Medical College and Hospital
  • , Rajoo Singh ChhinaAffiliated withDepartment of Gastroenterology, Dayanand Medical College and Hospital
  • , Ravinder Kumar SoniAffiliated withDepartment of Community Medicine, Dayanand Medical College and Hospital

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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.

Keywords

Corticosteroids Lille score Pentoxifylline Severe alcoholic hepatitis