title: 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.
  
  
  OBJECTIVE
  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.affiliation: Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. sandeepsidhu1963@gmail.com
authors.forename: Sandeep Singh
authors.initials: SS
authors.lastname: Sidhu
authors.forename: Omesh
authors.initials: O
authors.lastname: Goyal
authors.forename: Preeti
authors.initials: P
authors.lastname: Singla
authors.forename: Dinesh
authors.initials: D
authors.lastname: Gupta
authors.forename: Ajit
authors.initials: A
authors.lastname: Sood
authors.forename: Rajoo Singh
authors.initials: RS
authors.lastname: Chhina
authors.forename: Ravinder Kumar
authors.initials: RK
authors.lastname: Soni
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D002423:Cause of Death; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006519:Hepatitis, Alcoholic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007194:India; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010431:Pentoxifylline / Q000008:administration & dosage*; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D010431:Pentoxifylline