title: Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis.
abstract: OBJECTIVE
  Pentoxifylline, an inhibitor of tumor necrosis factor-alpha, is given to patients with liver diseases, but its effects in patients with advanced cirrhosis are unknown. We performed a randomized, placebo-controlled, double-blind trial of its effects in patients with cirrhosis.
  
  
  METHODS
  A total of 335 patients with cirrhosis (Child-Pugh class C) were assigned to groups given either pentoxifylline (400 mg, orally, 3 times daily; n = 164) or placebo (n = 171) for 6 months. The primary end point was mortality at 2 months. Secondary end points were mortality at 6 months and development of liver-related complications.
  
  
  RESULTS
  By 2 months, 28 patients in the pentoxifylline group (16.5%) and 31 in the placebo group (18.2%) had died (P = .84). At 6 months, 50 patients in the pentoxifylline group (30.0%) and 54 in the placebo group (31.5%) had died (P = .75). The proportions of patients without complications (eg, bacterial infection, renal insufficiency, hepatic encephalopathy, or gastrointestinal hemorrhage) were higher in the pentoxifylline group than in the placebo group at 2 months (78.6% vs 63.4%; P = .006) and 6 months (66.8% vs 49.7%; P = .002). The probability of survival without complications was higher in the pentoxifylline group than in the placebo group at 2 and 6 months (P = .04). In multivariate analysis, the factors associated with death were age, the Model for End-Stage Liver Disease score, and presence of early-stage carcinoma. Treatment with pentoxifylline was the only factor associated with liver-related complications.
  
  
  CONCLUSIONS
  Although pentoxifylline does not decrease short-term mortality in patients with advanced cirrhosis, it does reduce the risk of complications.
authors.affiliation: INSERM, Unité 773, Centre de Recherche Biomédicle Bichat-Beaujon CRB3, Paris, France and Service d'Hépatologie, Hôpital Beaujon, Clichy, France. didier.lebrec@inserm.fr
authors.forename: Didier
authors.initials: D
authors.lastname: Lebrec
authors.forename: Dominique
authors.initials: D
authors.lastname: Thabut
authors.forename: Frederic
authors.initials: F
authors.lastname: Oberti
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Perarnau
authors.forename: Bertrand
authors.initials: B
authors.lastname: Condat
authors.forename: Helene
authors.initials: H
authors.lastname: Barraud
authors.forename: Faouzi
authors.initials: F
authors.lastname: Saliba
authors.forename: Nicolas
authors.initials: N
authors.lastname: Carbonell
authors.forename: Philippe
authors.initials: P
authors.lastname: Renard
authors.forename: Marie-Jose
authors.initials: MJ
authors.lastname: Ramond
authors.forename: Richard
authors.initials: R
authors.lastname: Moreau
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D005602:France / Q000453:epidemiology; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000517:prevention & control; D006501:Hepatic Encephalopathy / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D008875:Middle Aged; D010431:Pentoxifylline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D051437:Renal Insufficiency / Q000209:etiology / Q000517:prevention & control; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D014409:Tumor Necrosis Factor-alpha; D010431:Pentoxifylline