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Randomized Controlled Trial Multicenter Study
Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis.
- Didier Lebrec, Dominique Thabut, Frederic Oberti, Jean-Marc Perarnau, Bertrand Condat, Helene Barraud, Faouzi Saliba, Nicolas Carbonell, Philippe Renard, Marie-Jose Ramond, Richard Moreau, Thierry Poynard, and Pentocir Group.
- INSERM, Unité 773, Centre de Recherche Biomédicle Bichat-Beaujon CRB3, Paris, France and Service d'Hépatologie, Hôpital Beaujon, Clichy, France. didier.lebrec@inserm.fr
- Gastroenterology. 2010 May 1;138(5):1755-62.
Background & AimsPentoxifylline, 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.MethodsA 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.ResultsBy 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.ConclusionsAlthough pentoxifylline does not decrease short-term mortality in patients with advanced cirrhosis, it does reduce the risk of complications.Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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