BACKGROUND & AIMS:: 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 endpoint was mortality at 2 months. The secondary endpoints were mortality at 6 months and the 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=0.84). At 6 months, 50 patients in the pentoxifylline group (30.0%) and 54 in the placebo group (31.5%) had died (P=0.75). The proportions of patients without complications (bacterLebrec Dial 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=0.006) and 6 months (66.8% vs. 49.7%, P=0.002). The probability of survival without complications was higher in the pentoxifylline group than in the placebo group at 2 and 6 months (P=0.04). In multivariate analysis, the factors associated with death were age, the Model for End-Stage Liver Disease score and the 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.