OBJECTIVE: To assess the effect of pentoxiphylline (a potent inhibitor of tumor necrosis factor alpha) on survival, on systemic and portal hemodynamics, and on cardiac function in patients with alcoholic cirrhosis. DESIGN: A randomized double-blind placebo-controlled trial. SETTING: A single center using parallel groups of patients to compare pentoxiphylline with placebo. PATIENTS: We recruited 24 patients with alcoholic cirrhosis (8 Child-Pugh B and 16 Child-Pugh C). INTERVENTIONS: Patients were randomly assigned to receive pentoxiphylline (400 mg tid; n = 12) or placebo (n = 12) over a 4-week period. OUTCOME MEASURES: The primary outcome was to extend short-term and long-term survival. Secondary outcomes included hemodynamic benefits (improvement in cardiac function and/or systemic vascular resistance index, or decrease in portal pressure). RESULTS:Portal pressure and cardiac function remained unchanged and there were no significant differences in short-term or long-term survival between treatment and placebo groups. The group on pentoxiphylline increased systemic vascular resistance and decreased cardiac indices (from 1,721 +/- 567 to 2,082 +/- 622 dyn.sec(-1) cm(-5) m(-2) and from 4.17 +/- 1.4 to 3.4 +/- 0.9 l.m(-2), p = 0.05). CONCLUSIONS: Although pentoxiphylline seems to provide some short-term hemodynamic benefits in patients with advanced alcoholic cirrhosis, this drug has no effect on survival or portal pressure in these patients.
RCT Entities:
OBJECTIVE: To assess the effect of pentoxiphylline (a potent inhibitor of tumor necrosis factor alpha) on survival, on systemic and portal hemodynamics, and on cardiac function in patients with alcoholic cirrhosis. DESIGN: A randomized double-blind placebo-controlled trial. SETTING: A single center using parallel groups of patients to compare pentoxiphylline with placebo. PATIENTS: We recruited 24 patients with alcoholic cirrhosis (8 Child-Pugh B and 16 Child-Pugh C). INTERVENTIONS:Patients were randomly assigned to receive pentoxiphylline (400 mg tid; n = 12) or placebo (n = 12) over a 4-week period. OUTCOME MEASURES: The primary outcome was to extend short-term and long-term survival. Secondary outcomes included hemodynamic benefits (improvement in cardiac function and/or systemic vascular resistance index, or decrease in portal pressure). RESULTS: Portal pressure and cardiac function remained unchanged and there were no significant differences in short-term or long-term survival between treatment and placebo groups. The group on pentoxiphylline increased systemic vascular resistance and decreased cardiac indices (from 1,721 +/- 567 to 2,082 +/- 622 dyn.sec(-1) cm(-5) m(-2) and from 4.17 +/- 1.4 to 3.4 +/- 0.9 l.m(-2), p = 0.05). CONCLUSIONS: Although pentoxiphylline seems to provide some short-term hemodynamic benefits in patients with advanced alcoholic cirrhosis, this drug has no effect on survival or portal pressure in these patients.
Authors: Elena Buzzetti; Maria Kalafateli; Douglas Thorburn; Brian R Davidson; Maja Thiele; Lise Lotte Gluud; Cinzia Del Giovane; Gro Askgaard; Aleksander Krag; Emmanuel Tsochatzis; Kurinchi Selvan Gurusamy Journal: Cochrane Database Syst Rev Date: 2017-03-31