title: Satavaptan treatment for ascites in patients with cirrhosis: a meta-analysis of effect on hepatic encephalopathy development.
abstract: Satavaptan, a vasopressin V2-receptor antagonist, has been shown to improve hyponatraemia in patients with cirrhosis. Hyponatraemia has been associated with an increased risk of hepatic encephalopathy. The objective is to evaluate the efficacy of satavaptan in reducing the risk of new episodes of hepatic encephalopathy. 1,200 patients with cirrhosis and uncomplicated ascites were included in three randomised double-blind studies comparing satavaptan (5-10 mg/day) vs placebo over a one-year treatment period. Effects on incidence of hepatic encephalopathy episodes in individual study and pooled databases were determined with analyses adjusted for hyponatraemia and previous episodes of encephalopathy. Hyponatraemia was improved by satavaptan. Three hundred and ninety-five hepatic encephalopathy episodes were recorded. The risk of an episode and the mean number of episodes were not reduced by satavaptan in any of the three studies in the overall population or in patients who were hyponatraemic on entry. These findings were confirmed in analysis of the pooled data. Satavaptan did not reduce the frequency of hepatic encephalopathy in patients with cirrhosis and ascites.
authors: Sanofi R&D, 1 avenue Pierre Brossolette, 91385 Chilly-Mazarin, France. hugh.watson@sanofi.com
authors: Hugh
authors: H
authors: Watson
authors: Peter
authors: P
authors: Jepsen
authors: Florence
authors: F
authors: Wong
authors: Pere
authors: P
authors: Ginès
authors: Juan
authors: J
authors: Córdoba
authors: Hendrik
authors: H
authors: Vilstrup
mesh_terms: D065092:Antidiuretic Hormone Receptor Antagonists; D001201:Ascites / Q000188:drug therapy*; D006501:Hepatic Encephalopathy / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy*; D009025:Morpholines / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013141:Spiro Compounds / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D009025:Morpholines; D013141:Spiro Compounds; C103281:satavaptan