title: Clinical trial: short-term effects of combination of satavaptan, a selective vasopressin V2 receptor antagonist, and diuretics on ascites in patients with cirrhosis without hyponatraemia--a randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  There is little information on the effects of vaptans in patients with cirrhosis.
  
  
  OBJECTIVE
  To investigate the short-term effects of satavaptan, a selective vasopressin V2 receptor antagonist on ascites in cirrhosis without hyponatraemia.
  
  
  METHODS
  A total of 148 patients with cirrhosis, ascites and serum sodium >130 mmol/L were included in a multicentre, double-blind, randomized, controlled study of 14 days comparing three fixed doses of satavaptan (5 mg, 12.5 mg or 25 mg once daily) vs. placebo. Average MELD scores were: 13.4, 12.3, 13.8 and 13.1 respectively. All patients received spironolactone 100 mg/day plus furosemide 20-25 mg/day.
  
  
  RESULTS
  Satavaptan treatment was associated with a decrease in ascites (mean change in body weight was -0.36 kg (+/-3.03) for placebo vs. -2.46 kg (+/-3.11), -2.08 kg (+/-4.17) and -2.28 kg (+/-3.24) for the 5 mg, 12.5 mg and 25 mg doses respectively; P = 0.036, P = 0.041 and P = 0.036 for satavaptan 5, 12.5 and 25 mg/day vs. placebo respectively). Thirst and slight increases in serum sodium were more common in patients treated with satavaptan compared with placebo, while other adverse events were similar.
  
  
  CONCLUSIONS
  The administration satavaptan for a 14-day period is associated with reduction in ascites in patients with moderately severe cirrhosis without hyponatraemia under diuretic treatment.
authors.affiliation: Liver Unit, Hospital Clínic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi-Sunyer (IDIBAPS), CIBER de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Catalunya, Spain. pgines@clinic.ub.es
authors.forename: P
authors.initials: P
authors.lastname: Ginès
authors.forename: F
authors.initials: F
authors.lastname: Wong
authors.forename: H
authors.initials: H
authors.lastname: Watson
authors.forename: R
authors.initials: R
authors.lastname: Terg
authors.forename: R
authors.initials: R
authors.lastname: Bruha
authors.forename: J-P
authors.initials: JP
authors.lastname: Zarski
authors.forename: F
authors.initials: F
authors.lastname: Dudley
mesh_terms: D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists; D001201:Ascites / Q000188:drug therapy*; D001835:Body Weight / Q000187:drug effects; D004232:Diuretics / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005665:Furosemide / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D013141:Spiro Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D013148:Spironolactone / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D004232:Diuretics; D004338:Drug Combinations; D009025:Morpholines; D013141:Spiro Compounds; D013148:Spironolactone; D005665:Furosemide; C103281:satavaptan