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.

AIM:

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: P Ginès, F Wong, H Watson, R Terg, R Bruha, J-P Zarski, F Dudley, NormoCAT Study Investigators
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 31 Issue 8 Pg. 834-45 (Apr 2010) ISSN: 1365-2036 [Electronic] England
• PMID: 20102356 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antidiuretic Hormone Receptor Antagonists
• Diuretics
• Drug Combinations
• Morpholines
• Spiro Compounds
• Spironolactone
• Furosemide
• satavaptan

Topics

• Aged
• Antidiuretic Hormone Receptor Antagonists
• Ascites (drug therapy)
• Body Weight (drug effects)
• Diuretics (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Combinations
• Female
• Furosemide (administration & dosage, adverse effects)
• Humans
• Liver Cirrhosis (complications)
• Male
• Middle Aged
• Morpholines (administration & dosage, adverse effects)
• Prospective Studies
• Spiro Compounds (administration & dosage, adverse effects)
• Spironolactone (administration & dosage, adverse effects)
• Treatment Outcome