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Therapy of hyponatremia in cirrhosis with a vasopressin receptor antagonist: a randomized double-blind multicenter trial.

Abstract：

BACKGROUND & AIMS:Dilutional hyponatremia is a frequent complication of cirrhosis partly because of nonosmotic vasopressin release. No effective therapy exists for this complication. Therefore, we investigated the effects of VPA-985, an orally active vasopressin V2 receptor antagonist, in patients with cirrhosis and dilutional hyponatremia. Primary endpoint was normalization of serum sodium (serum sodium >or=136 mmol/L). METHODS:Sixty patients with cirrhosis and dilutional hyponatremia were randomly assigned to 100 or 200 mg/day of VPA-985 or placebo in a double-blind study. Treatment was given with fluid restriction (1000 mL/day) until normalization of serum sodium or for 7 days. RESULTS:Normalization of serum sodium concentration was achieved in 27% and 50% of patients in the VPA-985 100 mg/day and 200 mg/day groups, respectively, but in none of the patients in the placebo group (P < 0.05 and P < 0.001, respectively). Treatment with VPA-985 was associated with a significant reduction in urine osmolality and body weight. Thirst sensation increased significantly in the VPA 200 mg group but not in the VPA 100 mg or placebo group. Serious adverse events were similar among the 3 groups. CONCLUSIONS:An orally active vasopressin receptor antagonist can correct hyponatremia in patients with cirrhosis and ascites. This represents a novel therapy of water retention in cirrhosis.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Gerbes AL,Gülberg V,Ginès P,Decaux G,Gross P,Gandjini H,Djian J,VPA Study Group.

doi

10.1053/gast.2003.50143

keywords:

subject

Has Abstract

pub_date

2003-04-01 00:00:00

pages

933-9

issue

4

eissn

0016-5085

issn

1528-0012

pii

S001650850300057X

journal_volume

124

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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