Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis☆
Received 17 January 2010; received in revised form 22 February 2010; accepted 23 February 2010. published online 31 May 2010.
Refers to article:
May vaptans contribute to the treatment of refractory ascites?
, 07 May 2010
Francesco Salerno, Massimo Cazzaniga, Silvia Accordino
Journal of Hepatology
August 2010 (Vol. 53, Issue 2, Pages 225-227) Full Text |
Full-Text PDF (210 KB)
Background & Aims
Cirrhotic patients with recurrent ascites frequently require paracentesis despite diuretic therapy. Vasopressin receptor antagonists, by increasing free water clearance, may reduce the recurrence of ascites. To investigate the effects of the addition of a vasopressin V2 receptor antagonist, satavaptan, to 100mg spironolactone on ascites recurrence after a large volume paracentesis in patients with liver cirrhosis irrespective of the presence of hyponatraemia.
Methods
One hundred and fifty one cirrhotic patients with recurrent ascites with or without hyponatraemia, and normal to mildly abnormal renal function were randomised in a double-blind study to receive either 5mg (n=39), 12.5mg (n=36), 25mg (n=40) of satavaptan or placebo (n=36) for 12weeks. Their Child–Pugh scores were 9.2±1.3, 8.7±1.7, 8.8±1.3, and 9.0±1.5, respectively.
Results
Median time to first paracentesis was 23, 26, and 17days with satavaptan 5, 12.5, and 25mg, respectively, versus 14days with placebo (ns for all doses). The frequency of paracenteses was decreased significantly (p<0.05) in all satavaptan groups versus placebo. Mean increase in ascites was 2.82±0.48L/week for placebo versus 2.12±0.40, 2.14±0.33, and 2.06±0.40L/week for the 5, 12.5, and 25mg of satavaptan, respectively (ns for all doses). Similar numbers of patients experienced major adverse events in all groups. Increases in serum creatinine, orthostatic changes in systolic pressure and thirst were more common with satavaptan.
Conclusions
Satavaptan has the potential to reduce recurrence of ascites after a large volume paracentesis at doses from 5 to 25mg in cirrhotic patients with ascites.
1Department of Medicine, University of Toronto, Canada
2Hospital Clinic, University of Barcelona, Institut d’Investigacions Biomèdiques August Pi-Sunyer (IDIBAPS), CIBER de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Catalunya, Spain
3Internal Medicine, Clinical Development, Sanofi-Aventis R&D, Chilly-Mazarin, France
ABSTRACT