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| |  Satavaptan Reduces Ascites, Need for Paracentesis and Improves Renal Function in Patients With Advanced Cirrhosis: Presented at EASL By Cameron Johnston COPENHAGEN, Denmark -- April 30, 2009 -- Satavaptan reduces the need for paracentesis as well as the onset of spontaneous peritonitis and sepsis in patients with advanced cirrhosis of the liver, according to a study presented here on April 25 at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). "The use of a vasopressin V2 receptor antagonist to increase free-water clearance in cirrhotic patients with ascites has been shown to not only correct hyponatraemia -- it has also been shown to decrease the frequency of paracentesis in those patients who require frequent paracenteses," said lead author Florence Wong MD, Division of Clinical Investigation and Human Physiology, University of Toronto, Toronto, Ontario. The study, conducted in Canada, Spain, Croatia, Italy, and Belgium, included 234 patients who were randomised to receive satavaptan from 5 to 50 mg once daily (n = 186) or a placebo (n = 48) for 52 weeks. All patients had advanced liver disease, with 23.9% classified as Child-Pugh C. During the study, patients were allowed to continue with diuretic use, if indicated, and had paracentesis as needed. After 52 weeks of follow-up, patients receiving satavaptan underwent fewer paracenteses (7.4 procedures), even though they had also been using fewer diuretics compared with patients who received the placebo (9.3 procedures). This represents a 22% reduction in the rate of accumulation of ascites (P < .05). There were more cases of variceal bleeding in the satavaptan arm compared with the placebo arm (9.6% vs 6.3%), but fewer cases of spontaneous bacterial peritonitis or sepsis in the satavaptan group (11.8%) compared with the placebo group (23.9%). Because of the small cohort of patients involved in the study, these changes were not considered statistically significant. More cases of an adverse event related to renal impairment of any kind were seen in the satavaptan-treated patients (33.7%) versus placebo-treated patients (14.2%), and serum potassium levels increased beyond 5.5 mmol/L among patients in the treatment arm (40.6%) compared with those in the placebo arm (29.6%). Overall, although the reduction in the accumulation of ascites was not statistically significant, it was clinically important and justifies further study in this area. Ultimately, improving renal function and reducing the accumulation of ascites may result in better outcomes for those patients with advanced cirrhosis who are candidates for liver transplant.
[Presentation title: Effects of Satavaptan, an Oral Vasopressin V2 Receptor Antagonist, on Management of Ascites and Morbidity in Liver Cirrhosis in a Long-Term, Placebo-Controlled Study.]
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