By Cheryl Lathrop
BOSTON -- November 3, 2009 -- Adding satavaptan to diuretics in the treatment of ascites in cirrhotic patients showed modest effects on recurrence, but those patients had poorer survival compared with those given diuretics alone, researchers stated here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Patients with cirrhosis and ascites are usually treated with diuretics and repeated large volume paracentesis (LVP).
Florence Wong, MD, Toronto General Hospital, Toronto, Ontario, and colleagues reported findings from the Satavaptan in the Prevention of Ascites Recurrence (SPARe-1) study here at a poster session on October 31.
Ascites affects 10% of all cirrhotic patients. LVP therapy requires a lot of medical "manpower," and is inconvenient for patients. The V2 receptor antagonist, satavaptan, reduced the recurrence of ascites in dose-finding studies when added to low-dose spironolactone in cirrhotic patients requiring repeated LVP. The efficacy of this treatment strategy needed to be confirmed in a larger cohort with different diuretic regimens.
The objective of the multicentre, double-blind, parallel-group SPARe-1 trial was to determine the effects of satavaptan on the frequency of LVP over 12 weeks. The study also sought to determine the safety of satavaptan over 12 months when used in combination with diuretics. The primary endpoint was the number of paracentesis treatments over 12 weeks.
The age of both groups was approximately 57 years, and roughly 75% of each group was male. Inclusion criteria included: recurrent ascites secondary to liver cirrhosis, an LVP (4 litres or more) no more than 24 hours before randomisation, and a history of at least 1 other LVP in the previous 3 months.
A total of 496 patients with cirrhosis of the liver and recurrent ascites who were treated with diuretics and repeated LVP were randomised (2:1) to either satavaptan 5 mg/day (n = 328) for the first 7 days, then 5 to 10 mg/day with individual dose adjustments, or placebo (n = 168). All patients continued their usual diuretics, which could be adjusted (separate from the satavaptan dose adjustments).
The use of satavaptan reduced the amount of ascites accumulated, and delayed the need for a repeat LVP. It did not, however, significantly decrease the number of LVPs over 12 weeks.
The frequency of different types of adverse events was similar for the 2 treatment groups (with the exception of variceal bleeding (placebo = 5%, satavaptan = 8%). The outcome of events, however, was more frequently fatal in patients that received satavaptan. An independent Drug Monitoring Board recommended stopping the study before the completion of the 12 months.
[Presentation title: Double-Blind, Placebo-Controlled Study of Satavaptan in the Management of Recurrent Ascites: The SPARe-1 Study. Abstract 304]
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