Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia

Abstract

Background

Although tolvaptan treatment improves hyponatremia, only few studies have investigated whether tolvaptan actually benefits the survival of cirrhotic patients. This study evaluated the impact of tolvaptan on six-month survival of decompensated cirrhotic patients with and without hyponatremia.

Methods

Two hundred forty-nine decompensated cirrhotic patients with or without hyponatremia were enrolled in a multicenter cohort study. Patients were divided into two groups according to receiving either tolvaptan or placebo treatment for 7-day. Subsequently, the patients were followed up for 6 months.

Results

Two hundred thirty patients, including 98 with hyponatremia (tolvaptan vs. placebo: 69 vs. 29) finished the study. Tolvaptan did not alter serum sodium levels and survival outcome of decompensated cirrhotic patients without hyponatremia. However, tolvaptan treatment remarkably improved serum sodium levels and six-month survival in patients with hyponatremia. Following tolvaptan treatment, serum sodium levels were restored to normal in 63.8% of patients, whereas in patients receiving placebo, only 36.2% showed the same effect (P < 0.05). Compared to a six-month survival rate of 68.97% in patients receiving placebo, the survival rate in tolvapatan-treated patients was 89.94% (P < 0.05). Furthermore, six-month survival rate in the tolvaptan-treated hyponatremia patients with resolved serum sodium was 81.32%, whereas the survival in those with unresolved serum sodium was only 24% (P < 0.05).

Conclusions

Tolvaptan improves short term survival in most decompensated cirrhotic hyponatremia patients with resolved serum sodium.

Trials registration

Clinical trial one: ClinicalTrials.gov ID:NCT00664014, Registered on April 14, 2008.

Clinical trial two: ClinicalTrials.gov ID:NCT01349335, Registered on March 5, 2010.

Clinical trial three: ClinicalTrials.gov ID:NCT01349348, Registered on May 4, 2011.