Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia

• Main Authors: Shuzhen Wang, Xin Zhang, Tao Han, Wen Xie, Yonggang Li, Hong Ma, Roman Liebe, Honglei Weng, Hui-Guo Ding
• Format: Article
• Language: English
• Published: BMC 2018-09-01
• Series: BMC Gastroenterology
• Subjects: Ascites; Hyponatremia; Liver cirrhosis; Survival; Tolvaptan
• Online Access: http://link.springer.com/article/10.1186/s12876-018-0857-0

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.