BMC Gastroenterology (Sep 2018)

Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia

  • Shuzhen Wang,
  • Xin Zhang,
  • Tao Han,
  • Wen Xie,
  • Yonggang Li,
  • Hong Ma,
  • Roman Liebe,
  • Honglei Weng,
  • Hui-Guo Ding

DOI
https://doi.org/10.1186/s12876-018-0857-0
Journal volume & issue
Vol. 18, no. 1
pp. 1 – 8

Abstract

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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.

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