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

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.

Keywords: Ascites; Hyponatremia; Liver cirrhosis; Survival; Tolvaptan.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by the Ethics Committees of Beijing Youan Hospital affiliated to Capital Medical University. Signed informed consent was obtained from each patient for using samples,materials and publication.

Consent for publication

Not applicable.

Competing interests

The authors have no competing interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The flow chart of patients eligibility of the clinical trial
Fig. 2
Fig. 2
Six-month survival of cirrhotic patients with ascites who received tolvaptan or placebo treatment. The Kaplan–Meier survival curves was not statistically significant difference in patients without hyponatremia between tolvaptan and placebo treatment (P > 0.05, a), also in cirrhotic patients with hyponatremia(P > 0.05, b).However, the survival of patients with resolved serum sodium was significantly higher than of those unresolved serum sodium either tolvaptan or placebo treatment(P < 0.01, c)

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