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BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0.

Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia.

Author information

1
Department of Gastroenterology and Hepatology, Beijing You'an Hospital, Affiliated with Capital Medical University, Fengtai District, Beijing, 100069, China.
2
Department of Gastroenterology, Tianjin Third Central Hospital, Tianjin, China.
3
Department of Hepatology, Beijing Ditan Hospital, Affiliated with Capital Medical University, Beijing, China.
4
Department of Hepatology, PLA 302 Hospital, Beijing, China.
5
Liver Diseases Center, Beijing Friendship Hospital, Affiliated with Capital Medical University, Beijing, China.
6
Department of Medicine II, Section Molecular Hepatology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
7
Department of Gastroenterology and Hepatology, Beijing You'an Hospital, Affiliated with Capital Medical University, Fengtai District, Beijing, 100069, China. dinghuiguo@medmail.com.cn.

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

PMID:
30180806
PMCID:
PMC6123923
DOI:
10.1186/s12876-018-0857-0
[Indexed for MEDLINE]
Free PMC Article

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