Observational Study
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World J Gastroenterol. Aug 28, 2014; 20(32): 11400-11405
Published online Aug 28, 2014. doi: 10.3748/wjg.v20.i32.11400
Clinical efficacy of tolvaptan for treatment of refractory ascites in liver cirrhosis patients
Xin Zhang, Shu-Zhen Wang, Jun-Fu Zheng, Wen-Min Zhao, Peng Li, Chun-Lei Fan, Bing Li, Pei-Ling Dong, Lei Li, Hui-Guo Ding
Xin Zhang, Shu-Zhen Wang, Jun-Fu Zheng, Wen-Min Zhao, Peng Li, Chun-Lei Fan, Bing Li, Pei-Ling Dong, Lei Li, Hui-Guo Ding, Department of Gastroenterology and Hepatology, Beijing You’an Hospital, Affiliated with Capital Medical University, Beijing 100069, China
Author contributions: Zhang X and Wang SZ contributed equally to the manuscript; Ding HG, Zhang X, Wang SZ and Zheng JF analyzed the data; Zhang X, Wang SZ and Ding HG wrote the manuscript; Ding HG was also responsible for this project and the final revised manuscript; The other authors contributed to data acquisition, patient care and follow up.
Supported by The Program of Beijing Science and Technology Commission, No. D131100005313004; and the Beijing High-Level Talent Academic Leader/Personnel Training Programs awarded to Ding HG, 2011-2-19; Li B, 2013-3-072; and Li L, 2013-3-073
Correspondence to: Hui-Guo Ding, MD, PhD, Director, Department of Gastroenterology and Hepatology, Beijing You’an Hospital, Affiliated with Capital Medical University, Fengtai District, Beijing 100069, China. dinghuiguo@medmail.com.cn
Telephone: +86-10-83997155 Fax: +86-10-63295525
Received: February 8, 2014
Revised: April 11, 2014
Accepted: May 12, 2014
Published online: August 28, 2014
Processing time: 201 Days and 19.7 Hours
Abstract

AIM: To evaluate the efficacy and safety of tolvaptan to treat refractory ascites in decompensated liver cirrhosis patients with or without further complications, such as hepatorenal syndrome and/or hepatocellular carcinoma.

METHODS: Thirty-nine patients (mean age 55 years, males: 32) with decompensated liver cirrhosis and refractory ascites were enrolled. All patients received a combination of tolvaptan (15 mg/d for 5-14 d) and diuretics (40-80 mg/d of furosemide and 80-160 mg/d of spironolactone). The etiology of cirrhosis included hepatitis B (69.2%), hepatitis C (7.7%) and alcohol-induced (23.1%). Changes in the urine excretion volume, abdominal circumference and edema were assessed. The serum sodium levels were also measured, and adverse events were recorded. A follow-up assessment was conducted 1 mo after treatment with tolvaptan.

RESULTS: Tolvaptan increased the mean urine excretion volume (1969.2 ± 355.55 mL vs 3410.3 ± 974.1 mL, P < 0.001), and 89.7% of patients showed improvements in their ascites, 46.2% of whom showed significant improvements. The overall efficacy of tolvaptan in all patients was 89.7%; the efficacies in patients with hepatocellular carcinoma and hepatorenal syndrome were 84.2% and 77.8%, respectively. The incidence of hyponatremia was 53.8%. In patients with hyponatremia, the serum sodium levels increased after tolvaptan treatment (from 128.1 ± 4.22 mEq/L vs 133.1 ± 3.8 mEq/L, P < 0.001). Only mild drug-related adverse events, including thirst and dry mouth, were observed.

CONCLUSION: Tolvaptan is a promising aquaretic for the treatment of refractory ascites in patients with decompensated liver cirrhosis.

Keywords: Tolvaptan; Refractory ascites; Hyponatremia; Decompensation; Liver cirrhosis

Core tip: This study showed that tolvaptan, a new aquaretic drug, is an effective and safe potential treatment for refractory ascites in patients with decompensated liver cirrhosis, especially in patients with further complications, such as hepatorenal syndrome and/or hepatocellular carcinoma. Tolvaptan significantly increased the serum sodium levels in patients with hyponatremia.