Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis

Background Tolvaptan has been approved in Japan for the treatment of hepatic edema. An important consideration in providing a clinical benefit to patients with liver cirrhosis is the improvement of ascites-related clinical symptoms. In the present post hoc analysis, we aimed to identify factors that...

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Bibliographic Details
Published in:Journal of gastroenterology 2017-02, Vol.52 (2), p.229-236
Main Authors: Sakaida, Isao, Terai, Shuji, Nakajima, Koji, Shibasaki, Yoshiyuki, Tachikawa, Sayaka, Tsubouchi, Hidetsugu
Format: Article
Language:English
Subjects:
Abdominal Surgery
Aged
Analysis
Antidiuretic Hormone Receptor Antagonists - pharmacology
Antidiuretic Hormone Receptor Antagonists - therapeutic use
Ascites - drug therapy
Ascites - pathology
Benzazepines - pharmacology
Benzazepines - therapeutic use
Biliary Tract
Blood Urea Nitrogen
Body Weight
Care and treatment
Colorectal Surgery
Female
Gastroenterology
Hepatology
Humans
Japan
Liver cirrhosis
Liver Cirrhosis - drug therapy
Liver Cirrhosis - pathology
Male
Medical colleges
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Middle Aged
Original Article—Liver
Original —Liver, Pancreas, and Biliary Tract
Pancreas
Predictive Value of Tests
Surgical Oncology
Urine
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Summary:Background Tolvaptan has been approved in Japan for the treatment of hepatic edema. An important consideration in providing a clinical benefit to patients with liver cirrhosis is the improvement of ascites-related clinical symptoms. In the present post hoc analysis, we aimed to identify factors that were predictive of the potency of tolvaptan, and to examine the relationship between changes in initial urine volume and improvement in ascites-related clinical symptoms. Methods This post hoc analysis was based on three previous phase 2 and 3 clinical trials of tolvaptan in patients with liver cirrhosis. Predictive factors associated with a change in initial urine volume were identified. A change of ≥500 mL from baseline confirmed the pharmacological action of tolvaptan treatment. The relationship between the change in initial urine volume and improvement in ascites-related clinical symptoms was also examined. Results A total of 152 patients were enrolled in this study. Body weight and BUN were identified as predictive parameters. Among patients with a change in initial urine volume of ≥500 mL, 75 % demonstrated improvement in ascites-related clinical symptoms, while no improvement was seen in those with a change of
ISSN:0944-1174
1435-5922
DOI:10.1007/s00535-016-1233-x