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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 tha...

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Autores principales: Sakaida, Isao, Terai, Shuji, Nakajima, Koji, Shibasaki, Yoshiyuki, Tachikawa, Sayaka, Tsubouchi, Hidetsugu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Japan 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5281662/
https://www.ncbi.nlm.nih.gov/pubmed/27379386
http://dx.doi.org/10.1007/s00535-016-1233-x
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author Sakaida, Isao
Terai, Shuji
Nakajima, Koji
Shibasaki, Yoshiyuki
Tachikawa, Sayaka
Tsubouchi, Hidetsugu
author_facet Sakaida, Isao
Terai, Shuji
Nakajima, Koji
Shibasaki, Yoshiyuki
Tachikawa, Sayaka
Tsubouchi, Hidetsugu
author_sort Sakaida, Isao
collection PubMed
description 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 <500 mL. None of the patients with initial urine volume of <500 mL showed resolution of symptoms. CONCLUSIONS: Change in urine volume was affected by both baseline body weight and BUN in tolvaptan-treated subjects. Higher urine output was associated with improvements in ascites-related clinical symptoms.
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spelling pubmed-52816622017-02-13 Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis Sakaida, Isao Terai, Shuji Nakajima, Koji Shibasaki, Yoshiyuki Tachikawa, Sayaka Tsubouchi, Hidetsugu J Gastroenterol Original Article—Liver, Pancreas, and Biliary Tract 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 <500 mL. None of the patients with initial urine volume of <500 mL showed resolution of symptoms. CONCLUSIONS: Change in urine volume was affected by both baseline body weight and BUN in tolvaptan-treated subjects. Higher urine output was associated with improvements in ascites-related clinical symptoms. Springer Japan 2016-07-05 2017 /pmc/articles/PMC5281662/ /pubmed/27379386 http://dx.doi.org/10.1007/s00535-016-1233-x Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article—Liver, Pancreas, and Biliary Tract
Sakaida, Isao
Terai, Shuji
Nakajima, Koji
Shibasaki, Yoshiyuki
Tachikawa, Sayaka
Tsubouchi, Hidetsugu
Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title_full Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title_fullStr Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title_full_unstemmed Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title_short Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
title_sort predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis
topic Original Article—Liver, Pancreas, and Biliary Tract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5281662/
https://www.ncbi.nlm.nih.gov/pubmed/27379386
http://dx.doi.org/10.1007/s00535-016-1233-x
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