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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Japan
2016
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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. |
format | Online Article Text |
id | pubmed-5281662 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
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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