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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 that...
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| Published in: | Journal of gastroenterology 2017-02, Vol.52 (2), p.229-236 |
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| container_end_page | 236 |
| container_issue | 2 |
| container_start_page | 229 |
| container_title | Journal of gastroenterology |
| container_volume | 52 |
| creator | Sakaida, Isao Terai, Shuji Nakajima, Koji Shibasaki, Yoshiyuki Tachikawa, Sayaka Tsubouchi, Hidetsugu |
| 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 |
| doi_str_mv | 10.1007/s00535-016-1233-x |
| format | article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5281662</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A714583760</galeid><sourcerecordid>A714583760</sourcerecordid><originalsourceid>FETCH-LOGICAL-c528t-373946cc866266fd024224ff4f3a81456601082ea7e095e0d2fdaafd38a8350c3</originalsourceid><addsrcrecordid>eNp1UU1rFTEUDaLYZ_UHuJGA66k3ySSTcSGU4hcUdKHrcM0kb1JmJmOS99r-e1NfrS0oWQTu-bjncgh5yeCEAXRvMoAUsgGmGsaFaK4ekQ1r60T2nD8mG-jbtmGsa4_Is5wvAJgAqZ-SI96JrhdabUj-mtwQbAl7Rz3aElOm0dMyOrqOmGa0cYrbYHGiFQ1x-Y3GaY9rwYWGha5YgltKppehjHSqRonakNIYc8hvKdI15kLHaCkuOF3X4XPyxOOU3Yvb_5h8__D-29mn5vzLx89np-eNlVyXRnSib5W1WimulB-At5y33rdeoGatVAoYaO6wc9BLBwP3A6IfhEYtJFhxTN4dfNfdj9kNtqZMOJk1hRnTtYkYzENkCaPZxr2p61ldWg1e3xqk-HPncjEXcZfqFdkwrSSXHfTsL2uLkzNh8bGa2Tlka067mlOLTkFlnfyDVd_g5mDj4nyo8wcCdhDYFHNOzt8FZ2Bu6jeH-k2t39zUb66q5tX9i-8Uf_quBH4g5AotW5fuXfRf1184tLwY</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1865257091</pqid></control><display><type>article</type><title>Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis</title><source>Springer Nature</source><creator>Sakaida, Isao ; Terai, Shuji ; Nakajima, Koji ; Shibasaki, Yoshiyuki ; Tachikawa, Sayaka ; Tsubouchi, Hidetsugu</creator><creatorcontrib>Sakaida, Isao ; Terai, Shuji ; Nakajima, Koji ; Shibasaki, Yoshiyuki ; Tachikawa, Sayaka ; Tsubouchi, Hidetsugu</creatorcontrib><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.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-016-1233-x</identifier><identifier>PMID: 27379386</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>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</subject><ispartof>Journal of gastroenterology, 2017-02, Vol.52 (2), p.229-236</ispartof><rights>The Author(s) 2016</rights><rights>COPYRIGHT 2017 Springer</rights><rights>Journal of Gastroenterology is a copyright of Springer, 2017.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c528t-373946cc866266fd024224ff4f3a81456601082ea7e095e0d2fdaafd38a8350c3</citedby><cites>FETCH-LOGICAL-c528t-373946cc866266fd024224ff4f3a81456601082ea7e095e0d2fdaafd38a8350c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27379386$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sakaida, Isao</creatorcontrib><creatorcontrib>Terai, Shuji</creatorcontrib><creatorcontrib>Nakajima, Koji</creatorcontrib><creatorcontrib>Shibasaki, Yoshiyuki</creatorcontrib><creatorcontrib>Tachikawa, Sayaka</creatorcontrib><creatorcontrib>Tsubouchi, Hidetsugu</creatorcontrib><title>Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><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.</description><subject>Abdominal Surgery</subject><subject>Aged</subject><subject>Analysis</subject><subject>Antidiuretic Hormone Receptor Antagonists - pharmacology</subject><subject>Antidiuretic Hormone Receptor Antagonists - therapeutic use</subject><subject>Ascites - drug therapy</subject><subject>Ascites - pathology</subject><subject>Benzazepines - pharmacology</subject><subject>Benzazepines - therapeutic use</subject><subject>Biliary Tract</subject><subject>Blood Urea Nitrogen</subject><subject>Body Weight</subject><subject>Care and treatment</subject><subject>Colorectal Surgery</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Japan</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Cirrhosis - pathology</subject><subject>Male</subject><subject>Medical colleges</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Original Article—Liver</subject><subject>Original —Liver, Pancreas, and Biliary Tract</subject><subject>Pancreas</subject><subject>Predictive Value of Tests</subject><subject>Surgical Oncology</subject><subject>Urine</subject><issn>0944-1174</issn><issn>1435-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1UU1rFTEUDaLYZ_UHuJGA66k3ySSTcSGU4hcUdKHrcM0kb1JmJmOS99r-e1NfrS0oWQTu-bjncgh5yeCEAXRvMoAUsgGmGsaFaK4ekQ1r60T2nD8mG-jbtmGsa4_Is5wvAJgAqZ-SI96JrhdabUj-mtwQbAl7Rz3aElOm0dMyOrqOmGa0cYrbYHGiFQ1x-Y3GaY9rwYWGha5YgltKppehjHSqRonakNIYc8hvKdI15kLHaCkuOF3X4XPyxOOU3Yvb_5h8__D-29mn5vzLx89np-eNlVyXRnSib5W1WimulB-At5y33rdeoGatVAoYaO6wc9BLBwP3A6IfhEYtJFhxTN4dfNfdj9kNtqZMOJk1hRnTtYkYzENkCaPZxr2p61ldWg1e3xqk-HPncjEXcZfqFdkwrSSXHfTsL2uLkzNh8bGa2Tlka067mlOLTkFlnfyDVd_g5mDj4nyo8wcCdhDYFHNOzt8FZ2Bu6jeH-k2t39zUb66q5tX9i-8Uf_quBH4g5AotW5fuXfRf1184tLwY</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Sakaida, Isao</creator><creator>Terai, Shuji</creator><creator>Nakajima, Koji</creator><creator>Shibasaki, Yoshiyuki</creator><creator>Tachikawa, Sayaka</creator><creator>Tsubouchi, Hidetsugu</creator><general>Springer Japan</general><general>Springer</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20170201</creationdate><title>Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis</title><author>Sakaida, Isao ; Terai, Shuji ; Nakajima, Koji ; Shibasaki, Yoshiyuki ; Tachikawa, Sayaka ; Tsubouchi, Hidetsugu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c528t-373946cc866266fd024224ff4f3a81456601082ea7e095e0d2fdaafd38a8350c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Abdominal Surgery</topic><topic>Aged</topic><topic>Analysis</topic><topic>Antidiuretic Hormone Receptor Antagonists - pharmacology</topic><topic>Antidiuretic Hormone Receptor Antagonists - therapeutic use</topic><topic>Ascites - drug therapy</topic><topic>Ascites - pathology</topic><topic>Benzazepines - pharmacology</topic><topic>Benzazepines - therapeutic use</topic><topic>Biliary Tract</topic><topic>Blood Urea Nitrogen</topic><topic>Body Weight</topic><topic>Care and treatment</topic><topic>Colorectal Surgery</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Japan</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Cirrhosis - pathology</topic><topic>Male</topic><topic>Medical colleges</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Original Article—Liver</topic><topic>Original —Liver, Pancreas, and Biliary Tract</topic><topic>Pancreas</topic><topic>Predictive Value of Tests</topic><topic>Surgical Oncology</topic><topic>Urine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sakaida, Isao</creatorcontrib><creatorcontrib>Terai, Shuji</creatorcontrib><creatorcontrib>Nakajima, Koji</creatorcontrib><creatorcontrib>Shibasaki, Yoshiyuki</creatorcontrib><creatorcontrib>Tachikawa, Sayaka</creatorcontrib><creatorcontrib>Tsubouchi, Hidetsugu</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Complete (ProQuest Database)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sakaida, Isao</au><au>Terai, Shuji</au><au>Nakajima, Koji</au><au>Shibasaki, Yoshiyuki</au><au>Tachikawa, Sayaka</au><au>Tsubouchi, Hidetsugu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>52</volume><issue>2</issue><spage>229</spage><epage>236</epage><pages>229-236</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><abstract>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.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>27379386</pmid><doi>10.1007/s00535-016-1233-x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| source | Springer Nature |
| 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 |
| title | Predictive factors of the pharmacological action of tolvaptan in patients with liver cirrhosis: a post hoc analysis |
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