Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients
Background Biochemical response to ursodeoxycholic acid among patients with primary biliary cirrhosis remains variable, and there is no agreement of an ideal model. Novel assessment of response coupled to histologic progression was recently defined by the Toronto criteria. We retrospectively assesse...
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| Veröffentlicht in: | Journal of gastroenterology 2014-10, Vol.49 (10), p.1414-1420 |
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| creator | Lammert, Craig Juran, Brian D. Schlicht, Erik Chan, Landon L. Atkinson, Elizabeth J. de Andrade, Mariza Lazaridis, Konstantinos N. |
| description | Background
Biochemical response to ursodeoxycholic acid among patients with primary biliary cirrhosis remains variable, and there is no agreement of an ideal model. Novel assessment of response coupled to histologic progression was recently defined by the Toronto criteria. We retrospectively assessed transplant-free survival and clinical outcomes associated with ursodeoxycholic acid response to evaluate the Toronto criteria using a large North American cohort of PBC patients.
Methods
Three hundred and ninety-eight PBC patients from the Mayo Clinic PBC Genetic Epidemiology Registry were assessed for ursodeoxycholic acid treatment and biochemical response per the Toronto criteria. Responders were defined by reduction in alkaline phosphatase to less than or equal to 1.67 times the upper normal limit by 2 years of treatment, whereas non-responders had alkaline phosphatase values greater than 1.67 times the upper normal limit. Probability of survival was estimated using the Kaplan–Meier method.
Results
Three hundred and two (76 %) patients were responders and 96 (24 %) were non-responders. Significantly more non-responders developed adverse events related to chronic liver disease compared to responders (hazard ratio (HR) 2.77,
P
= 0.001). Biochemical responders and early-stage disease at treatment start was associated with improved overall transplant-free survival compared to non-responders (HR 1.9) and patients with late-stage disease (HR 2.7) after age and sex adjustment.
Conclusions
The Toronto criteria are capable of identifying ursodeoxycholic acid-treated primary biliary cirrhosis patients at risk of poor transplant-free survival and adverse clinical outcomes. Our data reveal that despite advanced disease at diagnosis, biochemical response per the Toronto criteria associates with improved overall transplant-free survival. |
| doi_str_mv | 10.1007/s00535-013-0903-1 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4048793</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A714584110</galeid><sourcerecordid>A714584110</sourcerecordid><originalsourceid>FETCH-LOGICAL-c631t-ad9b62a2b06c153910a3bf0689b183b19ac4f7e52a661ebb6852be49e4069f6f3</originalsourceid><addsrcrecordid>eNp1Uk2LFDEQDaK44-oP8CIBz72mOh_duQjj4hcsetFzSNLp6SzdnTHpGXZP_nVrmHGZBSWHgqr3XqrqFSGvgV0BY827wpjksmLAK6YZr-AJWYHAjNR1_ZSsmBaiAmjEBXlRyi1DIJPtc3JRCw6N5nJFfn-IyQ9hit6ONIeyTXMJdEl0l0vqQrq790Mao6fWx45uc-iiXwotu7yPe6TEmVr6LeVloOspZJSZqU8DJmjqER8nm--pi2M8RB9zHlKJhW7tEsO8lJfkWW_HEl6d4iX5-enjj-sv1c33z1-v1zeVVxyWynbaqdrWjikPkmtglrueqVY7aLkDbb3omyBrqxQE51QraxeEDoIp3aueX5L3R93tzk2h8_h3tqM5NWiSjeZxZY6D2aS9EUy0uCoUeHsSyOnXLpTF3KZdnrFnA7JVuH8hzlAbOwYT5z6hmJ9i8WbdgJCtAGCIuvoHCl93MCLNoY-Yf0SAI8HnVEoO_UPjwMzhFMzxFAw6bA6nYAA5b84nfmD89R4B9RFQsDRvQj6b6L-qfwCnfMC6</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1586090443</pqid></control><display><type>article</type><title>Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Lammert, Craig ; Juran, Brian D. ; Schlicht, Erik ; Chan, Landon L. ; Atkinson, Elizabeth J. ; de Andrade, Mariza ; Lazaridis, Konstantinos N.</creator><creatorcontrib>Lammert, Craig ; Juran, Brian D. ; Schlicht, Erik ; Chan, Landon L. ; Atkinson, Elizabeth J. ; de Andrade, Mariza ; Lazaridis, Konstantinos N.</creatorcontrib><description>Background
Biochemical response to ursodeoxycholic acid among patients with primary biliary cirrhosis remains variable, and there is no agreement of an ideal model. Novel assessment of response coupled to histologic progression was recently defined by the Toronto criteria. We retrospectively assessed transplant-free survival and clinical outcomes associated with ursodeoxycholic acid response to evaluate the Toronto criteria using a large North American cohort of PBC patients.
Methods
Three hundred and ninety-eight PBC patients from the Mayo Clinic PBC Genetic Epidemiology Registry were assessed for ursodeoxycholic acid treatment and biochemical response per the Toronto criteria. Responders were defined by reduction in alkaline phosphatase to less than or equal to 1.67 times the upper normal limit by 2 years of treatment, whereas non-responders had alkaline phosphatase values greater than 1.67 times the upper normal limit. Probability of survival was estimated using the Kaplan–Meier method.
Results
Three hundred and two (76 %) patients were responders and 96 (24 %) were non-responders. Significantly more non-responders developed adverse events related to chronic liver disease compared to responders (hazard ratio (HR) 2.77,
P
= 0.001). Biochemical responders and early-stage disease at treatment start was associated with improved overall transplant-free survival compared to non-responders (HR 1.9) and patients with late-stage disease (HR 2.7) after age and sex adjustment.
Conclusions
The Toronto criteria are capable of identifying ursodeoxycholic acid-treated primary biliary cirrhosis patients at risk of poor transplant-free survival and adverse clinical outcomes. Our data reveal that despite advanced disease at diagnosis, biochemical response per the Toronto criteria associates with improved overall transplant-free survival.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-013-0903-1</identifier><identifier>PMID: 24317935</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Abdominal Surgery ; Alkaline Phosphatase - blood ; Biliary cirrhosis ; Biliary Tract ; Biomarkers - blood ; Cholagogues and Choleretics - adverse effects ; Cholagogues and Choleretics - therapeutic use ; Clinical Enzyme Tests - methods ; Cohort Studies ; Colorectal Surgery ; Epidemiology ; Female ; Gastroenterology ; Hepatology ; Humans ; Kaplan-Meier Estimate ; Liver ; Liver Cirrhosis, Biliary - diagnosis ; Liver Cirrhosis, Biliary - drug therapy ; Male ; Medical colleges ; Medical research ; Medicine ; Medicine & Public Health ; Medicine, Experimental ; Middle Aged ; Original Article—Liver ; Pancreas ; Patient outcomes ; Phosphatases ; Prognosis ; Pruritus - chemically induced ; Retrospective Studies ; Surgical Oncology ; Treatment Outcome ; Ursodeoxycholic Acid - adverse effects ; Ursodeoxycholic Acid - therapeutic use ; Ursodiol</subject><ispartof>Journal of gastroenterology, 2014-10, Vol.49 (10), p.1414-1420</ispartof><rights>Springer Japan 2013</rights><rights>COPYRIGHT 2014 Springer</rights><rights>Springer Japan 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c631t-ad9b62a2b06c153910a3bf0689b183b19ac4f7e52a661ebb6852be49e4069f6f3</citedby><cites>FETCH-LOGICAL-c631t-ad9b62a2b06c153910a3bf0689b183b19ac4f7e52a661ebb6852be49e4069f6f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00535-013-0903-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00535-013-0903-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24317935$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lammert, Craig</creatorcontrib><creatorcontrib>Juran, Brian D.</creatorcontrib><creatorcontrib>Schlicht, Erik</creatorcontrib><creatorcontrib>Chan, Landon L.</creatorcontrib><creatorcontrib>Atkinson, Elizabeth J.</creatorcontrib><creatorcontrib>de Andrade, Mariza</creatorcontrib><creatorcontrib>Lazaridis, Konstantinos N.</creatorcontrib><title>Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><description>Background
Biochemical response to ursodeoxycholic acid among patients with primary biliary cirrhosis remains variable, and there is no agreement of an ideal model. Novel assessment of response coupled to histologic progression was recently defined by the Toronto criteria. We retrospectively assessed transplant-free survival and clinical outcomes associated with ursodeoxycholic acid response to evaluate the Toronto criteria using a large North American cohort of PBC patients.
Methods
Three hundred and ninety-eight PBC patients from the Mayo Clinic PBC Genetic Epidemiology Registry were assessed for ursodeoxycholic acid treatment and biochemical response per the Toronto criteria. Responders were defined by reduction in alkaline phosphatase to less than or equal to 1.67 times the upper normal limit by 2 years of treatment, whereas non-responders had alkaline phosphatase values greater than 1.67 times the upper normal limit. Probability of survival was estimated using the Kaplan–Meier method.
Results
Three hundred and two (76 %) patients were responders and 96 (24 %) were non-responders. Significantly more non-responders developed adverse events related to chronic liver disease compared to responders (hazard ratio (HR) 2.77,
P
= 0.001). Biochemical responders and early-stage disease at treatment start was associated with improved overall transplant-free survival compared to non-responders (HR 1.9) and patients with late-stage disease (HR 2.7) after age and sex adjustment.
Conclusions
The Toronto criteria are capable of identifying ursodeoxycholic acid-treated primary biliary cirrhosis patients at risk of poor transplant-free survival and adverse clinical outcomes. Our data reveal that despite advanced disease at diagnosis, biochemical response per the Toronto criteria associates with improved overall transplant-free survival.</description><subject>Abdominal Surgery</subject><subject>Alkaline Phosphatase - blood</subject><subject>Biliary cirrhosis</subject><subject>Biliary Tract</subject><subject>Biomarkers - blood</subject><subject>Cholagogues and Choleretics - adverse effects</subject><subject>Cholagogues and Choleretics - therapeutic use</subject><subject>Clinical Enzyme Tests - methods</subject><subject>Cohort Studies</subject><subject>Colorectal Surgery</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Liver</subject><subject>Liver Cirrhosis, Biliary - diagnosis</subject><subject>Liver Cirrhosis, Biliary - drug therapy</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>Pancreas</subject><subject>Patient outcomes</subject><subject>Phosphatases</subject><subject>Prognosis</subject><subject>Pruritus - chemically induced</subject><subject>Retrospective Studies</subject><subject>Surgical Oncology</subject><subject>Treatment Outcome</subject><subject>Ursodeoxycholic Acid - adverse effects</subject><subject>Ursodeoxycholic Acid - therapeutic use</subject><subject>Ursodiol</subject><issn>0944-1174</issn><issn>1435-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1Uk2LFDEQDaK44-oP8CIBz72mOh_duQjj4hcsetFzSNLp6SzdnTHpGXZP_nVrmHGZBSWHgqr3XqrqFSGvgV0BY827wpjksmLAK6YZr-AJWYHAjNR1_ZSsmBaiAmjEBXlRyi1DIJPtc3JRCw6N5nJFfn-IyQ9hit6ONIeyTXMJdEl0l0vqQrq790Mao6fWx45uc-iiXwotu7yPe6TEmVr6LeVloOspZJSZqU8DJmjqER8nm--pi2M8RB9zHlKJhW7tEsO8lJfkWW_HEl6d4iX5-enjj-sv1c33z1-v1zeVVxyWynbaqdrWjikPkmtglrueqVY7aLkDbb3omyBrqxQE51QraxeEDoIp3aueX5L3R93tzk2h8_h3tqM5NWiSjeZxZY6D2aS9EUy0uCoUeHsSyOnXLpTF3KZdnrFnA7JVuH8hzlAbOwYT5z6hmJ9i8WbdgJCtAGCIuvoHCl93MCLNoY-Yf0SAI8HnVEoO_UPjwMzhFMzxFAw6bA6nYAA5b84nfmD89R4B9RFQsDRvQj6b6L-qfwCnfMC6</recordid><startdate>20141001</startdate><enddate>20141001</enddate><creator>Lammert, Craig</creator><creator>Juran, Brian D.</creator><creator>Schlicht, Erik</creator><creator>Chan, Landon L.</creator><creator>Atkinson, Elizabeth J.</creator><creator>de Andrade, Mariza</creator><creator>Lazaridis, Konstantinos N.</creator><general>Springer Japan</general><general>Springer</general><general>Springer Nature B.V</general><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>20141001</creationdate><title>Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients</title><author>Lammert, Craig ; Juran, Brian D. ; Schlicht, Erik ; Chan, Landon L. ; Atkinson, Elizabeth J. ; de Andrade, Mariza ; Lazaridis, Konstantinos N.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c631t-ad9b62a2b06c153910a3bf0689b183b19ac4f7e52a661ebb6852be49e4069f6f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Abdominal Surgery</topic><topic>Alkaline Phosphatase - blood</topic><topic>Biliary cirrhosis</topic><topic>Biliary Tract</topic><topic>Biomarkers - blood</topic><topic>Cholagogues and Choleretics - adverse effects</topic><topic>Cholagogues and Choleretics - therapeutic use</topic><topic>Clinical Enzyme Tests - methods</topic><topic>Cohort Studies</topic><topic>Colorectal Surgery</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Liver</topic><topic>Liver Cirrhosis, Biliary - diagnosis</topic><topic>Liver Cirrhosis, Biliary - drug therapy</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>Pancreas</topic><topic>Patient outcomes</topic><topic>Phosphatases</topic><topic>Prognosis</topic><topic>Pruritus - chemically induced</topic><topic>Retrospective Studies</topic><topic>Surgical Oncology</topic><topic>Treatment Outcome</topic><topic>Ursodeoxycholic Acid - adverse effects</topic><topic>Ursodeoxycholic Acid - therapeutic use</topic><topic>Ursodiol</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lammert, Craig</creatorcontrib><creatorcontrib>Juran, Brian D.</creatorcontrib><creatorcontrib>Schlicht, Erik</creatorcontrib><creatorcontrib>Chan, Landon L.</creatorcontrib><creatorcontrib>Atkinson, Elizabeth J.</creatorcontrib><creatorcontrib>de Andrade, Mariza</creatorcontrib><creatorcontrib>Lazaridis, Konstantinos N.</creatorcontrib><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 Collection</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 Edition)</collection><collection>ProQuest Central UK/Ireland</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>Lammert, Craig</au><au>Juran, Brian D.</au><au>Schlicht, Erik</au><au>Chan, Landon L.</au><au>Atkinson, Elizabeth J.</au><au>de Andrade, Mariza</au><au>Lazaridis, Konstantinos N.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2014-10-01</date><risdate>2014</risdate><volume>49</volume><issue>10</issue><spage>1414</spage><epage>1420</epage><pages>1414-1420</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><abstract>Background
Biochemical response to ursodeoxycholic acid among patients with primary biliary cirrhosis remains variable, and there is no agreement of an ideal model. Novel assessment of response coupled to histologic progression was recently defined by the Toronto criteria. We retrospectively assessed transplant-free survival and clinical outcomes associated with ursodeoxycholic acid response to evaluate the Toronto criteria using a large North American cohort of PBC patients.
Methods
Three hundred and ninety-eight PBC patients from the Mayo Clinic PBC Genetic Epidemiology Registry were assessed for ursodeoxycholic acid treatment and biochemical response per the Toronto criteria. Responders were defined by reduction in alkaline phosphatase to less than or equal to 1.67 times the upper normal limit by 2 years of treatment, whereas non-responders had alkaline phosphatase values greater than 1.67 times the upper normal limit. Probability of survival was estimated using the Kaplan–Meier method.
Results
Three hundred and two (76 %) patients were responders and 96 (24 %) were non-responders. Significantly more non-responders developed adverse events related to chronic liver disease compared to responders (hazard ratio (HR) 2.77,
P
= 0.001). Biochemical responders and early-stage disease at treatment start was associated with improved overall transplant-free survival compared to non-responders (HR 1.9) and patients with late-stage disease (HR 2.7) after age and sex adjustment.
Conclusions
The Toronto criteria are capable of identifying ursodeoxycholic acid-treated primary biliary cirrhosis patients at risk of poor transplant-free survival and adverse clinical outcomes. Our data reveal that despite advanced disease at diagnosis, biochemical response per the Toronto criteria associates with improved overall transplant-free survival.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>24317935</pmid><doi>10.1007/s00535-013-0903-1</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0944-1174 |
| ispartof | Journal of gastroenterology, 2014-10, Vol.49 (10), p.1414-1420 |
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| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Abdominal Surgery Alkaline Phosphatase - blood Biliary cirrhosis Biliary Tract Biomarkers - blood Cholagogues and Choleretics - adverse effects Cholagogues and Choleretics - therapeutic use Clinical Enzyme Tests - methods Cohort Studies Colorectal Surgery Epidemiology Female Gastroenterology Hepatology Humans Kaplan-Meier Estimate Liver Liver Cirrhosis, Biliary - diagnosis Liver Cirrhosis, Biliary - drug therapy Male Medical colleges Medical research Medicine Medicine & Public Health Medicine, Experimental Middle Aged Original Article—Liver Pancreas Patient outcomes Phosphatases Prognosis Pruritus - chemically induced Retrospective Studies Surgical Oncology Treatment Outcome Ursodeoxycholic Acid - adverse effects Ursodeoxycholic Acid - therapeutic use Ursodiol |
| title | Biochemical response to ursodeoxycholic acid predicts survival in a North American cohort of primary biliary cirrhosis patients |
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