{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T17:52:39Z","timestamp":1782409959565,"version":"3.54.5"},"reference-count":12,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2011,12,4]],"date-time":"2011-12-04T00:00:00Z","timestamp":1322956800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2012,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Biochemical tests have been recommended as endpoints for clinical trials in primary biliary cirrhosis (<jats:styled-content style=\"fixed-case\">PBC<\/jats:styled-content>) because the use of liver transplantation and death as endpoints in ursodeoxycholic acid (<jats:styled-content style=\"fixed-case\">UDCA<\/jats:styled-content>) therapeutic trials is unfeasible. The best inclusion criteria cut\u2010off values and cut\u2010off for demonstrating treatment success have not been defined.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>Our aim was to determine the optimal biochemical values for patient inclusion and to define values for treatment success in therapeutic trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a retrospective review of 73 patients with <jats:styled-content style=\"fixed-case\">PBC<\/jats:styled-content> treated with <jats:styled-content style=\"fixed-case\">UDCA<\/jats:styled-content> followed over 36\u00a0months. Following one year of <jats:styled-content style=\"fixed-case\">UDCA<\/jats:styled-content> therapy, the likelihood of developing clinical endpoints of varices, ascites, encephalopathy, death or transplantation over the ensuing two years, based on degrees of elevation of biochemical markers, was analyzed using chi\u2010square or Fisher's exact test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Patients with ALP\u22652 X upper limit of normal (ULN) had a 2\u2010fold greater likelihood of developing endpoints compared to patients with lower values (23% versus 11%), (p\u00a0&lt;\u00a00.05). Patients with bilirubin\u00a0&gt;\u00a01\u00a0mg\/<jats:styled-content style=\"fixed-case\">dL<\/jats:styled-content> were 4 times more likely to develop endpoints compared to those with lower values (33% versus 8%), (p\u00a0=\u00a00.02). These values help identify the patient population for adjunctive therapy trials. Patients with ALP \u22641.67 X ULN and bilirubin \u22641mg\/<jats:styled-content style=\"fixed-case\">dL<\/jats:styled-content> demonstrated the least likelihood of reaching adverse clinical endpoints and can be used to define treatment success.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Optimal <jats:styled-content style=\"fixed-case\">ALP<\/jats:styled-content> and Bilirubin levels can be used as appropriate biochemical criteria for patient selection and defining treatment success in future clinical trials in patients with <jats:styled-content style=\"fixed-case\">PBC<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1478-3231.2011.02678.x","type":"journal-article","created":{"date-parts":[[2011,12,5]],"date-time":"2011-12-05T02:02:44Z","timestamp":1323050564000},"page":"790-795","source":"Crossref","is-referenced-by-count":74,"title":["Optimizing biochemical markers as endpoints for clinical trials in primary biliary cirrhosis"],"prefix":"10.1111","volume":"32","author":[{"given":"Njideka","family":"Momah","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Wright State University Dayton OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina G.","family":"Silveira","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta","family":"Jorgensen","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanouil","family":"Sinakos","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith D.","family":"Lindor","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Mayo Clinic Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,12,4]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199105303242204"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(94)90021-3"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.1840190512"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(97)70183-5"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2009.01.003"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.12.029"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.07.019"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22428"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23637"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.216"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1478-3231.1999.tb00020.x"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22906"}],"container-title":["Liver International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1478-3231.2011.02678.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1478-3231.2011.02678.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T04:21:38Z","timestamp":1698639698000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1478-3231.2011.02678.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,12,4]]},"references-count":12,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2012,5]]}},"alternative-id":["10.1111\/j.1478-3231.2011.02678.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1478-3231.2011.02678.x","archive":["Portico"],"relation":{},"ISSN":["1478-3223","1478-3231"],"issn-type":[{"value":"1478-3223","type":"print"},{"value":"1478-3231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,12,4]]}}}