{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:47:37Z","timestamp":1787014057725,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015217","name":"Veloxis Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015217","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Extended\u2010release tacrolimus for prophylaxis of allograft rejection in orthotopic heart transplant (OHT) recipients is currently not FDA\u2010approved. One such extended\u2010release formulation of tacrolimus known as LCPT allows once\u2010daily dosing and improves bioavailability compared to immediate\u2010release tacrolimus (IR\u2010tacrolimus). We compared the efficacy and safety of LCPT to IR\u2010tacrolimus applied\n                    <jats:italic>de novo<\/jats:italic>\n                    in adult OHT recipients. Twenty\u2010five prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR\u2010tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and\/or new graft dysfunction within 1\u00a0year was compared using non\u2010inferiority analysis. LCPT demonstrated non\u2010inferiority to IR\u2010tacrolimus, with a primary outcome risk reduction of 20% (90% CI: \u201040%, \u2010.5%; non\u2010inferiority\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0=\u00a0.001). Tacrolimus trough levels peaked at 2\u20133 months and were higher in LCPT (median 14.5\u00a0vs. 12.7\u00a0ng\/ml;\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0=\u00a0.03) with similar dose levels (LCPT vs. IR\u2010tacrolimus: .08\u00a0vs. .09\u00a0mg\/kg\/day;\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0=\u00a0.33). Cardiovascular\u2010related readmissions were reduced by 62% (\n                    <jats:italic>P<\/jats:italic>\n                    \u00a0=\u00a0.046) in LCPT patients. The complication rate per transplant admission and all\u2010cause readmission rate did not differ significantly. These results suggest that LCPT is non\u2010inferior in efficacy to IR\u2010tacrolimus with a similar safety profile and improved bioavailability in OHT.\n                  <\/jats:p>","DOI":"10.1111\/ctr.14487","type":"journal-article","created":{"date-parts":[[2021,9,16]],"date-time":"2021-09-16T09:01:50Z","timestamp":1631782910000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["<i>De novo<\/i>\n                    tacrolimus extended\u2010release tablets (LCPT) versus twice\u2010daily tacrolimus in adult heart transplantation: Results of a single\u2010center non\u2010inferiority matched control trial"],"prefix":"10.1111","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4205-9214","authenticated-orcid":false,"given":"Johanna S.","family":"van Zyl","sequence":"first","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9780-7227","authenticated-orcid":false,"given":"Teena","family":"Sam","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna M.","family":"Clark","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7200-8755","authenticated-orcid":false,"given":"Joost","family":"Felius","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda K.","family":"Doss","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kacie R.","family":"Kerlee","sequence":"additional","affiliation":[{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zi\u2010On","family":"Cheung","sequence":"additional","affiliation":[{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katalin","family":"Martits\u2010Chalangari","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9471-3383","authenticated-orcid":false,"given":"Aayla K.","family":"Jamil","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2225-1324","authenticated-orcid":false,"given":"Sandra A.","family":"Carey","sequence":"additional","affiliation":[{"name":"Center for Advanced Heart and Lung Disease Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8376-8709","authenticated-orcid":false,"given":"Robert L.","family":"Gottlieb","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"},{"name":"Center for Advanced Heart and Lung Disease Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Division of Precision Medicine Baylor University Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar Y.","family":"Guerrero\u2010Miranda","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"},{"name":"Center for Advanced Heart and Lung Disease Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parag","family":"Kale","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"},{"name":"Center for Advanced Heart and Lung Disease Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4894-396X","authenticated-orcid":false,"given":"Shelley A.","family":"Hall","sequence":"additional","affiliation":[{"name":"Baylor Scott &amp; White Research Institute Baylor Scott &amp; White Health  Dallas Texas USA"},{"name":"Texas A&amp;M University College of Medicine Health Science Center  Dallas Texas USA"},{"name":"Center for Advanced Heart and Lung Disease Baylor University Medical Center Baylor Scott &amp; White Health  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trim.2010.04.007"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2019.08.004"},{"key":"e_1_2_10_4_1","unstructured":"Astellas Pharma US Inc.Prograf (Tacrolimus) Capsules\/Injection [Package Insert].;2012. 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Accessed: January 8 2021.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/206406s007lbl.pdf"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.13903"}],"container-title":["Clinical Transplantation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.14487","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ctr.14487","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.14487","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T13:23:14Z","timestamp":1692969794000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ctr.14487"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10]]},"references-count":34,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["10.1111\/ctr.14487"],"URL":"https:\/\/doi.org\/10.1111\/ctr.14487","archive":["Portico"],"relation":{},"ISSN":["0902-0063","1399-0012"],"issn-type":[{"value":"0902-0063","type":"print"},{"value":"1399-0012","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10]]},"assertion":[{"value":"2021-06-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-09-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-10-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e14487"}}