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Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study

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dc.contributor.author주동진-
dc.date.accessioned2018-09-28T08:59:52Z-
dc.date.available2018-09-28T08:59:52Z-
dc.date.issued2018-
dc.identifier.issn1600-6135-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/163311-
dc.description.abstractIn a multicenter, open-label, study, 284 living-donor liver transplant patients were randomized at 30 ± 5 days posttransplant to start everolimus+reduced tacrolimus (EVR+rTAC) or continue standard tacrolimus (TAC Control). EVR+rTAC was non-inferior to TAC Control for the primary efficacy endpoint of treated BPAR, graft loss or death at 12 months posttransplant: difference -0.7% (90% CI -5.2%, 3.7%); P < .001 for non-inferiority. Treated BPAR occurred in 2.2% and 3.6% of patients, respectively. The key secondary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, achieved non-inferiority (P < .001 for non-inferiority), but not superiority and was similar between groups overall (mean -8.0 vs. -12.1 mL/min/1.73 m2 , P = .108), and in patients continuing randomized treatment (-8.0 vs. -13.3 mL/min/1.73 m2 , P = .046). In the EVR+rTAC and TAC control groups, study drug was discontinued in 15.5% and 17.6% of patients, adverse events with suspected relation to study drug occurred in 57.0% and 40.4%, and proteinuria ≥1 g/24 h in 9.3% and 0%, respectively. Everolimus did not negatively affect liver regeneration. At 12 months, hepatocellular recurrence was only seen in the standard TAC-treated patients (5/62; 8.1%). In conclusion, early introduction of EVR+rTAC was non-inferior to standard tacrolimus in terms of efficacy and renal function at 12 months, with hepatocellular carcinoma recurrence only in TAC Control patients. ClinicalTrials.gov Identifier: NCT01888432.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherWiley-Blackwell-
dc.relation.isPartOfAMERICAN JOURNAL OF TRANSPLANTATION-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleEfficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Surgery-
dc.contributor.googleauthorLong-Bin Jeng-
dc.contributor.googleauthorSung Gyu Lee-
dc.contributor.googleauthorArvinder Singh Soin-
dc.contributor.googleauthorWei-Chen Lee-
dc.contributor.googleauthorKyung-Suk Suh-
dc.contributor.googleauthorDong Jin Joo-
dc.contributor.googleauthorShinji Uemoto-
dc.contributor.googleauthorJaewon Joh-
dc.contributor.googleauthorTomoharu Yoshizumi-
dc.contributor.googleauthorHorng-Ren Yang-
dc.contributor.googleauthorGi-Won Song-
dc.contributor.googleauthorPatricia Lopez-
dc.contributor.googleauthorJossy Kochuparampil-
dc.contributor.googleauthorCarole Sips-
dc.contributor.googleauthorShuhei Kaneko-
dc.contributor.googleauthorGary Levy-
dc.identifier.doi10.1111/ajt.14623-
dc.contributor.localIdA03948-
dc.relation.journalcodeJ00121-
dc.identifier.eissn1600-6143-
dc.identifier.pmid29237235-
dc.identifier.urlhttps://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.14623-
dc.subject.keywordclinical research/practice-
dc.subject.keywordimmunosuppressant - mechanistic target of rapamycin (mTOR)-
dc.subject.keywordimmunosuppression/immune modulation-
dc.subject.keywordlung (allograft) function/dysfunction-
dc.contributor.alternativeNameJoo, Dong Jin-
dc.contributor.affiliatedAuthorJoo, Dong Jin-
dc.citation.volume18-
dc.citation.number6-
dc.citation.startPage1435-
dc.citation.endPage1446-
dc.identifier.bibliographicCitationAMERICAN JOURNAL OF TRANSPLANTATION, Vol.18(6) : 1435-1446, 2018-
dc.identifier.rimsid58575-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers

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