Cited 52 times in
Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study
DC Field | Value | Language |
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dc.contributor.author | 주동진 | - |
dc.date.accessioned | 2018-09-28T08:59:52Z | - |
dc.date.available | 2018-09-28T08:59:52Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1600-6135 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/163311 | - |
dc.description.abstract | In 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley-Blackwell | - |
dc.relation.isPartOf | AMERICAN JOURNAL OF TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Surgery | - |
dc.contributor.googleauthor | Long-Bin Jeng | - |
dc.contributor.googleauthor | Sung Gyu Lee | - |
dc.contributor.googleauthor | Arvinder Singh Soin | - |
dc.contributor.googleauthor | Wei-Chen Lee | - |
dc.contributor.googleauthor | Kyung-Suk Suh | - |
dc.contributor.googleauthor | Dong Jin Joo | - |
dc.contributor.googleauthor | Shinji Uemoto | - |
dc.contributor.googleauthor | Jaewon Joh | - |
dc.contributor.googleauthor | Tomoharu Yoshizumi | - |
dc.contributor.googleauthor | Horng-Ren Yang | - |
dc.contributor.googleauthor | Gi-Won Song | - |
dc.contributor.googleauthor | Patricia Lopez | - |
dc.contributor.googleauthor | Jossy Kochuparampil | - |
dc.contributor.googleauthor | Carole Sips | - |
dc.contributor.googleauthor | Shuhei Kaneko | - |
dc.contributor.googleauthor | Gary Levy | - |
dc.identifier.doi | 10.1111/ajt.14623 | - |
dc.contributor.localId | A03948 | - |
dc.relation.journalcode | J00121 | - |
dc.identifier.eissn | 1600-6143 | - |
dc.identifier.pmid | 29237235 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.14623 | - |
dc.subject.keyword | clinical research/practice | - |
dc.subject.keyword | immunosuppressant - mechanistic target of rapamycin (mTOR) | - |
dc.subject.keyword | immunosuppression/immune modulation | - |
dc.subject.keyword | lung (allograft) function/dysfunction | - |
dc.contributor.alternativeName | Joo, Dong Jin | - |
dc.contributor.affiliatedAuthor | Joo, Dong Jin | - |
dc.citation.volume | 18 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 1435 | - |
dc.citation.endPage | 1446 | - |
dc.identifier.bibliographicCitation | AMERICAN JOURNAL OF TRANSPLANTATION, Vol.18(6) : 1435-1446, 2018 | - |
dc.identifier.rimsid | 58575 | - |
dc.type.rims | ART | - |
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