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Efficacy and Safety of Everolimus With Reduced Tacrolimus in Liver Transplant Recipients: 24-month Results From the Pooled Analysis of 2 Randomized Controlled Trials
DC Field | Value | Language |
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dc.contributor.author | 주동진 | - |
dc.date.accessioned | 2021-12-28T17:43:13Z | - |
dc.date.available | 2021-12-28T17:43:13Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 0041-1337 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/187238 | - |
dc.description.abstract | Background and methods: Data from 2 randomized liver transplant trials (N = 772; H2304 [deceased donor, n = 488], H2307 [living donor, n = 284]) were pooled to further evaluate the efficacy and safety of everolimus with reduced tacrolimus (EVR + rTAC) versus standard tacrolimus (sTAC) regimen at month 24. Results: EVR + rTAC was comparable to sTAC for composite efficacy failure of treated biopsy-proven acute rejection, graft loss, or death (9.8% versus 10.8%; difference, -1.0%; 95% confidence interval, -5.4 to 3.4; P = 0.641) at month 24. EVR + rTAC was superior to sTAC for the mean change in estimated glomerular filtration rate (eGFR) from randomization to month 24 (-8.37 versus -13.40 mL/min/1.73 m2; P = 0.001). A subanalysis of renal function by chronic kidney disease (CKD) stage at randomization showed significantly lower decline in eGFR from randomization to month 24 for patients with CKD stage 1/2 (eGFR ≥ 60 mL/min/1.73 m2) in EVR + rTAC group versus sTAC (-12.82 versus -17.67 mL/min/1.73 m2, P = 0.009). In patients transplanted for hepatocellular carcinoma (HCC) beyond Milan criteria, HCC recurrence was numerically lower although not statistically significant with EVR + rTAC versus sTAC group (5.9% [1 of 17] versus 23.1% [6 of 26], P = 0.215), while comparable in patients within Milan criteria (2.9% [3 of 102] versus 2.1% [2 of 96], P = 1.000), irrespective of pretransplant alpha-fetoprotein levels. Conclusions: EVR + rTAC versus sTAC showed comparable efficacy and safety with significantly better renal function, particularly in patients with normal/mildly decreased renal function (CKD stage 1/2) at randomization and a trend toward lower HCC recurrence in patients transplanted with HCC beyond Milan at month 24. Further long-term data would be required to confirm these results. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isPartOf | TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Calcineurin Inhibitors / administration & dosage* | - |
dc.subject.MESH | Calcineurin Inhibitors / adverse effects | - |
dc.subject.MESH | Carcinoma, Hepatocellular / diagnosis | - |
dc.subject.MESH | Carcinoma, Hepatocellular / surgery* | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Everolimus / administration & dosage* | - |
dc.subject.MESH | Everolimus / adverse effects | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glomerular Filtration Rate / drug effects | - |
dc.subject.MESH | Graft Rejection / diagnosis | - |
dc.subject.MESH | Graft Rejection / immunology | - |
dc.subject.MESH | Graft Rejection / prevention & control* | - |
dc.subject.MESH | Graft Survival / drug effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunosuppressive Agents / administration & dosage* | - |
dc.subject.MESH | Immunosuppressive Agents / adverse effects | - |
dc.subject.MESH | Kidney / drug effects | - |
dc.subject.MESH | Kidney / physiopathology | - |
dc.subject.MESH | Liver Neoplasms / diagnosis | - |
dc.subject.MESH | Liver Neoplasms / surgery* | - |
dc.subject.MESH | Liver Transplantation* / adverse effects | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Randomized Controlled Trials as Topic | - |
dc.subject.MESH | Recurrence | - |
dc.subject.MESH | Tacrolimus / administration & dosage* | - |
dc.subject.MESH | Tacrolimus / adverse effects | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Efficacy and Safety of Everolimus With Reduced Tacrolimus in Liver Transplant Recipients: 24-month Results From the Pooled Analysis of 2 Randomized Controlled Trials | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학교실) | - |
dc.contributor.googleauthor | Sung-Gyu Lee | - |
dc.contributor.googleauthor | Long-Bin Jeng | - |
dc.contributor.googleauthor | Faouzi Saliba | - |
dc.contributor.googleauthor | Arvinder Singh Soin | - |
dc.contributor.googleauthor | Wei-Chen Lee | - |
dc.contributor.googleauthor | Paolo De Simone | - |
dc.contributor.googleauthor | Frederik Nevens | - |
dc.contributor.googleauthor | Kyung-Suk Suh | - |
dc.contributor.googleauthor | Lutz Fischer | - |
dc.contributor.googleauthor | Dong Jin Joo | - |
dc.contributor.googleauthor | John Fung | - |
dc.contributor.googleauthor | Jae-Won Joh | - |
dc.contributor.googleauthor | Toshimi Kaido | - |
dc.contributor.googleauthor | David Grant | - |
dc.contributor.googleauthor | Matthias Meier | - |
dc.contributor.googleauthor | Barbara Rauer | - |
dc.contributor.googleauthor | Carole Sips | - |
dc.contributor.googleauthor | Shuhei Kaneko | - |
dc.contributor.googleauthor | Gary Levy | - |
dc.identifier.doi | 10.1097/TP.0000000000003394 | - |
dc.contributor.localId | A03948 | - |
dc.relation.journalcode | J02754 | - |
dc.identifier.eissn | 1534-6080 | - |
dc.identifier.pmid | 33741847 | - |
dc.contributor.alternativeName | Joo, Dong Jin | - |
dc.contributor.affiliatedAuthor | 주동진 | - |
dc.citation.volume | 105 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 1564 | - |
dc.citation.endPage | 1575 | - |
dc.identifier.bibliographicCitation | TRANSPLANTATION, Vol.105(7) : 1564-1575, 2021-07 | - |
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