Efficacy and safety of a switch from twice-daily tacrolimus to once-daily generic tacrolimus in stable liver transplant patients
DC Field | Value | Language |
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dc.contributor.author | 김종만 | - |
dc.contributor.author | 박평재 | - |
dc.contributor.author | 홍근 | - |
dc.contributor.author | 주동진 | - |
dc.contributor.author | 김관우 | - |
dc.contributor.author | 류제호 | - |
dc.contributor.author | 한영석 | - |
dc.contributor.author | 조재영 | - |
dc.contributor.author | 송기원 | - |
dc.contributor.author | 김봉완 | - |
dc.contributor.author | 김동식 | - |
dc.contributor.author | 김성훈 | - |
dc.contributor.author | 최상태 | - |
dc.contributor.author | 유영경 | - |
dc.contributor.author | 서경석 | - |
dc.contributor.author | 나양원 | - |
dc.contributor.author | 강구정 | - |
dc.contributor.author | 조재원 | - |
dc.date.accessioned | 2021-10-01T04:40:23Z | - |
dc.date.available | 2021-10-01T04:40:23Z | - |
dc.date.created | 2021-10-01 | - |
dc.date.issued | 2021-09 | - |
dc.identifier.issn | 2671-8790 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/82280 | - |
dc.description.abstract | Background: Once-daily tacrolimus reduces non-compliance relative to twice-daily tacrolimus. However, little is known about the safety and efficacy of conversion from twice-daily tacrolimus to generic once-daily tacrolimus in liver transplantation (LT). Herein, we investigated the efficacy and safety of a switch from twice-daily tacrolimus to generic once-daily tacrolimus in patients with stable liver graft function. Methods: This prospective, multicenter, open-label, single-arm study was conducted in 17 medical centers for 1 year from July 2019 to July 2020 (NCT04069065). Primary end- point was the incidence of biopsy-proven acute rejection (BPAR) for 24 weeks after con- version. Secondary endpoints were graft failure, patient death, and adverse events (AEs). Results: Of 151 screened LT patients, 144 patients were enrolled. BPAR, graft failure, and patient death did not occur in this patient population. There were no statistical dif- ferences in blood tests, liver function tests, or biochemical tests between visits in any of the patients. Median tacrolimus trough level decreased abruptly from 4.7 ng/mL to 3.2 ng/mL after generic once-daily tacrolimus conversion, but median tacrolimus dose in- creased due to low tacrolimus trough level. Ninety-two adverse events occurred in 54 pa- tients. Liver enzyme levels increased in seven patients (4.9%) after the switch to generic once-daily tacrolimus, but the liver function tests of these patients normalized thereafter. There were three cases of severe AEs not related to investigational drug. Conclusions: Present study suggests that conversion from twice-daily tacrolimus to ge- neric once-daily tacrolimus is effective and safe in stable LT patients. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | 대한이식학회 | - |
dc.relation.isPartOf | Korean Journal of Transplantation | - |
dc.title | Efficacy and safety of a switch from twice-daily tacrolimus to once-daily generic tacrolimus in stable liver transplant patients | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 2 | - |
dc.identifier.doi | 10.4285/kjt.21.0012 | - |
dc.identifier.bibliographicCitation | Korean Journal of Transplantation, v.35, no.3, pp.168 - 176 | - |
dc.identifier.kciid | ART002760449 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-85123016253 | - |
dc.citation.endPage | 176 | - |
dc.citation.startPage | 168 | - |
dc.citation.title | Korean Journal of Transplantation | - |
dc.citation.volume | 35 | - |
dc.citation.number | 3 | - |
dc.contributor.affiliatedAuthor | 최상태 | - |
dc.subject.keywordAuthor | Tacrolimus | - |
dc.subject.keywordAuthor | Liver transplantation | - |
dc.subject.keywordAuthor | Therapeutic equivalence | - |
dc.subject.keywordAuthor | Immunosuppression | - |
dc.description.journalRegisteredClass | kci | - |
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