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Efficacy and safety of prolonged-release versus immediate-release tacrolimus in de novo liver transplant recipients in South Korea: a randomized open-label phase 4 study (MAPLE)

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dc.contributor.author김순일-
dc.contributor.author이재근-
dc.contributor.author최진섭-
dc.date.accessioned2022-08-16T08:26:43Z-
dc.date.available2022-08-16T08:26:43Z-
dc.date.issued2019-06-
dc.identifier.issn2671-8790-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/188998-
dc.description.abstractBackground: Prolonged-release tacrolimus is associated with better long-term graft and patient survival than the immediate-release formulation in liver transplant patients. However, no clinical data are available to assess the efficacy and safety of early conversion from twice-daily, immediate-release tacrolimus to once-daily, prolonged-release tacrolimus in de novo liver transplant recipients in Korea. Methods: A 24-week, randomized, open-label study was conducted in 36 liver transplant recipients. All patients received immediate- release tacrolimus (0.1-0.2 mg/kg/day, divided into two doses) for 4 weeks after transplantation, at which time 50% of the patients were converted, at a ratio of 1 mg to 1 mg, to prolonged-release tacrolimus (once-daily). The primary efficacy endpoint was the incidence of biopsy-confirmed acute rejection (BCAR) from weeks 4 to 24 after transplantation (per-protocol set). Medication adherence, adverse event profiles, laboratory tests, vital signs, and physical changes were also recorded. Results: BCAR frequency at 24 weeks was similar between the two treatment groups; two cases (mean±standard deviation, 0.14±0.53 cases) of BCAR were reported in one patient treated with prolonged-release tacrolimus (n=14), while no such cases were reported among patients treated with immediate-release tacrolimus (n=12). The tacrolimus blood concentration at weeks 12 and 24, medication adherence, and adverse event profiles were also similar between the formulations, with no unusual laboratory test results, vital signs, or physical changes reported. Conclusions: Early conversion to a simplified, once-daily, prolonged-release tacrolimus regimen may be an effective treatment option for liver transplant recipients in Korea. Larger-scale studies are warranted to confirm non-inferiority to immediate-release tacrolimus formulation in de novo liver transplant recipients.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Society for Transplantation-
dc.relation.isPartOfKorean Journal of Transplantation-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleEfficacy and safety of prolonged-release versus immediate-release tacrolimus in de novo liver transplant recipients in South Korea: a randomized open-label phase 4 study (MAPLE)-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Surgery (외과학교실)-
dc.contributor.googleauthorMyoung Soo Kim-
dc.contributor.googleauthorJae-Won Joh-
dc.contributor.googleauthorDong-Sik Kim-
dc.contributor.googleauthorSeoung Hoon Kim-
dc.contributor.googleauthorJin Sub Choi-
dc.contributor.googleauthorJaegeun Lee-
dc.contributor.googleauthorJee Youn Lee-
dc.contributor.googleauthorJong Man Kim-
dc.contributor.googleauthorChoon Hyuck David Kwon-
dc.contributor.googleauthorGyu-Seong Choi-
dc.contributor.googleauthorYoung Dong Yu-
dc.contributor.googleauthorYong-In Yoon-
dc.contributor.googleauthorJae Hyun Han-
dc.contributor.googleauthorYun Jeong Lee-
dc.contributor.googleauthorHongsi Jiang-
dc.contributor.googleauthorSoon-Il Kim-
dc.identifier.doi10.4285/jkstn.2019.33.2.20-
dc.contributor.localIdA00649-
dc.contributor.localIdA03068-
dc.contributor.localIdA04199-
dc.relation.journalcodeJ04229-
dc.identifier.eissn2671-8804-
dc.identifier.pmid35769149-
dc.subject.keywordHumans-
dc.subject.keywordImmunosuppressive agents-
dc.subject.keywordLiver transplantation-
dc.subject.keywordProlonged-release tacrolimus-
dc.subject.keywordRepublic of Korea-
dc.subject.keywordTreatment outcome-
dc.contributor.alternativeNameKim, Soon Il-
dc.contributor.affiliatedAuthor김순일-
dc.contributor.affiliatedAuthor이재근-
dc.contributor.affiliatedAuthor최진섭-
dc.citation.volume33-
dc.citation.number2-
dc.citation.startPage20-
dc.citation.endPage29-
dc.identifier.bibliographicCitationKorean Journal of Transplantation, Vol.33(2) : 20-29, 2019-06-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers

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