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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)

 Myoung Soo Kim  ;  Jae-Won Joh  ;  Dong-Sik Kim  ;  Seoung Hoon Kim  ;  Jin Sub Choi  ;  Jaegeun Lee  ;  Jee Youn Lee  ;  Jong Man Kim  ;  Choon Hyuck David Kwon  ;  Gyu-Seong Choi  ;  Young Dong Yu  ;  Yong-In Yoon  ;  Jae Hyun Han  ;  Yun Jeong Lee  ;  Hongsi Jiang  ;  Soon-Il Kim 
 Korean Journal of Transplantation, Vol.33(2) : 20-29, 2019-06 
Journal Title
Korean Journal of Transplantation
Issue Date
Humans ; Immunosuppressive agents ; Liver transplantation ; Prolonged-release tacrolimus ; Republic of Korea ; Treatment outcome
Background: 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.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Soon Il(김순일) ORCID logo https://orcid.org/0000-0002-0783-7538
Lee, Jae Geun(이재근) ORCID logo https://orcid.org/0000-0002-6722-0257
Choi, Jin Sub(최진섭)
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