Annals of Hepato-Biliary-Pancreatic Surgery (한국간담췌외과학회지)

The Korean Association of Hepato-Biliary-Pancreatic Surgery (한국간담췌외과학회)
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Safety and efficacy of early corticosteroid withdrawal in liver transplant recipients: A randomized controlled trial

  • Jongman Kim (Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Jae-Won Joh (Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kwang-Woong Lee (Department of Surgery, Seoul National University College of Medicine) ;
  • Dong Lak Choi (Department of Surgery, Catholic University of Daegu College of Medicine) ;
  • Hee-Jung Wang (Department of Liver Transplantation and Hepatobiliary Surgery, Ajou University School of Medicine)
  • Received : 2023.10.24
  • Accepted : 2024.02.04
  • Published : 2024.05.31
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Abstract

Backgrounds/Aims: Prolonged use of steroids after liver transplantation (LT) significantly increases the risk of diabetes or cardiovascular disease, which can adversely affect patient outcomes. Our study evaluated the effectiveness and safety of early steroid withdrawal within the first year following LT. Methods: This study was conducted as an open-label, multicenter, randomized controlled trial. Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation. This study included participants aged 20 to 70 years who were scheduled to undergo a single-organ liver transplant from a living or deceased donor at one of the four participating centers. Results: Between November 2012 and August 2020, 115 patients were selected and randomized into two groups, with 60 in Group 1 and 55 in Group 2. The incidence of new-onset diabetes after transplantation (NODAT) was notably higher in Group 1 (32.4%) than in Group 2 (10.0%) in the per-protocol set. Although biopsy-proven acute rejection, graft failure, and mortality did not occur, the median tacrolimus trough level/dose/weight in Group 1 exceeded that in Group 2. No significant differences in safety parameters, such as infection and recurrence of hepatocellular carcinoma, were observed between the two groups. Conclusions: The present study did not find a significant reduction in the incidence of NODAT in the early steroid withdrawal group. Our study suggests that steroid withdrawal three months posttransplantation is a standard and safe immunosuppressive strategy for LT patients.

Keywords

Acknowledgement

This research was supported by the Basic Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT (NRF2023R1A2C2005946).

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