Ann Hepatobiliary Pancreat Surg.  2024 May;28(2):238-247. 10.14701/ahbps.23-129.

Safety and efficacy of early corticosteroid withdrawal in liver transplant recipients: A randomized controlled trial

• Kim J
• Joh JW
• Lee KW
• Choi DL
• Wang HJ

• KMID: 2555934
• DOI: http://doi.org/10.14701/ahbps.23-129

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Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation.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.

Keyword

Tacrolimus; Treatment outcome; Immunosuppression; Diabetes mellitus; Safety

Figure

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  Fig. 1 Patient distribution and study population.

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  Fig. 2 Median tacrolimus trough level/dose/WT at each visit. Group 1, steroid withdrawal at 2 weeks after transplantation; Group 2, steroid withdrawal at 3 months after transplantation. WT, weight. *p < 0.05.

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  Fig. 3 New-onset diabetes after transplantation development after liver transplantation. (A) Full-analysis set. (B) Per-protocol set. Group 1, steroid withdrawal at 2 weeks after transplantation; Group 2, steroid withdrawal at 3 months after transplantation.

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  Fig. 4 Adverse events. Group 1, steroid withdrawal at 2 weeks after transplantation; Group 2, steroid withdrawal at 3 months after transplantation.

Reference

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