Korean J Transplant.  2021 Oct;35(Supple 1):S117. 10.4285/ATW2021.OR-1202.

Safety and efficacy of early corticosteroid withdrawal in liver transplant recipients: new-onset diabetes after liver transplantation randomized clinical trial

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

• KMID: 2521359
• DOI: http://doi.org/10.4285/ATW2021.OR-1202

Abstract

Background
Standard practice for immunosuppressive therapy after liver transplantation (LT) is triple therapy, tacrolimus (TAC), mycophenolate mofetil, and corticosteroid triple therapy. Long-term steroid intake significantly increases cardiovascular risk factors with negative effects on patient outcome, especially post-transplantation diabetes associated with morbidity and mortality. In this trial, we examined the efficacy and safety parameters of early steroid withdrawal during the first year after LT.
Methods
In this open-label, multicenter, randomized controlled trial, we randomly assigned LT recipients in a 1:1 ratio to receive either early corticosteroid withdrawal at 2 weeks (group 1) or corticosteroid withdrawal at 3 months (group 2) after LT. The study was performed at four centers across Korea. Only participants between 20 and 70 years of age who were scheduled to receive a single-organ liver transplant from either a living donor or a deceased donor were considered for enrollment. The primary endpoint was the incidence of new-onset diabetes after liver transplantation (NODAT) at 12 months. All analyses were done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02095418.
Results
Between November 2012 to August 2020, 115 patients were randomly assigned to group 1 (n=60) or group 2 (n=55). The incidence of NODAT in group 1 (32.4%) was increased compared to group 2 (10.0%) in the per-protocol set. Additionally, biopsy-proven acute rejection (BPAR), graft failure, and death were not developed; however, median TAC trough level/dose/weight in group 1 were generally higher than in group 2. Safety parameters such as infection or the incidence of hepatocellular carcinoma recurrence did not differ between the two groups.
Conclusions
Early steroid withdrawal at 2 weeks after LT shows higher NODAT development compared with steroid withdrawal at post-transplant 3 months because of generally high TAC exposure. However, early steroid withdrawal can be achieved without loss of efficacy including BPAR, graft loss, and death.