Abstract

BACKGROUND: The efficacy in renal protection of Everolimus (Evr)-based regimens compared to standard dosages of Tacrolimus (Tac) has recently become known. The purpose of this study was to retrospectively compare the renal function in the first year after LT, with a case-control approach, in patients treated with Tac monotherapy at sub-standard dose vs. an immunosuppressive regimen with Tac and Evr.

MATERIAL AND METHODS: Following a 2: 1 case-control approach, 37 patients with an immunosuppression regimen based on Tac only (Tac Group) were retrospectively compared with 74 patients utilizing a combination of Evr and Tac (Evr-Tac Group), based on the following preoperative parameters: sex, age, MELD score (±3), and pre-LT chronic kidney disease (CKD) stage.

RESULTS: After a mean follow-up of 82.8±24 vs. 42.4±16.6 months (p<0.001), overall survival in 1, 3, and 5 years was 97.3, 91.9, and 86.5% vs. 95.9, 81.1, and 69.5% (p=0.10) for the Tac Group vs. the Evr-Tac Group, respectively. The trend of the estimated glomerular filtration rate (e-GFR) during the first year post-LT was similar between the 2 study groups (80.1±21 vs. 73.3±16 mL/min/1.73 m^2, for the Tac Group vs. the Evr-Tac Group, respectively, p=0.23). The incidence of acute rejection histologically proven was 32.4% vs. 20% (p=0.71) for the Tac Group vs. the Tac-Evr Group, respectively. The rate of CKD was also similar in the 2 study groups.

CONCLUSIONS: The early combination of Evr and Tac is an efficient immunosuppressant regimen and provided similar renal function at 1 year post-LT, compared to a minimization of the monotherapy dose of Tac. The combination therapy of Evr-Tac is subject to a higher rate of drugs discontinuation due to adverse effects of 1 of the 2 drugs.

Keywords: Liver Transplantation, renal insufficiency, Tacrolimus