Abstract
Tacrolimus (TAC), a calcineurin inhibitor, and everolimus (EVL), an mTOR inhibitor, have been used as immunosuppressive (ISS) drugs in post-kidney transplantation therapy. The objective of this study was to compare the efficacy of EVL vs TAC in the ISS maintenance triple therapy. Ninety-seven kidney transplant patients, who received triple maintenance therapy with TAC, mycophenolate mofetil (MMF), and methyl prednisone (PRED), were evaluated. After four months of post-kidney transplant therapy, 30 patients enrolled in a randomized controlled clinical trial, in which 16 patients received TAC+MMF+PRED (cohort 1), and 14 patients switched to EVL+MMF+PRED (cohort 2). The patients were followed-up for 36 months. Two patients from cohort 1 lost their grafts after one year due to non-adherence. Two patients from cohort 2 had intolerance to mTOR inhibitors and were switched back to TAC from EVL. One case (6.25%) in cohort 1 and three cases (21.43%) in cohort 2 of acute T-cell-mediated rejection was observed. Antibody-mediated acute rejection (ABMAR) was observed in four patients (25.0%) in cohort 1, and antibody-mediated chronic rejection (ABMCR) was observed in two patients (12.50%). One patient from cohort 2 lost the graft after 15 months due to polyomavirus infection. The graft survival rate was 87.50% in cohort 1 and 92.86% in cohort 2. This clinical trial showed that the EVL+MMF+PRED triple maintenance therapy was efficacious compared with TAC during 32 months of follow-up. However, further studies are needed to confirm the efficacy of this regimen for long-term graft survival.
Highlights
Tacrolimus (TAC), a calcineurin inhibitor (CNI), is an immunosuppressive drug associated with a substantial risk of nephrotoxicity
The premature discontinuation of a CNI therapy within 3 months rather than the protocol-recommended 6 months can prevent an increase in creatinine clearance that requires switching to an mTOR inhibitor in the short period for maintenance therapy to improve allograft function [8,9,10,11]
Prospective and randomized clinical trials have indicated that the combination of an mTOR inhibitor with mycophenolate mofetil (MMF) is not sufficiently effective in preventing acute rejection during
Summary
Tacrolimus (TAC), a calcineurin inhibitor (CNI), is an immunosuppressive drug associated with a substantial risk of nephrotoxicity. After kidney transplantation (KT), TAC is administered to inhibit cytokine (IL-2, IL-5, and IFN-g) production and downregulate T cell activation. It is one of the most effective and widely used immunosuppressive drugs to prevent rejection and increase graft survival [1,2]. Despite its effectiveness, it can cause acute and chronic nephrotoxicity following allograft dysfunction [3]. The premature discontinuation of a CNI therapy within 3 months rather than the protocol-recommended 6 months can prevent an increase in creatinine clearance that requires switching to an mTOR inhibitor in the short period for maintenance therapy to improve allograft function [8,9,10,11]
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