Long-term Efficacy and Safety of Everolimus Versus Mycophenolate in Kidney Transplant Recipients Receiving Tacrolimus.Nunes Ficher, K., et al.
Transplantation 2022; 106(2): 381-390.
This post hoc analysis aimed to report the 5-year follow-up outcomes of a randomised controlled trial investigating the efficacy and safety of everolimus compared to mycophenolate in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen.
Participants in the original trial were randomised to one of three groups: rabbit antithymocyte globulin ( r-ATG) plus everolimus, basiliximab plus everolimus, or basiliximab plus mycophenolate.
300 de novo kidney transplant recipients.
The main outcomes included assessment of treatment failure, treated clinical acute rejection episodes, serum HLA antibodies, estimated glomerular filtration rate (eGFR), proteinuria, blood pressure, body mass index (BMI), high-density lipoprotein cholesterol (HDL)/ low-density lipoprotein cholesterol (LDL), posttransplant diabetes mellitus (PTDM), use of lipidlowering agents, major adverse cardiovascular events (MACEs), and malignancies.
This paper reports the 5-year outcomes from a previously published trial comparing 3 different immune suppression regimens. The number lost to follow up was small and similar between the study arms. The primary outcome was a composite “treatment failure” defined as biopsy proven rejection >1A, graft loss, death or loss to follow up. There was no significant difference in the rate of this primary outcome. There was no significant difference GFR. There was however a higher risk of post-transplant diabetes with the groups receiving everolimus (30-33% versus 15%). In this group of low/moderate risk renal transplant recipients, all three immune suppression regimens were associated with acceptable outcomes. Similar proportions of each group were still receiving their randomised therapy at 5 years.
ClinicalTrials.gov - NCT01354301