Everolimus versus Mycophenolate Mofetil in Combination with Tacrolimus: A Propensity Score Matching Analysis in Liver Transplantation.
1Hepatobiliary Surgery and Liver Transplantation, University of Pisa Medical School Hospitals, Pisa, Italy
2Laboratory, University of Pisa Medical School Hospital, Pisa, Italy.
Meeting: 2016 American Transplant Congress
Abstract number: 145
Keywords: Adverse effects, Immunosuppression, Liver transplantation, Outcome
Session Information
Session Name: Concurrent Session: Liver: Immunosuppression and Rejection
Session Type: Concurrent Session
Date: Sunday, June 12, 2016
Session Time: 4:30pm-6:00pm
Presentation Time: 5:42pm-5:54pm
Location: Room 312
Background: No trial has so far investigated everolimus (EVR)-incorporating immunosuppressive regimens versus combined use of tacrolimus (TAC) and mycophenolate mofetil (MMF) in liver transplantation (LT).
Materials and methods: This was a retrospective analysis of adult, LT recipients at a single center. A total of 302 adult, LT recipients (mean [SD] age 51.2 [6.4] years; male 76.5%; mean [SD] time since transplantation 49.7 [11.6] months) who received EVR in their post-transplant course were matched to recipients on TAC+MMF with a propensity score approach per strata and using age, indication to transplantation, de novo versus maintenance use, time since transplantation, and renal function (≥40mL/min/1.73m2) as confounders. A final set of 178 patients on EVR+TAC was compared with 178 patients on TAC+MMF.
Results: At a median ⦥ follow-up of 48.5 [0-112] months graft loss was similar in the two groups (4.5% [8/178] for EVR versus 5.6% [10/178] for MMF, p=0.62). Incidence of treated and biopsy proven acute rejection was numerically lower in the EVR group (3.3% [6/178] versus 7.3% [13/178]; OR 0.44, p=0.09), while incidence of AEs (70.2% [125/178] versus 58.9% [105/178]; OR 1.6, p=0.02) and drug discontinuation (21.3% [38/178] versus 11.8% [21/178], OR 1.8, p=0.01) were statistically higher in the EVR group, with regard to hypercholesterolemia (OR 2.5, p=0.001), and edema (OR 4.9, p=0.006). Patients on EVR showed lesser deterioration in baseline renal function at the latest follow-up visit versus those on MMF (-2.2 [1.8] versus -5.1 [3.2] mL/min, t=3.6, p=0.005).
Conclusions: Despite the limitations of a retrospective analysis, our results show that an immunosuppressive regimen incorporating EVR and TAC provides similar efficacy results versus TAC+MMF. Incidence of drug discontinuations and AEs were higher in the EVR group, with regard to hypercholesterolemia and edema. However, patients on EVR showed lower renal function deterioration as a result of reduced exposure to TAC. A prospective trial is highly favored to address all of these issues.
CITATION INFORMATION: de Simone P, Carrai P, Precisi A, Coletti L, Ghinolfi D, Filipponi F. Everolimus versus Mycophenolate Mofetil in Combination with Tacrolimus: A Propensity Score Matching Analysis in Liver Transplantation. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
Simone Pde, Carrai P, Precisi A, Coletti L, Ghinolfi D, Filipponi F. Everolimus versus Mycophenolate Mofetil in Combination with Tacrolimus: A Propensity Score Matching Analysis in Liver Transplantation. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-versus-mycophenolate-mofetil-in-combination-with-tacrolimus-a-propensity-score-matching-analysis-in-liver-transplantation/. Accessed May 11, 2025.« Back to 2016 American Transplant Congress