Delayed Introduction of Everolimus in De Novo Renal Transplanted Patients: A Single-Center Experience.
BACKGROUND
Immunosuppressive protocols containing everolimus (EVR) preserve good renal function in kidney transplantation (KT), although they are often complicated by several adverse events. We have evaluated the efficacy and safety of a protocol with late (1 month after KT) EVR introduction.


METHODS
This study randomized 49 de novo patients undergoing KT between September 2012 and June 2014 into 2 groups: group A (n = 24) with late EVR introduction and tacrolimus reduction, and group B (control group; n = 25) with a standard immunosuppressive regimen. Primary aims were 1-year patient and graft survivals and acute rejection rates. Secondary aims were related to wound, metabolic, and hematologic complications.


RESULTS
Patient and graft survivals were similar in both groups. One year after KT, median serum creatinine was inferior in group A (1.4 vs 1.8 mg/dL; P = .004). Late acute rejection (8.3 vs 12.0%; P = 1.0) and wound complication (4.2 vs 4.0%; P = 1.0) rates were similar. Higher cholesterol and triglycerides and lower platelets and hemoglobin levels were observed in group A.


CONCLUSIONS
In our experience, delayed introduction of EVR shows similar results with respect to its early introduction, contemporaneously presenting fewer wound complications and lymphoceles. A higher rate of metabolic and hematologic complications are, however, observed in patients under EVR therapy. Further multicenter studies should be performed to confirm these preliminary results.
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy. Electronic address: renzopretagostini@hotmail.it.
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Pretagostini
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Poli
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Pettorini
Department of General Surgery and Transplantation, San Salvatore Hospital, L'Aquila University, L'Aquila, Italy.
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Lai
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Garofalo
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Melandro
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Nudo
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Rossi
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Casciaro
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Della Pietra
Department of General Surgery and Transplantation "P. Stefanini", Sapienza University of Rome, Italy.
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Berloco
D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000097:blood*; D016559:Tacrolimus / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D000068338:Everolimus; D016559:Tacrolimus