title: Everolimus plus mycophenolate mofetil as initial immunosuppression in liver transplantation.
abstract: BACKGROUND
  The purpose of this study was to assess the efficacy and safety of a de novo immunosuppressive regimen with everolimus (EVL) plus mycophenolate mofetil (MMF) without calcineurin inhibitors (CNI) for liver transplantation. The secondary purpose was to compare the renal function with a control group of patients treated with tacrolimus plus MMF.
  
  
  METHODS
  Sixteen male and 4 female liver transplant patients received immunosuppression with EVL plus MMF without CNI, with induction with steroids and 16 with basiliximab also. In 10 cases it was indicated as induction immunosuppression without CNI as prevention against nephrotoxicity and neurotoxicity or recurrence of hepatocarcinoma in predisposed patients and in another 10 after withdrawing CNI during the immediate post-transplant period, before hospital discharge, as the result of toxicity, mainly nephrotoxicity and neurotoxicity or the presence of hepatocarcinoma with a high risk of recurrence. A control group comprising 31 patients taking tacrolimus plus MMF was included to compare the renal function.
  
  
  RESULTS
  The mean follow-up time was 24 months. One patient had a recurrence of hepatocarcinoma at 8 months after transplant. The cases of nephrotoxicity and neurotoxicity resolved favorably. There were 7 rejections (35%); 2 evolved to chronic rejection with both needing retransplantation, 2 resolved with dose adjustment, and 3 required conversion to CNI. The side effects were hyperlipidemia (25%), wound dehiscence (10%), lymphedema (10%), cytomegalovirus infection (25%), myelotoxicity (25%) and proteinuria >1 g in 1 case (5%). No differences were found in renal function between the two groups.
  
  
  CONCLUSIONS
  This regimen was proven to be efficient to prevent and treat nephrotoxicity and neurotoxicity with an acceptable tolerability profile. However, the high associated rejection rate indicates that great caution is required in its use during the immediate post-transplant period. It is advisable to associate the regimen with low doses of CNI and to have agile methods available to monitor EVL to enable rapid dose adjustment.
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain. Electronic address: mjimenezp@commalaga.com.
authors: M
authors: M
authors: Jiménez-Pérez
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.
authors: R
authors: R
authors: González Grande
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.
authors: F J
authors: FJ
authors: Rando Muñoz
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.
authors: J
authors: J
authors: de la Cruz Lombardo
authors: Unidad de Cirugía HB y Trasplante Hepático, UGC de Cirugía Digestiva, Hospital Regional Universitario de Málaga, Spain.
authors: M A
authors: MA
authors: Muñoz Suárez
authors: Unidad de Cirugía HB y Trasplante Hepático, UGC de Cirugía Digestiva, Hospital Regional Universitario de Málaga, Spain.
authors: J L
authors: JL
authors: Fernández Aguilar
authors: Unidad de Cirugía HB y Trasplante Hepático, UGC de Cirugía Digestiva, Hospital Regional Universitario de Málaga, Spain.
authors: J A
authors: JA
authors: Pérez Daga
authors: Unidad de Cirugía HB y Trasplante Hepático, UGC de Cirugía Digestiva, Hospital Regional Universitario de Málaga, Spain.
authors: J
authors: J
authors: Santoyo-Santoyo
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.
authors: R
authors: R
authors: Manteca González
authors: Unidad de Hepatología-Trasplante Hepático, UGC de Aparato Digestivo, Hospital Regional Universitario de Málaga, Spain.
authors: J M
authors: JM
authors: Rodrigo López
mesh_terms: D000328:Adult; D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000601:surgery*; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000601:surgery*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus