title: Tacrolimus and Everolimus de novo versus minimization of standard dosage of Tacrolimus provides a similar renal function at one year after liver transplantation: a case-control matched-pairs analysis.
abstract: BACKGROUND
  The efficacy in renal protection of Everolimus (Evr)-based regimens compared to standard dosages of Tacrolimus (Tac) has recently become known. The purpose of this study was to retrospectively compare the renal function in the first year after LT, with a case-control approach, in patients treated with Tac monotherapy at sub-standard dose vs. an immunosuppressive regimen with Tac and Evr.
  
  
  METHODS
  Following a 2: 1 case-control approach, 37 patients with an immunosuppression regimen based on Tac only (Tac Group) were retrospectively compared with 74 patients utilizing a combination of Evr and Tac (Evr-Tac Group), based on the following preoperative parameters: sex, age, MELD score (±3), and pre-LT chronic kidney disease (CKD) stage.
  
  
  RESULTS
  After a mean follow-up of 82.8 ± 24 vs. 42.4 ± 16.6 months (p < 0.001), overall survival in 1, 3, and 5 years was 97.3, 91.9, and 86.5% vs. 95.9, 81.1, and 69.5% (p = 0.10) for the Tac Group vs. the Evr-Tac Group, respectively. The trend of the estimated glomerular filtration rate (e-GFR) during the first year post-LT was similar between the 2 study groups (80.1 ± 21 vs. 73.3 ± 16 mL/min/1.73 m^2, for the Tac Group vs. the Evr-Tac Group, respectively, p = 0.23). The incidence of acute rejection histologically proven was 32.4% vs. 20% (p = 0.71) for the Tac Group vs. the Tac-Evr Group, respectively. The rate of CKD was also similar in the 2 study groups.
  
  
  CONCLUSIONS
  The early combination of Evr and Tac is an efficient immunosuppressant regimen and provided similar renal function at 1 year post-LT, compared to a minimization of the monotherapy dose of Tac. The combination therapy of Evr-Tac is subject to a higher rate of drugs discontinuation due to adverse effects of 1 of the 2 drugs.
authors.affiliation: Clinic of Hepatobiliary and Abdominal Transplantation Surgery, Department of Sperimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Mocchegiani
authors.affiliation: Clinic of Hepatobiliary and Abdominal Transplantation Surgery, Department of Sperimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Montalti
authors.affiliation: Clinic of Hepatobiliary and Abdominal Transplantation Surgery, Department of Sperimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Nicolini
authors.affiliation: Clinic of Gastroenterology, Department of Clinical and Molecular Science, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Svegliati Baroni
authors.affiliation: Clinic of Gastroenterology, Department of Clinical and Molecular Science, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Benedetti
authors.affiliation: Clinic of Surgery, Department of Medical and Biological Science, University of Udine, Udine, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Risaliti
authors.affiliation: Clinic of Hepatobiliary and Abdominal Transplantation Surgery, Department of Sperimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Vivarelli
mesh_terms: D000328:Adult; D000368:Aged; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D007677:Kidney Function Tests; D016031:Liver Transplantation; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000139:chemically induced*; D012189:Retrospective Studies; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016559:Tacrolimus / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus; D016559:Tacrolimus