title: Tacrolimus plus mycophenolate mofetil vs. cyclosporine plus everolimus in deceased donor kidney transplant recipients: three-yr results of a single-center prospective clinical trial.
abstract: We compared in kidney transplantation two immunosuppressive regimens: tacrolimus plus mycophenolate mofetil (MMF) (TAC) and everolimus plus low-dose cyclosporine (EVE). Sixty consecutive patients received TAC (30 patients) or EVE (30 patients) as immunosuppressive regimen; all subjects also received induction with basiliximab and corticosteroids. After three-yr follow-up, no difference was found in patient and graft survival (PTS: TAC: 97% vs. EVE: 100%; GS: TAC: 93% vs. EVE: 93%). The incidence of acute rejection was higher in the EVE group but the difference was not statistically significant (17% vs. 23%, p = ns). Patients in EVE showed higher serum cholesterol (205 ± 41 vs. 235 ± 41 mg/dL, p = 0.0012) and lower hemoglobin concentration (13.6 ± 1.4 vs. 12.4 ± 1.9, p = 0.01). Renal function was not significantly different in the two groups (3 Y creatinine: TAC 1.4 ± 0.8 vs. EVE 1.6 ± 0.8 mg/dL, p = ns). Treatment discontinuation was higher in the EVE group (TAC 17 vs. EVE 36%, p = ns). Our data show that in the middle-term follow-up, an immunosuppressive regimen with tacrolimus plus MMF has a similar efficacy and safety profile in comparison with the combination of low-exposure cyclosporine plus everolimus. Further follow up could evidence the benefits related to the anti-proliferative effects of everolimus.
authors.affiliation: Department of Surgery, Renal Transplantation Unit, Catholic University, Rome, Italy.
authors.forename: Evaldo
authors.initials: E
authors.lastname: Favi
authors.forename: Gionata
authors.initials: G
authors.lastname: Spagnoletti
authors.forename: Maria P
authors.initials: MP
authors.lastname: Salerno
authors.forename: José A
authors.initials: JA
authors.lastname: Pedroso
authors.forename: Jacopo
authors.initials: J
authors.lastname: Romagnoli
authors.forename: Franco
authors.initials: F
authors.lastname: Citterio
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D016572:Cyclosporine / Q000627:therapeutic use; D051799:Delayed Graft Function; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000601:surgery; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus
keywords: acute rejection; cyclosporine; everolimus; immunosuppression; kidney transplantation; tacrolimus