title: Once-a-day administration of everolimus is safe in de novo renal transplant recipients: 1-year results of a pilot study.
abstract: BACKGROUND
  The half-life of everolimus is approximately 28 hours, but everolimus is generally administered twice a day. The aim of this prospective, single-center, exploratory study was to compare the efficacy and safety of a once a day everolimus (OD) with the standard twice a day administration regimen (BID) as immunosuppressive therapy in renal transplantation.
  
  
  METHODS
  Forty-one de novo renal transplant recipients prospectively assigned to OD (n=21) or BID (n=20) treatment were followed for 1 year. In the OD group, everolimus was orally administered targeting a trough blood level of 2 to 5 ng/mL. In the BID group, everolimus was given twice a day targeting a trough blood level of 3 to 12 ng/mL. All patients also received induction with basiliximab and low-dose calcineurin inhibitor immunosuppression.
  
  
  RESULTS
  At 1 year follow-up patient and graft survivals were 100%. The intention-to-treat analysis showed similar renal function between the two regimens: serum creatinine values for OD 1.54 ± 0.6 versus BID 1.48 ± 0.53 mg/dL (P=NS). Also the occurrence of acute rejection episodes was not significantly different: 4.8% in the OD versus 15% in the BID group, (P=NS). The median trough blood levels were significantly lower among the OD group: OD 4.5 versus BID 7.2 ng/mL (P<.001).
  
  
  CONCLUSIONS
  This study demonstrated that once a day administration of everolimus achieved excellent patient and graft survival and good renal function without an increased incidence of acute rejection episodes.
authors.affiliation: Department of Surgical Science, Renal Transplant Unit, Catholic University, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Spagnoletti
authors.forename: E
authors.initials: E
authors.lastname: Favi
authors.forename: A
authors.initials: A
authors.lastname: Gargiulo
authors.forename: M P
authors.initials: MP
authors.lastname: Salerno
authors.forename: F
authors.initials: F
authors.lastname: Citterio
mesh_terms: D000284:Administration, Oral; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000077552:Basiliximab; D065095:Calcineurin Inhibitors; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007558:Italy; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D000068338:Everolimus; D020123:Sirolimus