title: Tacrolimus versus cyclosporine for early steroid withdrawal after renal transplantation.
abstract: BACKGROUND
  This study compares cyclosporine (CsA) with tacrolimus (Tac) in preventing acute rejection (AR) after steroid withdrawal (SW) 5 days after renal transplantation (Tx).
  
  
  METHODS
  The data were collected from 2 prospective sequential studies carried out from February 2002 to May 2006. Forty-nine patients received CsA, 56 patients Tac. Rapamycin (Rapa) was added to both calcineurin inhibitors (CNIs). The studies were homogeneous regarding both clinical procedures and patient demographics.
  
  
  RESULTS
  Three years after SW, Tac was more effective than CsA in reducing the risk both of AR (35% vs. 53%; p<0.06) and mainly of relapses (9% vs. 33%; p<0.007). In addition, Tac enabled more patients to go onto a steroid-free regime (88% vs. 65%; p<0.01). No difference arose concerning the timing of AR, graft function, CNI withdrawal, incidence of side effects or patient and graft survival rates. In both groups, rejection after SW was associated with a worse graft function.
  
  
  CONCLUSIONS
  Tac was more effective than CsA in preventing AR after early SW, and increased significantly patient probability of maintaining a steroid-free regime. In this setting, Tac and CsA had the same safety profile. However, a follow-up longer than 3 years might be needed to estimate the consequences of the higher rate of AR encountered under CsA therapy.
authors.affiliation: Division and Chair of Nephrology, University Hospital Spedali Civili, Brescia, Italy. sandrini.silvio@libero.it
authors.forename: Silvio
authors.initials: S
authors.lastname: Sandrini
authors.forename: Naveed
authors.initials: N
authors.lastname: Aslam
authors.forename: Regina
authors.initials: R
authors.lastname: Tardanico
authors.forename: Gisella
authors.initials: G
authors.lastname: Setti
authors.forename: Nicola
authors.initials: N
authors.lastname: Bossini
authors.forename: Francesca
authors.initials: F
authors.lastname: Valerio
authors.forename: Monica
authors.initials: M
authors.lastname: Insalaco
authors.forename: Roberto
authors.initials: R
authors.lastname: Maffeis
authors.forename: Franco
authors.initials: F
authors.lastname: Nodari
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cancarini
mesh_terms: D000208:Acute Disease; D000328:Adult; D016009:Chi-Square Distribution; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D020123:Sirolimus / Q000627:therapeutic use; D013256:Steroids / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D028761:Withholding Treatment
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D020123:Sirolimus; D016559:Tacrolimus