title: Immunosuppressive drugs after simultaneous pancreas-kidney transplantation.
abstract: BACKGROUND
  We report the early and late secondary effects of tacrolimus or cyclosporine-microemulsion (ME), in combination with mycophenolate mofetil (MMF), and rATG.
  
  
  METHODS
  One hundred three patients were randomly assigned to tacrolimus (initial oral dose 0.2 mg/kg) and 102 to cyclosporine-ME (initial daily oral dose 7 mg/kg). All patients received 4 days of concomitant rATG induction therapy [ATG-Fresenius Biotech GmbH (ATG-F) daily dose of 4 mg/kg or Thymoglobulin-Genzyme/Sangstat (Thymo-S) 1.25 mg/kg], MMF (2 to 3 g per day), and short-term corticosteroids.
  
  
  RESULTS
  Thymo-S was associated with a transiently lower white cell count in the first 3 months compared with ATG-F, while ATG-F caused a lower albeit transient early nadir in platelet count. Both polyclonal preparations were well tolerated; they did not differ with respect to clinically relevant side effects such as infections and malignancies. Higher cyclosporine-ME trough levels were associated with pancreas graft thrombosis. Study withdrawal was more frequent among patients on cyclosporine-ME therapy, because of toxicities, graft loss, and lack of efficacy, the last being the cause of subsequent switch to tacrolimus. Tacrolimus-treated patients were mainly withdrawn from the study due to MMF discontinuation.
  
  
  CONCLUSIONS
  Short-term induction therapy in combined kidney-pancreas transplantation is effective and well tolerated. Tacrolimus causes fewer pancreas graft losses and fewer drug discontinuations due to side effects. When MMF is combined with tacrolimus, dose reductions and discontinuations are common.
authors.affiliation: EUROSPK Central Office, Brussels, Belgium. jacques.malaise@chir.ucl.ac.be
authors.forename: J
authors.initials: J
authors.lastname: Malaise
authors.forename: D R J
authors.initials: DR
authors.lastname: Kuypers
authors.forename: K
authors.initials: K
authors.lastname: Claes
authors.forename: P
authors.initials: P
authors.lastname: Evenepoel
authors.forename: B
authors.initials: B
authors.lastname: Maes
authors.forename: W
authors.initials: W
authors.lastname: Coosemans
authors.forename: J
authors.initials: J
authors.lastname: Pirenne
authors.forename: Y
authors.initials: Y
authors.lastname: Vanrenterghem
authors.forename: D
authors.initials: D
authors.lastname: Van Ophem
authors.forename: J P
authors.initials: JP
authors.lastname: Squifflet
mesh_terms: D000961:Antilymphocyte Serum / Q000627:therapeutic use; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004655:Emulsions; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D007958:Leukocyte Count; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D016035:Pancreas Transplantation / Q000276:immunology* / Q000401:mortality; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000961:Antilymphocyte Serum; D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D016559:Tacrolimus