title: A prospective, randomized clinical trial of cyclosporine reduction in stable patients greater than 12 months after renal transplantation.
abstract: BACKGROUND
  For stable kidney-transplant recipients receiving triple drug therapy with cyclosporine (CsA), prednisone, and mycophenolate mofetil (MMF), it remains unclear what is the optimal dose of CsA beyond the first 6 to 12 months after transplantation. Complete CsA withdrawal has been associated with a significant incidence of acute rejection and, in some studies, chronic rejection as well.
  
  
  METHODS
  We performed an open, prospectively randomized, controlled clinical trial to determine whether CsA could be safely reduced by 50%. At 1 year or more posttransplant, 64 patients were randomized to either continue their stable-maintenance CsA dose (control group, n=32) or to lower their CsA dose by 50% over a 2 month period (CsA reduction group, n=32). All patients had stable renal-allograft function at the time of enrollment.
  
  
  RESULTS
  Within 6 months of randomization, no episode of acute rejection or graft loss occurred in either group. Patients in the CsA reduction group had a slight but significant increase in their glomerular filtration rate and a trend towards lower serum creatinine. There was also a significant decrease in mean systolic blood pressure, triglycerides, and serum uric acid levels in the CsA reduction group. No significant changes in any of these parameters were observed in the control group.
  
  
  CONCLUSIONS
  This study suggests that a strategy consisting of a 50% CsA reduction is safe and is not associated with the increased risk of acute rejection observed in CsA withdrawal studies. It also has the potential to improve short-term allograft function and appears to reduce cardiovascular risk factors such as hypertension and hyperlipidemia.
authors.affiliation: Renal and Transplantation Units, Massachusetts General Hospital, Boston, USA. Arslan@chuv.hospud.ch
authors.forename: Manuel
authors.initials: M
authors.lastname: Pascual
authors.forename: John
authors.initials: J
authors.lastname: Curtis
authors.forename: Francis L
authors.initials: FL
authors.lastname: Delmonico
authors.forename: Mary Lin
authors.initials: ML
authors.lastname: Farrell
authors.forename: Winfred W
authors.initials: WW
authors.lastname: Williams
authors.forename: Roberto
authors.initials: R
authors.lastname: Kalil
authors.forename: Patsy
authors.initials: P
authors.lastname: Jones
authors.forename: A Benedict
authors.initials: AB
authors.lastname: Cosimi
authors.forename: Nina
authors.initials: N
authors.lastname: Tolkoff-Rubin
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage*; D005260:Female; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D011446:Prospective Studies; D013997:Time Factors; D014184:Transplantation, Homologous
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid