title: A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report.
abstract: This report summarizes year 1 blinded data from a 5-year prospective, randomized (1:1, stratified by race and donor type), multicenter, double-blind study comparing treatment failure rates between early cessation of corticosteroid therapy and long-term corticosteroid maintenance therapy in 397 primary renal transplant recipients receiving tacrolimus and mycophenolate mofetil with antibody induction. Sixteen (4.1%) patients died or experienced graft loss during year 1 (9 deaths, 6 graft losses, and 1 death with a graft loss). Fifty-nine (15.3%) patients experienced rejection; 40 (10.4%) of these cases were biopsy-confirmed. Values for 10-year predictive risk of coronary heart disease (CHD) estimated from the Framingham Heart Study scores showed a shift from baseline toward a more favorable risk profile. Renal transplant recipients treated with a tacrolimus-based immunosuppressive regimen and either early cessation or maintenance of corticosteroid therapy experienced excellent patient and graft survival, low acute rejection rates, low rate of posttransplantation diabetes mellitus (9.0%), and improved CHD risk profile at 1 year posttransplantation.
authors.affiliation: Division of Transplantation, University of Cincinnati, Cincinnati, Ohio 45249, USA. woodlees@uc.edu
authors.forename: E S
authors.initials: ES
authors.lastname: Woodle
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects*; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D001706:Biopsy; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000401:mortality; D006801:Humans; D007430:Intraoperative Care; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011446:Prospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use; D013997:Time Factors; D017211:Treatment Failure
chemical_list: D000305:Adrenal Cortex Hormones; D000961:Antilymphocyte Serum; D003404:Creatinine; D009173:Mycophenolic Acid; D016559:Tacrolimus