title: Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up.
abstract: The aim of this study was to compare the long-term safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) plus mycophenolate mofetil (MMF) or tacrolimus (TAC) plus MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients. One hundred and thirty-one patients were randomized to receive either CsA (n = 63) or TAC (n = 68). Of these, 117 patients satisfied the criteria for steroid withdrawal (no biopsy-proven rejection episode and serum creatinine level <2.0 mg/dl 6 months after transplantation). Fifty-five recipients were of the CsA group, and 62 were of the TAC group. The 5-year graft survival rate did not differ between groups (90.5% vs. 93.3% respectively; P = 0.55). The cumulative incidence of acute rejection 5 years after transplantation was 16.4% and 8.1% for the CsA and TAC groups respectively (P = 0.15). Post-transplantation diabetes mellitus was more frequent in the TAC group than in the CsA group (P = 0.05), but the incidence of other side-effects did not differ between groups. In conclusion, CsA- and TAC-based regimens in conjunction with MMF have similar patient- and graft survival rates in low-risk patients who underwent steroid withdrawal 6 months after kidney transplantation.
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yu-Ji
authors.initials: YJ
authors.lastname: Lee
authors.forename: Beom
authors.initials: B
authors.lastname: Kim
authors.forename: Jung Eun
authors.initials: JE
authors.lastname: Lee
authors.forename: Yoon-Goo
authors.initials: YG
authors.lastname: Kim
authors.forename: Dae Joong
authors.initials: DJ
authors.lastname: Kim
authors.forename: Sung-Joo
authors.initials: SJ
authors.lastname: Kim
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Joh
authors.forename: Ha Young
authors.initials: HY
authors.lastname: Oh
authors.forename: Wooseong
authors.initials: W
authors.lastname: Huh
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000009:adverse effects / Q000502:physiology; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D011446:Prospective Studies; D013256:Steroids / Q000008:administration & dosage / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D009173:Mycophenolic Acid; D016559:Tacrolimus