Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up.
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.
Lee
Yu-Ji
YJ
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kim
Beom
B
Lee
Jung Eun
JE
Kim
Yoon-Goo
YG
Kim
Dae Joong
DJ
Kim
Sung-Joo
SJ
Joh
Jae-Won
JW
Oh
Ha Young
HY
Huh
Wooseong
W
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*
D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D009173:Mycophenolic Acid; D016559:Tacrolimus