High rejection rate during calcineurin inhibitor-free and early steroid withdrawal immunosuppression in renal transplantation.
Morbidity and mortality due to cardiovascular disease are major problems after renal transplantation. The effects of three immunosuppressive protocols on cardiovascular end points were investigated in a single-center, randomized, parallel (1-1-1) group. Acute rejection was a secondary safety endpoint. Groups were as follows: group one, tacrolimus+sirolimus; group two, tacrolimus+mycophenolate mofetil (MMF); group three, sirolimus+MMF+daclizumab. All groups received two days methylprednisolone only. The Ethical Committee demanded an interim analysis when 50% of the patients were included. In this analysis, 54 patients with a median follow-up of 9.2 months were studied. The Kaplan-Meyer analysis showed a difference in rejection free survival between group one (82%) and group three (34%, P=0.03) and between groups one and two (tacrolimus-based, 76%) and group three (calcineurin-free, 34%, P=0.04). Calcineurin-free immunosuppression with two days of steroids only showed an unacceptable high incidence of acute rejection and re-rejection, and the study had to be stopped.
Gelens
Marielle A C J
MA
Department of Internal Medicine, University Hospital Maastricht, the Netherlands. mgel@sint.azm.nl
Christiaans
Maarten H L
MH
van Heurn
Ernst L W
EL
van den Berg-Loonen
Ella P M
EP
Peutz-Kootstra
Carine J
CJ
van Hooff
Johannes P
JP
D000328:Adult; D065095:Calcineurin Inhibitors; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D013256:Steroids / Q000627:therapeutic use; D017211:Treatment Failure
D065095:Calcineurin Inhibitors; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D013256:Steroids; D008775:Methylprednisolone