Early steroid withdrawal in renal transplantation with tacrolimus dual therapy: a pilot study.
BACKGROUND
With tacrolimus-based immunosuppression, it appears safe to withdraw steroids 3 to 6 months after renal transplantation. We hypothesized whether steroids could also be safely withdrawn early after transplantation.


METHODS
Sixty-two patients (first or second transplant, with no previous immunological failure, and current panel reactive human leucocyte antigen [HLA] antibodies [PRA]<50%), treated with tacrolimus, were prospectively randomized to stop steroids (10 mg prednisolone) after day 7 posttransplantation (stop group [STOP], n=28) or to gradually wean off steroids in 3 to 6 months (tapering group [TAP], n=34). Analyses were performed on an intention-to-treat basis.


RESULTS
After a median follow-up of 2.7 years, patient and graft survival were 97 and 90% and comparable between both groups (P =0.11 and P=0.13, respectively). The incidence of acute rejection was 29 (STOP) versus 33% (TAP) ( P=0.30). The time to the first rejection was a median of 35 days (STOP) versus 11 days (TAP) ( =0.19). The severity of the rejections (1997 Banff classification) was comparable (P =0.57). Creatinine clearance and proteinuria were similar (P >0.70). The incidence of infections was comparable ( P>0.10). The incidence of new-onset diabetes mellitus, defined as the use of antidiabetic medication, was 8.0 (STOP) versus 30.3% (TAP) (P =0.04). All cases occurred in the STOP group after 1 year, while all cases occurred in TAP in the first 4 months ( P<0.001).


CONCLUSIONS
Compared with tapering in 3 to 6 months, stopping steroids 1 week posttransplantation results in comparable patient and graft survival and in a similar incidence of acute rejections. The incidence of new-onset diabetes may be reduced. The immunosuppressive benefit of adding 10 mg prednisolone to tacrolimus seems to be limited.
Boots
Johannes M M
JM
Department of Nephrology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands. jboo@groupwise.azm.nl.
Christiaans
Maarten H L
MH
Van Duijnhoven
Elly M
EM
Van Suylen
Robert-Jan
RJ
Van Hooff
Johannes P
JP
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003404:Creatinine / Q000378:metabolism; D003920:Diabetes Mellitus / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy* / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D015994:Incidence; D007239:Infections / Q000453:epidemiology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology; D011239:Prednisolone / Q000008:administration & dosage*; D011446:Prospective Studies; D011507:Proteinuria / Q000453:epidemiology; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage*
D000893:Anti-Inflammatory Agents; D011239:Prednisolone; D003404:Creatinine; D016559:Tacrolimus