Neoral versus prograf in simultaneous pancreas-kidney transplantation with portal venous drainage: three-year results of a single-center, open-label, prospective, randomized pilot study.
BACKGROUND
The preferential use of tacrolimus (Prograf) over cyclosporine microemulsion (Neoral) in simultaneous pancreas-kidney transplantation (SPKTx) is mainly based on historical, retrospective studies. We herein report the 3-year results of a single-center, prospective, randomized comparison of the two calcineurin inhibitors in the setting of mycophenolate mofetil (MMF)-based immunosuppression and portal drainage of pancreas allografts.


METHODS
Between May 2001 and August 2004, 47 SPKTx recipients who were stratified by recipient sex, were alternatively assigned to treatment with Neoral (n = 22) or Prograf (n = 25). Concurrent immunosuppression included induction treatment with basiliximab and maintenance with MMF and steroids.


RESULTS
After a median follow-up of 24.0 months, all patients remained in the study arm into which they were initially enrolled. No pancreas rejection episode was observed. One acute kidney rejection was recorded in the Neoral arm (4.5%) as compared with 7 (28.0%) including one steroid-resistant episode, in the Prograf arm (P = .03). The cumulative incidence of adverse events was 31.8% (n = 7) in the Neoral arm compared with 92.0% (n = 23) in the Prograf arm (P < .0001). One patient died in each study arm. Patient, pancreas, and kidney survivals overlapped at 1- and 3-years posttransplant, namely all 95.4% for the Neoral arm compared with 95.8%, 91.8%, and 95.8%, respectively, for the Prograf arm (P > .05).


CONCLUSIONS
We conclude that in MMF-based immunosuppression there is no convincing evidence that Prograf should be preferred to Neoral in SPKTx.
Boggi
U
U
Division of Surgery in Uremic and Diabetic Patients, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. u.boggi@med.unipi.it
Vistoli
F
F
Del Chiaro
M
M
Signori
S
S
Amorese
G
G
Vahadia Bartolo
T
T
Sgambelluri
F
F
Barsotti
M
M
Tregnaghi
C
C
Paleologo
G
G
Coppelli
A
A
Giannarelli
R
R
Rizzo
G
G
Marchetti
P
P
Mosca
F
F
D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents; D016030:Kidney Transplantation / Q000276:immunology*; D007902:Length of Stay; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D016035:Pancreas Transplantation / Q000276:immunology*; D010865:Pilot Projects; D011168:Portal System / Q000502:physiology*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D016559:Tacrolimus; D008775:Methylprednisolone