Immunosuppression without steroids in liver transplantation is safe and reduces infection and metabolic complications: results from a prospective multicenter randomized study.
OBJECTIVE
The purpose of this study was to evaluate the efficacy of a steroid-free immunosuppression protocol.


METHODS
From 2001 to 2004, 198 liver-transplant patients were randomized to receive immunosuppression with Basiliximab and cyclosporine, with (St Group) or without (NoSt Group) prednisone. The primary end points were acute rejection, and patient and graft survival. The secondary end points were infection, metabolic complications, and hepatitis C-virus recurrence.


RESULTS
Overall rejection rate was 15%, with no differences (St: 13% vs NoSt: 18%; P=0.33). Infection rate was similar in both groups (St: 51% vs NoSt: 47%; P=0.56), but diabetic patients in the St Group had a significantly higher rate of bacterial infections (St: 54% vs NoSt: 14%; P=0.005). The six-month protocol biopsies showed hepatitis C recurrence in 90% of patients, without differences between groups. Hypertension was more frequent in the St Group (St: 44% vs NoSt: 25%; P=0.006). De novo diabetes rate was higher in the St Group (month 1: St: 29% vs NoSt: 18%; P=0.06), with higher glycatedHb (5.1+/-1.1 vs 4.4+/-0.8; P=0.002). Six-month survival rates were similar (St: 89% vs NoSt: 94%, P=0.62).


CONCLUSIONS
Immunosuppression without steroids is safe and reduces infection and metabolic complications.
Department of Surgery, Liver Transplant Unit, Hospital Universitari de Bellvitge, IDIBELL, 08907 Barcelona, Spain. 31513llg@comb.es
Laura
L
Lladó
Xavier
X
Xiol
Joan
J
Figueras
Emilio
E
Ramos
Roberto
R
Memba
Teresa
T
Serrano
Jaume
J
Torras
Agustin
A
Garcia-Gil
Ignacio
I
Gonzalez-Pinto
Jose
J
Castellote
Carme
C
Baliellas
Joan
J
Fabregat
Antoni
A
Rafecas
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D000077552:Basiliximab; D016572:Cyclosporine / Q000276:immunology / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000209:etiology / Q000503:physiopathology; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D016174:Hepacivirus / Q000276:immunology; D006526:Hepatitis C / Q000188:drug therapy* / Q000209:etiology* / Q000401:mortality / Q000601:surgery; D006801:Humans; D006973:Hypertension / Q000209:etiology / Q000503:physiopathology; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008099:Liver / Q000737:chemistry / Q000473:pathology / Q000821:virology; D016031:Liver Transplantation / Q000009:adverse effects* / Q000276:immunology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000276:immunology / Q000627:therapeutic use*; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000276:immunology / Q000627:therapeutic use*; D012008:Recurrence; D013256:Steroids / Q000276:immunology / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013256:Steroids; D016572:Cyclosporine; D000077552:Basiliximab; D011241:Prednisone