Steroid withdrawal at day 14 after liver transplantation: a double-blind, placebo-controlled study.
Some clinical studies in liver transplantation have recently reported safety advantages and similar acute rejection rates with early steroid withdrawal. The aim of this study was to evaluate the efficacy and safety of an immunosuppressive regimen with steroid withdrawal at day 14. A multicenter, 1-year, comparative, double blind, placebo-controlled study was performed. Patients undergoing a first cadaveric liver transplantation were recruited and all received basiliximab + cyclosporine + intravenous methylprednisolone. Patients without severe postoperative complications were randomized at day 7 to receive a maintenance regimen with Neoral (cyclosporine) + prednisolone (group 1) or without steroids (Neoral + placebo; group 2), after a 7-day blinded oral steroid tapering period. A total of 174 patients were randomized at day 7 (group 1: n = 90; group 2: n = 84). The incidence of biopsy-confirmed and treated acute rejection at 6 months was 38.1% in group 2 vs. 24.4% in group 1 (P = .03) with a trend for a higher incidence of Grade II / III acute rejection (28.6% vs. 18.9%; P = .12). Changes from baseline were similar with regard to metabolic parameters (glycemia, total cholesterol, and triglycerides). A trend toward a better glucose tolerance was observed, as fewer patients received an antidiabetic treatment in the placebo group (2 vs. 10). In conclusion, this first double-blind, placebo-controlled study of steroid withdrawal at day 14 showed a higher incidence of acute rejection, only balanced by a trend of a lower need of antidiabetic treatment.
Pageaux
Georges-Philippe
GP
CHU St-Eloi, Montpellier, France. gp-pageaux@chu-montpellier.fr <gp-pageaux@chu-montpellier.fr>
Calmus
Yvon
Y
Boillot
Olivier
O
Ducerf
Christian
C
Vanlemmens
Claire
C
Boudjema
Karim
K
Samuel
Didier
D
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D011182:Postoperative Care; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D008775:Methylprednisolone