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‐y...
Saved in:
Published in | Liver transplantation Vol. 10; no. 12; pp. 1454 - 1460 |
---|---|
Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken
Wiley Subscription Services, Inc., A Wiley Company
01.12.2004
|
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | 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. (Liver Transpl 2004;10:1454–1460.) |
---|---|
Bibliography: | Telephone: 00 33 4 67 33 73 81; FAX: 00 33 4 67 52 38 97 The members of the French CHI‐F‐01 Group are: C. Vanlemmens, J.P. Miguet, and G. Mantion (Besançon); M. Neau‐Cranssac and J. Saric (CHU Bordeaux); L. Chiche, G. Lebreton, and P. Segol (CHU Caen); C. Duvoux and D. Cherqui (CHU Créteil); N. Declerck and F.R. Pruvot (CHU Lille); C. Ducerf (CHU Lyon Croix Rousse); O. Boillot and J. Dumortier (CHU Lyon Edouard Herriot); Y. Le Treut and J. Hardwigsen (CHU Marseille); G.P. Pageaux, F. Navarro, and M. Bismuth (CHU Montpellier); J. Gugenheim (CHU Nice); F. Durand and J. Belghiti (CHU Paris Beaujon); Y. Calmus and F. Conti (CHU Paris Cochin); K. Boudjema (CHU Rennes); L. Rostaing and D. Durand (CHU Toulouse); and D. Samuel and F. Saliba (CHU Villejuif). ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23 |
ISSN: | 1527-6465 1527-6473 |
DOI: | 10.1002/lt.20291 |