Steroid withdrawal at day 14 after liver transplantation: A double‐blind, placebo‐controlled study

作者: Georges‐Philippe Pageaux , Yvon Calmus , Olivier Boillot , Christian Ducerf , Claire Vanlemmens

DOI: 10.1002/LT.20291

关键词: RegimenGastroenterologyRandomized controlled trialLiver transplantationIncidence (epidemiology)MedicinePrednisoloneBasiliximabPlacebo-controlled studyPlaceboSurgeryInternal medicine

摘要: 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 an immunosuppressive regimen withdrawal at day 14. A multicenter, 1-year, comparative, double blind, placebo-controlled performed. Patients undergoing a first cadaveric were recruited all received basiliximab + cyclosporine intravenous methylprednisolone. without severe postoperative complications randomized 7 receive maintenance Neoral (cyclosporine) prednisolone (group 1) or steroids (Neoral placebo; group 2), after 7-day blinded oral tapering period. total 174 patients 1: n = 90; 2: 84). incidence biopsy-confirmed treated 6 months 38.1% 2 vs. 24.4% 1 (P .03) trend for higher Grade II / III (28.6% 18.9%; P .12). Changes from baseline regard metabolic parameters (glycemia, cholesterol, triglycerides). toward better glucose tolerance observed, as fewer antidiabetic treatment placebo (2 10). In conclusion, double-blind, 14 showed rejection, only balanced by lower need treatment.

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