Immunosuppression without steroids in liver transplantation is safe and reduces infection and metabolic complications: Results from a prospective multicenter randomized study

• Published in: Journal of hepatology Vol. 44; no. 4; pp. 710 - 716
• Main Authors: Lladó, Laura, Xiol, Xavier, Figueras, Joan, Ramos, Emilio, Memba, Roberto, Serrano, Teresa, Torras, Jaume, Garcia-Gil, Agustin, Gonzalez-Pinto, Ignacio, Castellote, Jose, Baliellas, Carme, Fabregat, Joan, Rafecas, Antoni, the THOSIN Study Group
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.04.2006; Elsevier
• Subjects: Adult; Adverse events; Aged; Antibodies, Monoclonal - immunology; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; Cyclosporine - immunology; Cyclosporine - therapeutic use; Diabetes Mellitus - etiology; Diabetes Mellitus - physiopathology; Drug Therapy, Combination; Female; Gastroenterology. Liver. Pancreas. Abdomen; Graft Rejection; Graft Survival; Hepacivirus - immunology; Hepatitis C - drug therapy; Hepatitis C - etiology; Hepatitis C - mortality; Hepatitis C - surgery; Humans; Hypertension - etiology; Hypertension - physiopathology; Immunosuppression - methods; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - immunology; Immunosuppressive Agents - therapeutic use; Liver - chemistry; Liver - pathology; Liver - virology; Liver transplantation; Liver Transplantation - adverse effects; Liver Transplantation - immunology; Liver Transplantation - mortality; Liver, biliary tract, pancreas, portal circulation, spleen; Male; Medical sciences; Middle Aged; Prednisone - immunology; Prednisone - therapeutic use; Prospective Studies; Recombinant Fusion Proteins - immunology; Recombinant Fusion Proteins - therapeutic use; Recurrence; Rejection; Steroids; Steroids - immunology; Steroids - therapeutic use; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Survival Rate; Treatment Outcome; Rejection; Adverse events; Liver transplantation; Steroids; Infection; Steroid; Graft(material); Immunosuppression; Gastroenterology; Complication
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2005.12.010

The purpose of this study was to evaluate the efficacy of a steroid-free immunosuppression protocol. 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. 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). Immunosuppression without steroids is safe and reduces infection and metabolic complications.