Steroid avoidance versus steroid withdrawal after simultaneous pancreas-kidney transplantation.
Two steroid-sparing immunosuppressive regimens were prospectively compared in recipients of simultaneous pancreas-kidney transplants, one did not include steroids at all and the other included steroids for the first 3 months following transplantation. All patients received rabbit anti-thymocyte globulin, mycophenolate mofetil (MMF) and cyclosporine. Fifty patients were randomised in an open-label, single center and prospective study. The incidence of biopsy-proven acute rejection during the first 12 months after transplantation was the primary endpoint of the study. The incidence of biopsy-proven acute rejection was 4% in both groups. No statistically significant difference in patient (96 and 100%), kidney (96 and 100%) or pancreas (84 and 92%) survival was observed 1 year after transplantation in the steroid avoidance and steroid withdrawal groups, respectively. The total number of adverse events (including severe ones), length of hospitalization and infectious episodes did not differ between groups. Blood glucose and insulin levels, lipid profile and hemoglobin A1C levels did not differ statistically between the two groups. However, the 1-year serum creatinine level was significantly higher in the steroid avoidance group (132 vs. 114 micromol/L; p = 0.02). Steroid avoidance and steroid withdrawal 3 months after transplantation are safe and effective regimens for diabetic patients with pancreas-kidney transplants.
Cantarovich
Diego
D
Institut de Transplantation et de Recherche en Transplantation (ITERT), Centre Hospitalier et Universitaire de Nantes, France. diego.cantarovich@chu-nantes.fr
Karam
Georges
G
Hourmant
Maryvonne
M
Dantal
Jacques
J
Blancho
Gilles
G
Giral
Magali
M
Soulillou
Jean-Paul
JP
D000293:Adolescent; D000328:Adult; D000961:Antilymphocyte Serum / Q000008:administration & dosage; D016572:Cyclosporine / Q000008:administration & dosage; D003922:Diabetes Mellitus, Type 1 / Q000276:immunology / Q000473:pathology / Q000628:therapy; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000517:prevention & control*; D006085:Graft Survival; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D016035:Pancreas Transplantation / Q000276:immunology*; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D015996:Survival Rate; D014181:Transplantation Immunology; D016896:Treatment Outcome
D000961:Antilymphocyte Serum; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D011241:Prednisone