IMMUNOSUPPRESSION FOR LIVER TRANSPLANTATION

N. Weiler¹, M. Hoppe-lotichius¹, T. Zimmermann², I. Kraemer², G. Otto^1
1Transplantation And Hepatobiliary Surgery, University Medical Center, Mainz/GERMANY, ², University Medical Center, Mainz/GERMANY

Body: Introduction: Aim of this prospective randomized double-blinded placebo-controlled single center study was, to evaluate an early steroid-free immunosuppressive therapy in liver transplant patients.Methods: From March 2000 and October 2004 110 patients were included in this study. Demographics and underlying diseases were comparable in both groups. All patients received the sameimmunosuppressive therapy with FK 506 and steroids during the first two weeks after liver transplantation. Steroids were tapered down from 500mg during surgery to 12mg until day 14. The 54 patientsin the steroid group got 12mg from day 14 until day 60 and 8mg from day 60 until day 180. The other 56 patients received a Placebo from day 14 until day 180. After 6 months the immunosuppressivetherapy for all 110 patients was steroid free. Five years after finishing the study all patients were re-evaluated in terms of survival, organ survival, steroid side effects and the HCV-patients as asubcategory in terms of HCV- recurrence and re-cirrhosis. Results: After 5 years the following parameters were comparable in both groups: Patient survival (p=0.236), organ survival (p=0.509), timefree from rejection (p=0.214), rejections after randomization (p=0.409). There was a significant difference 6 months after OLT in rates of PTDM (p=0.024) and hypercholesterolemia (p=0.002). However,after 5 years there is no difference in steroid side effects in both groups: hypertension (p=0.499), PTDM (p=0.638), hypercholesterolemia (p=0.763), osteoporosis (p= 0.624). Thirty HCV-patients wereincluded in this study, 14 in the placebo group, 16 in the steroid group. Demographics were comparable in both groups. We could find no differences in survival (p=0.096), organ survival (p=0.424),time free from re-cirrhosis (p = 0.647). The rate of re-cirrhosis in HCV-patients was significantly influenced by steroid bolus therapy (p = 0.01), but not by avoiding continuous steroid therapy inthe placebo group. Conclusion: Early withdrawal of steroids resulting in tacrolimus mono-therapy is possible and safe with equal rejection rates. PTDM and hypercholesterolemia are encountered duringsteroid treatment. These side effects are reversible. Re-cirrhosis in HCV-patients is not influenced by steroid baseline therapy in the steroid group, but by steroid bolus treatment.

Disclosure: All authors have declared no conflicts of interest.