Early Steroid-Free Immunosuppression With FK506 After Liver Transplantation: Long-Term Results of a Prospectively Randomized Double-Blinded Trial

Background. The aim of this prospective, randomized, double-blinded, placebo-controlled single center study was to evaluate an early steroid-free immunosuppression in liver transplant patients. Methods. From March 2000 to October 2004, 110 patients were included. All patients received tacrolimus and steroids during the first 2 weeks after orthotopic liver transplantation (OLT). Thereafter, patients in the steroid group (n = 54) received steroids and the remaining 56 a placebo. After 6 months, the immunosuppression for all was steroid free. Thirty patients were hepatitis C positive. Five years after inclusion, patient survival, organ survival, steroid side effects, and recirrhosis in hepatitis C virus (HCV) patients were reevaluated. Results. After 5 years, the following parameters were comparable in both groups: patient survival (P = 0.236), organ survival (P = 0.509), and acute rejections (P = 0.409). Steroid-free immunosuppression lead to a higher rate of chronic rejections (P = 0.023). Six months after OLT, there was a difference in rates of posttransplant diabetes mellitus (PTDM) (P = 0.024) and hypercholesterolemia (P = 0.002). However, 5 years after OLT, there was no difference in hypertension (P = 0.647), PTDM (P = 0.453), hypercholesterolemia (P = 0.412), and osteoporosis (P = 0.624). In HCV patients, we could not find any differences in patient survival (P = 0.096), organ survival (P = 0.424), time free from recirrhosis (P = 0.647). The rate of recirrhosis was influenced by steroid bolus therapy (P = 0.01) but not by avoiding continuous steroid therapy. Conclusions. Early tapering down of steroids to a tacrolimus monotherapy is possible with comparable acute rejection rates. During steroid therapy, PTDM and hypercholesterolemia are cumulative. These side effects are reversible. The recirrhosis in HCV patients is not influenced by continuous steroid therapy but more frequent in HCV patients receiving a steroid bolus therapy.