A RANDOMIZED PROSPECTIVE TRIAL OF STEROID WITHDRAWAL AFTER LIVER-TRANSPLANTATION

The safety of steroid withdrawal in orthotopic liver transplant (OLT) recipients has been studied in a prospective trial with a comparison c ontrol group. Sixty-four recipients of ABO-compatible grafts (42 adult s, 22 children) were randomized into a steroid withdrawal (SW) group a nd a control group. Inclusion criteria included survival > one year po st-OLT and no rejection > six months after OLT. Exclusion criteria inc luded previous graft loss secondary to rejection, > two episodes of do cumented rejection, patients transplanted for autoimmune hepatitis, an d patients unable to receive azathioprine. Target HPLC cyclosporine le vels in both groups were 100-200 ng/ml. Thirty-three patients entered the SW group and 31 the control group at a mean of 3.5 years after OLT ; follow-ups were 592 and 527 days, respectively. Two patients in each group developed biopsy-proven rejection. In the SW group one patient rejected at three months, the other at nine months. Both rejection epi sodes resolved with only reinstitution of oral prednisone. Of the two patients who rejected in the control group (one at 7 months, one at 11 months) one required conversion to tacrolimus and the other intraveno us steroids. There were no significant differences between the two gro ups for prednisone, azathioprine, cyclosporine doses, cyclosporine lev els, liver function tests, and white blood cell counts at base line co mpared with 12 months. Easting serum cholesterol in the SW group decre ased from 194+/-44 mg/dl at baseline to 175+/-37 mg/dl at one year, wh ereas in the control group cholesterol rose from 180+/-48 mg/dl to 193 +/-44 mg/dl. In pediatric patients no significant difference in age-ad justed height velocities over one year was seen between the two groups . We concluded that dual therapy with cyclosporine and azathioprine in stable longterm liver allograft recipients is not associated with an increase in rejection incidence. Prednisone withdrawal may be associat ed with an improvement in Lipid profiles.