A pilot study on the safety and effectiveness of immunosuppression withoutprednisone after liver transplantation

Background. Corticosteroids are commonly used in the immunosuppression ther apy after Liver transplantation, yet are associated with considerable side effects. Retrospective studies have shown that corticosteroids can be safel y withdrawn from months to years after transplant. We prospectively investi gated the effects of early immunosuppression without the use of corticoster oids on graft outcome and transplant complications, Methods. Forty-five patients undergoing liver transplantation were randomiz ed to receive immunosuppression composed of cyclosporine microemulsion and azathioprine with (n=22) or without prednisone (n=23), in conventional dose s. In those patients who received prednisone, this was withdrawn within 3 m onths after transplant. The median follow-up of survivors was 14 months (ra nge: 6-24), The study end points were to determine graft survival and funct ion, infectious complications, including hepatitis C virus (HC-V)-RNA level s in HCV-infected recipients, acute rejection, kidney function, and metabol ic complications. Results, Eleven deaths occurred, 6 of which were in the prednisone group. T wo-year survival did not differ between patients treated with Or without pr ednisone (70.2% vs. 78.3%, P=0.83), nor did the causes of death. No differe nces were observed with regard to graft function, renal function, and infec tious complications. In the subset of patients who received transplants for HCV-related cirrhosis, the dynamics of virus replication HCV-RNA was faste r among those treated with prednisone, The incidence and severity of acute rejection was similar in the two groups. More than 80% of acute rejections in both groups were classified as mild or moderate and underwent spontaneou s resolution, Only two patients in each group had severe acute rejection re quiring additional treatment with high-dose steroids. Patients receiving pr ednisone tended to have greater biochemical signs of cholestasis, higher se rum cholesterol and glucose levels, and more frequent insulin requirement t han those treated without corticosteroids. Conclusions. Liver transplantation can be performed safely without using co rticosteroids in the early postoperative course, and there is no need for r outine aggressive steroid treatment of established acute rejections.