EARLY CYCLOSPORINE MONOTHERAPY IN LIVER-TRANSPLANTATION - A 5-YEAR FOLLOW-UP OF A PROSPECTIVE, RANDOMIZED TRIAL

Maintenance of adequate immunosuppression and avoidance of side-effect s are the goals of long-term management of all organ-transplanted pati ents. We here report the final results of a prospective, randomized tr ial comparing early cyclosporine monotherapy versus double-drug therap y (cyclosporine and steroids) in adult liver transplantation patients. One hundred four patients were randomized 3 months after transplantat ion either to continue (Group I = 50 patients) or to stop steroids (Gr oup II = 54 patients). Patients on a double-drug regimen were maintain ed long term on methylprednisolone at a dose of 0.1 mg/kg/d. Target cy closporine trough levels were between 150 and 250 ng/mL in both groups . Our main points of interest were the prevalence of acute and chronic rejections and steroid-related side-effects in the two groups of pati ents. Mean follow-up was 41 +/- 16 months (range, 4-68 months), Patien t actuarial survival 2 and 5 years after randomization was similar in the two groups (82% vs. 83% and 82% vs. 77%), The prevalence of acute rejections after randomization was, respectively, 8% and 4%. A single episode of chronic rejection was observed only in a patient on longter m steroid therapy. Side-effects of steroid therapy were less frequent in patients weaned off steroids, and when considering hypertension and diabetes, the differences between the two groups were statistically s ignificant. Early cyclosporine monotherapy is a safe undertaking in li ver transplantation because it allows a significant reduction of stero id-related side-effects without increasing the risk of acute and chron ic rejection. After 5 years, patient survival was similar in patients with or Without steroids.