Department of Nephrology, Hospital Cruces. Spain.

Introduction:Tacrolimus (FK) is a new inmunossupresor which could be an alternative to Cycloporine (CyA). We compared the efficacy and safety of FK vs CyA in a triple therapy with Mycophenolate(MMF) and Corticosteroids.

Methods: A total of 100 patients were enrolled in two groups: 50 consecutive patiens in 1997 received induction therapy whit CyA (8mg/kg/day), MMF (2000 mg/day) and corticosteroids (1mg/kg/day), and another 50, in 1998-99, received FK (0,20 mg/kg/day), MMF (1500 mg/day) and corticosteroids (1mg/kg/day). Demographics data and primary diagnosis were comparable. Survival, incidence of rejections, infections and other adverse events were evaluated at 6 months.

Results: The incidence of acute rejection in FK group was 18% vs 12% in CyA group (p=ns). Two patiens in CyA group need OKT3 and none in FK group. The patient and graft survival was respectively in CyA (90% and 88%) and in FK ( 98% and 92%). Five patients died in CyA group (4 sepsis, 1 linfoma) and 1 patient (arrhythmia) in FK goup. Acute tubular necrosis was 20% in CyA vs 28% in FK goup, there were no difference in duration of ATN. The mean serum creatinine values at six months were: 1,6 mg/dL in CyA and 1,75 mg/dL in FK. The incidence of CMV infection was 28% in CyA vs 16% in FK. Leukopenia (26% in CyA vs 10% in FK). In FK group 18% of petients developed diabetes and only 2% in CyA group.

Conclusions: Our results suggest that both therapies have an similar efficacy in acute rejection prevention. The incidence of diabetes postransplant was higher in FK group.. Leukopenia and CMV infection were more frequents in FK group, that cuould be explained by higher doses of MMF used in this patients..