Long-term outcome after switch from cyclosporine-based triple-drug immunosuppression to double therapy at three months.

Cyclosporin A (CyA) together with steroids and azathioprine (Aza) has been successfully used for prophylactic immunosuppression in numerous recipients of kidney allografts. The aim of this study was to evaluate the long-term effect of reducing this initial triple-drug therapy to double-drug therapy at 3 months. One hundred consecutive recipients of a cadaveric renal allograft with stable and good graft function were randomly allocated to continue with CyA and steroids (group 1) or CyA and Aza (group 2). Both groups were comparable with regard to all relevant patient characteristics. After a mean observation period of 55 (26-76) months no significant difference was observed in the incidence of acute rejection episodes after conversion (4 in group 1 and 5 in group 2), or in the incidence of graft loss (4 in group 1 and 5 in group 2); all graft rejection episodes were easily reversed with steroid pulses and patients switched back to triple-drug therapy. Patient survival was 94% in group 1 and 100% in group 2 at 55 months. In group 1, however, a higher number of viral infections and steroid-related side effects was noted. From these data it is concluded that initial triple-drug therapy can safety be reduced to a CyA-based double-drug combination after 3 months in renal allograft recipients with stable function. The combination with Aza is recommended because of its fewer side effects.