A RANDOMIZED TRIAL COMPARING TRIPLE-DRUG AND DOUBLE-DRUG - THERAPY INRENAL-TRANSPLANTATION - ANALYSIS AT 7 YEARS

This is the 7-year update of a randomized trial comparing triple (TT) and double (DT) immunosuppressive therapy in renal transplantation. At 7 years, patient survival rate was 85% in DT vs. 87% in TT (P=NS); gr aft survival rate was 73% in DT and 68% in TT (P=NS); pure graft survi val was 86% in DT vs. 77% in TT (P=0.096). The 7-year graft survival r ate was 67% for cadaver graft recipients vs. 92% for living-related gr aft recipients (P=0.044). No difference in the slopes of plasma creati nine between the two groups was observed. Ten DT and 13 TT patients ch anged their original therapy: statistical analysis, however, was carri ed out according to intention to treat. Both CsA levels and doses were significantly higher in DT than in TT group (P<0.001) at any time poi nt up to the 7th year. At univariate analysis, a living-related donor kidney (P=0.044) and immediate recovery of renal function (P<0.001) we re the only two parameters associated with graft survival at 7 years. At multivariate analysis, only early graft function recovery was corre lated with late graft survival (RR=10.480). Thus, even in the long-ter m, there is no difference between DT and TT, either in patient or in g raft survival: at the doses we used, TT had a lower prevalence of late side effects than DT, however, long-term pure graft survival was bett er, although not significantly, in DT than in TT. The possibility of a safe shift from one regimen to the other one makes the two treatments complementary rather than alternatives.