TERAPIA CON INIBITORI DEL SEGNALE DI PROLIFERAZIONE (PSI) NEL TRAPIANTO DE NOVO DI FEGATO: UNO STUDIO MULTICENTRICO RANDOMIZZATO

In the context of organ transplantation, one of the major elements of debate still remains development of new schemes of immunosuppression to allow, on the one hand, good results in terms of patient and graft survival and, secondly, a reduction of the side effects normally associated with the use of immunomodulatory drugs. In particular, the use of calcineurin inhibitors (CNI) - currently considered the standard in immunosuppressive therapy of solid organ transplantation - is associated with a reduced risk of rejection, but with a significant frequency of side effects. The CNI may result in decreased renal function, neurotoxicity, increased cardiovascular risk and the development of post-transplant diabetes mellitus. The complete elimination of this group of drugs [cyclosporine (CsA) or tacrolimus (TAC)], especially in the early post-transplant period, has not yet been possible until now if not increasing the risk of acute rejection of the organ itself. Unlike previous immunosuppressants, however, the Everolimus (EVL) belongs to a new class of anti-rejection drugs, so-called inhibitors of proliferation signal (PSI). Among the PSI, Everolimus (EVL) is an active metabolite (40-O-(2-ideossietil)) semisynthetic derivative of rapamycin, a macrolide antibiotic obtained from Streptomyces hygroscopicus, is an inhibitor of the signal and has as target the mechanisms of action of T cell proliferation; moreover is able to increase the effect of CNI in the modulation of growth factors of lymphocytes T. In that light it is our intention to evaluate the feasibility and effectiveness of the use of everolimus (EVL) and in minimizing any suspension of CNI in adult liver transplant recipients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids)