Tacrolimus-based dual therapy is as efficacious and safe as the conventional tacrolimus-based triple therapy in liver transplantation.

When tacrolimus was introduced as primary immunosuppressive agent for liver transplant recipients at the University of Pittsburgh in 1989, the initial results showed improved efficacy in terms of patient and graft survival and in the incidence of rejection compared to historical controls of cyclosporine-based therapy. Two subsequent large international studies (in Europe and in the United States) confirmed that tacrolimus-based immunosuppressive therapy is superior to conventional cyclosporine-based therapy in the prevention of rejection in liver transplant recipients while a similar safety profile is maintained. In the present study patients in both arms of the study started on the same dose of oral tacrolimus and corticosteroids, thus reducing variable factors. This comparison of the efficacy and safety of a dual versus a triple tacrolimus-based therapy aimed to obtain further information on the optimum tacrolimus-based regimen following liver transplantation. A total of 185 patients were enrolled into this study. Two enrolled patients did not receive study medication and were therefore excluded from the analysis; 183 patients, 90 in the dual therapy group and 93 in the triple therapy group, received study medication and were included in the intent-to-treat (ITT) cohort. Similar proportions of patients in both treatment groups completed the study (dual: 81.1%, triple: 86.0%). Eleven patients (12.2%) in the dual therapy group and seven patients (7.5%) in the triple therapy group died in the course of the study, including four patients and two patients in the dual and triple groups who died after withdrawal. This study confirmed that both tacrolimus-based dual and triple immunosuppressive regimens are efficacious and well tolerated, resulting in high patient and graft survival and low rates of acute rejection.