Tacrolimus versus cyclosporine after lung transplantation: A prospective, open, randomized two-center trial comparing two different immunosuppressiveprotocols

Background: The need for better immunosuppressive protocols after lung tran splantation led us to investigate tacrolimus (Tac) in combination with myco phenolate mofetil (MMF) and steroids or cyclosporine (CsA) in combination w ith MMF and steroids in a prospective, open, randomized trial after lung tr ansplantation. Methods: Between September 1997 and April 1999, 50 lung transplant recipien ts were randomized to receive either Tac (n = 26) or CsA (n = 24) in combin ation with MMF and steroids. All patients underwent induction therapy with rabbit antithymocyte globulin (ATG) for 3 days. Freedom from acute rejectio n (AR), patient survival, infection episodes, and side effects were monitor ed. Results: There was no difference in patient demographics between the two gr oups. Six-month and 1-year survival was similar (84.6% and 73.1% in the Tac group vs 83.3% and 79.2% in the CsA group). Freedom from AR at 6 months an d 1 year after lung transplantation was slightly higher in the Tac group (5 7.7% and 50% vs 45.8% and 33.3%, p = not significant [n.s.]), whereas the n umber of treated rejection episodes per 100 patient days in the Tac group w as significantly lower (0.225 vs 0.426, p <.05). Four patients in the CsA g roup had to be switched to Tac. Two patients in the CsA group had to be ret ransplanted. Incidence of infections was similar in both groups with a tren d toward more fungal infections in the Tac group (n = 7 vs n = 1, p = n.s.) . Conclusions: The combination of Tac and MMF seems to have slightly higher i mmunosuppressive potential compared with CsA and MMF. The effectiveness of Tac as a rescue agent is not paralleled with undue signs of overimmunosuppr ession.