R H Wiesner1. 1. Mayo Clinic, Rochester, Minnesota 55905, USA.
Abstract
BACKGROUND: The long-term (5 year) efficacy and safety of tacrolimus (FK506) and cyclosporine were compared in primary liver transplant recipients who participated in a 1-year randomized, multicenter trial and a 4-year follow-up extension study. METHODS: A total of 529 patients (263 tacrolimus group, 266 cyclosporine group) were randomized to study drug. Patients were evaluated at 3-month intervals. Patient and graft survival rates, incidence of adverse events, and changes in laboratory and clinical profiles were determined. RESULTS:Cumulative 5-year patient and graft survival rates were comparable for the tacrolimus (79.0%, 71.8%) and cyclosporine (73.1%, 66.4%) groups. However, patient half-life survival was longer for tacrolimus-treated patients (25.1+/-5.1 years versus 15.2+/-2.5 years; P=0.049). Improved patient survival with tacrolimus was also observed for hepatitis C-positive patients (78.9% tacrolimus group versus 60.5% cyclosporine group; P=0.041). Both treatments were associated with a low incidence of late acute rejection, late steroid-resistant rejection, and death or graft loss related to rejection. Both treatments demonstrated an acceptable safety profile with maintenance of adequate renal and liver function and a low incidence of malignancy/lymphoproliferative disease and serious infections. CONCLUSIONS:Tacrolimus is a safe and effective long-term maintenance immunosuppressive agent in primary liver transplantation.
RCT Entities:
BACKGROUND: The long-term (5 year) efficacy and safety of tacrolimus (FK506) and cyclosporine were compared in primary liver transplant recipients who participated in a 1-year randomized, multicenter trial and a 4-year follow-up extension study. METHODS: A total of 529 patients (263 tacrolimus group, 266 cyclosporine group) were randomized to study drug. Patients were evaluated at 3-month intervals. Patient and graft survival rates, incidence of adverse events, and changes in laboratory and clinical profiles were determined. RESULTS: Cumulative 5-year patient and graft survival rates were comparable for the tacrolimus (79.0%, 71.8%) and cyclosporine (73.1%, 66.4%) groups. However, patient half-life survival was longer for tacrolimus-treated patients (25.1+/-5.1 years versus 15.2+/-2.5 years; P=0.049). Improved patient survival with tacrolimus was also observed for hepatitis C-positivepatients (78.9% tacrolimus group versus 60.5% cyclosporine group; P=0.041). Both treatments were associated with a low incidence of late acute rejection, late steroid-resistant rejection, and death or graft loss related to rejection. Both treatments demonstrated an acceptable safety profile with maintenance of adequate renal and liver function and a low incidence of malignancy/lymphoproliferative disease and serious infections. CONCLUSIONS:Tacrolimus is a safe and effective long-term maintenance immunosuppressive agent in primary liver transplantation.
Authors: Egbert Sieders; Paul M J G Peeters; Elisabeth M TenVergert; Koert P de Jong; Robert J Porte; Jan H Zwaveling; Charles M A Bijleveld; Annette S H Gouw; Maarten J H Slooff Journal: Ann Surg Date: 2002-01 Impact factor: 12.969
Authors: Jacqueline G O'Leary; James F Trotter; Michael A Neri; Linda W Jennings; Greg J McKenna; Gary L Davis; Göran B Klintmalm Journal: Proc (Bayl Univ Med Cent) Date: 2011-07
Authors: Mohamad A Mouchli; Siddharth Singh; Edward V Loftus; Lisa Boardman; Jayant Talwalkar; Charles B Rosen; Julie K Heimbach; Russell H Wiesner; Bashar Hasan; John J Poterucha; Watt D Kymberly Journal: Transplantation Date: 2017-08 Impact factor: 4.939