BACKGROUND: In Japan, the new macrolide immunosuppressant, tacrolimus, was approved for the prevention and treatment of allograft rejection in renal transplant recipients in April 1996. This article summarizes efficacy and safety data for tacrolimus gathered since its approval. METHOD: Data from 1,007 patients who received tacrolimus-based treatment after kidney transplantation at 35 leading Japanese transplant centers between April 1996 and December 2000 were retrospectively analyzed. RESULTS: The renal transplants consisted of 856 living (756 ABO compatible, 100 ABO incompatible) and 151 cadaveric (146 non-heart-beating, 5 brain dead) donor grafts. Mean follow-up duration was 24.4 months. Overall patient and graft survival rates were 98.4% and 94.8% at 1 year, 98.0% and 92.6% at 2 years, and 97.6% and 90.4% at 3 years, respectively. Graft survival rates in living and non-heart-beating donor graft transplantations were 95.9% and 88.8% at 1 year, 94.0% and 85.0% at 2 years, and 92.2% and 80.0% at 3 years, respectively. Graft survival rates in living ABO-compatible donor graft transplantation ranged from 93.4% to 97.5%, and in ABO-incompatible cases, rates were stable at 83.2% throughout the 3-year assessment period. Median serum creatinine levels ranged from 1.30 to 1.37 mg/dL during this time. Percentages of patients receiving antihyperlipidemics, antihypertensives, and insulin were 12.6%, 41.1%, and 6.5% at 1 year, respectively, and remained low at 3 years after transplantation. CONCLUSION: Three years of tacrolimus therapy demonstrated excellent efficacy and safety in more than 1,000 renal transplant recipients, including recipients of living ABO-incompatible and non-heart-beating donor grafts, with favorable graft function maintained.
BACKGROUND: In Japan, the new macrolide immunosuppressant, tacrolimus, was approved for the prevention and treatment of allograft rejection in renal transplant recipients in April 1996. This article summarizes efficacy and safety data for tacrolimus gathered since its approval. METHOD: Data from 1,007 patients who received tacrolimus-based treatment after kidney transplantation at 35 leading Japanese transplant centers between April 1996 and December 2000 were retrospectively analyzed. RESULTS: The renal transplants consisted of 856 living (756 ABO compatible, 100 ABO incompatible) and 151 cadaveric (146 non-heart-beating, 5 brain dead) donor grafts. Mean follow-up duration was 24.4 months. Overall patient and graft survival rates were 98.4% and 94.8% at 1 year, 98.0% and 92.6% at 2 years, and 97.6% and 90.4% at 3 years, respectively. Graft survival rates in living and non-heart-beating donor graft transplantations were 95.9% and 88.8% at 1 year, 94.0% and 85.0% at 2 years, and 92.2% and 80.0% at 3 years, respectively. Graft survival rates in living ABO-compatible donor graft transplantation ranged from 93.4% to 97.5%, and in ABO-incompatible cases, rates were stable at 83.2% throughout the 3-year assessment period. Median serum creatinine levels ranged from 1.30 to 1.37 mg/dL during this time. Percentages of patients receiving antihyperlipidemics, antihypertensives, and insulin were 12.6%, 41.1%, and 6.5% at 1 year, respectively, and remained low at 3 years after transplantation. CONCLUSION: Three years of tacrolimus therapy demonstrated excellent efficacy and safety in more than 1,000 renal transplant recipients, including recipients of living ABO-incompatible and non-heart-beating donor grafts, with favorable graft function maintained.