Long-term results of pancreas transplantation under tacrolimus immunosuppression

Background The long-term safety and efficacy of tacrolimus in pancreas tran splantation has not yet been demonstrated. The observation of prolonged pan creatic graft function under tacrolimus would indicate that any potential i slet toxicity is short-lived and clinically insignificant. We report herein the results of pancreas transplantation in patients receiving primary tacr olimus immunosuppression for a minimum of 2 years. Methods. From July 4, 1994 until April 18, 1996, 60 patients received eithe r simultaneous pancreas kidney transplant (n=55), pancreas transplant only (n=4), or pancreas after kidney transplantation (n=1). Baseline immunosuppr ession consisted of tacrolimus and steroids without antilymphocyte inductio n. Azathioprine was used as a third agent in 51 patients and mycophenolate mofetil in 9. Rejection episodes within the first 6 months occurred in 48 ( 80%) patients and were treated with high-dose corticosteroids, Antilymphocy te antibody was required in eight (13%) patients with steroid-resistant rej ection. Results. With a mean follow-up of 35.1+/-5.9 months (range: 24.3-45.7 month s), 6-month and 1-, 2-, and 33-year graft survival is 88%, 82%, 80%, and 80 % (pancreas) and 98%, 96%, 93%, and 91% (kidney), respectively. Six-month a nd 1-, 2-, and 3-year patient survival is 100%, 98%, 98%, and 96.5%. Mean f asting glucose is 91.6+/-13.8 mg/dl, and mean glycosylated hemoglobin is 5. 1+/-0.7% (normal range: 4.3-6.1%). Mean tacrolimus dose is 6.5+/-2.6 mg/day and mean prednisone dose 2.0+/-2.9 mg/day at follow-up. Complete steroid w ithdrawal was possible in 31 (65%) of the 48 patients with functioning panc reases. Conclusions. These data show for the first time that tacrolimus is a safe a nd effective long-term primary agent in pancreas transplantation and provid es excellent long-term islet function without evidence of toxicity while pe rmitting steroid withdrawal in the majority of patients.