Mean Tacrolimus Levels Research Articles

Posttransplant diabetes mellitus in pediatric thoracic organ recipients receiving tacrolimus-based immunosuppression.

Posttransplantation diabetes mellitus (PTDM) is a well-known complication of tacrolimus-based immunosuppression in both adult and pediatric solid organ recipients. The "natural history" of diabetes in the pediatric thoracic transplant population has not yet been described. We identified all pediatric thoracic transplant patients receiving tacrolimus-based immunosuppression who developed PTDM. Medical records were reviewed, with a particular focus on the clinical course of PTDM and its relationship to drug weaning. Diabetes developed in 24 of 143 (17%) 30-day survivors of heart (12/96, 13%) and heart-lung/lung (12/ 47, 26%) transplantation. In 17 (71%) patients, the immunosuppressive regimen at the onset of PTDM also included maintenance corticosteroids. Seventeen patients demonstrated glucose intolerance before the onset of diabetes. Nine patients (38%) developed diabetes during pulsed corticosteroid therapy. Median time of onset after transplantation was 9.0 months. All patients required s.c. insulin for glucose control. The median follow-up from transplant was 49.9 months. There was a significant decrease in mean tacrolimus dosage (P<0.01), tacrolimus level (P<0.04), and steroid dosage (P<0.02) from onset of PTDM to most recent follow-up. Despite this significant reduction in immunosuppression, only 3/24 (13%) patients were successfully weaned off insulin. Diabetes mellitus is a common complication in pediatric thoracic transplant patients receiving tacrolimus-based immunosuppression. Insulin dependence in our population rarely resolved, even after lowering tacrolimus and steroid doses. Discontinuation of steroids did not guarantee resolution of diabetes.

Outcome of Kidney Transplantation under Tacrolimus-Based Immunosuppression in Elderly Patients

Kidney transplantation has become a reasonable treatment option for selected patients aged 60 years or older, and a number of different immunosuppressive drug protocols have been described. This article concerns 230 recipients who were aged 60 years or older and who were undergoing kidney-only transplantation at the University of Pittsburgh between January 1990 and April 1997. All recipients were treated with a tacrolimus-based immunosuppression regimen. The median follow-up was 31.5 months (range, 1–86). The 1-, 3-, and 5-year actuarial patient survival rates were 90%, 83%, and 76%, respectively. There were 42 (19%) deaths, cardiovascular disease (50%) and infection (38%) being the main causes. Death with a functioning kidney occured in 28 (67%) patients. The 1-, 3-, and 5-year actuarial graft survival rates were 84%, 74%, and 64%, respectively. The delayed graft function rate was 33%. Rejection was seen in 57 (25%) elderly patients. The mean serum creatinine was 2.6±2.7 mg/dL and the serum urea nitrogen was 35±22 mg/dL. The mean tacrolimus level was 8.5±3.8 ng/mL. These results suggest that renal transplantation in older recipients under tacrolimus-based immunosuppression is associated with reasonable outcomes, and can be offered to appropriately selected patients.

Outcome of kidney transplantation under tacrolimus-based immunosuppression in elderly patients.

Kidney transplantation has become a reasonable treatment option for selected patients aged 60 years or older, and a number of different immunosuppressive drug protocols have been described. This article concerns 230 recipients who were aged 60 years or older and who were undergoing kidney-only transplantation at the University of Pittsburgh between January 1990 and April 1997. All recipients were treated with a tacrolimus-based immunosuppression regimen. The median follow-up was 31.5 months (range, 1-86). The 1-, 3-, and 5-year actuarial patient survival rates were 90%, 83%, and 76%, respectively. There were 42 (19%) deaths, cardiovascular disease (50%) and infection (38%) being the main causes. Death with a functioning kidney occurred in 28 (67%) patients. The 1-, 3-, and 5-year actuarial graft survival rates were 84%, 74%, and 64%, respectively. The delayed graft function rate was 33%. Rejection was seen in 57 (25%) elderly patients. The mean serum creatinine was 2.6 +/- 2.7 mg/dL and the serum urea nitrogen was 35 +/- 22 mg/dL. The mean tacrolimus level was 8.5 +/- 3.8 ng/mL. These results suggest that renal transplantation in older recipients under tacrolimus-based immunosuppression is associated with reasonable outcomes, and can be offered to appropriately selected patients.

A prospective, randomized trial of tacrolimus/prednisone vs tacrolimus/prednisone/mycophenolate mofetil in renal transplantation: 1-year actuarial follow-up

BETWEEN September 10, 1995, and September 20, 1997, a total of 208 adult patients undergoing their first or second cadaveric renal transplantation alone were randomized to receive tacrolimus!prednisone (n = 106) or tacrolimus/prednisone/mycophenolate mofetil (n = 102), without induction antilymphocyte antibody therapy. The mean recipient age was 50.8 ::!:: 13.7 years (range 19 to 84). Thirty-one (14.9%) patients were undergoing their second transplant, and 11 (5.3%) had a panel-reactive antibody level of over 40%. Sixty-three (30.3%) patients were 60 years of age or older at the time of transplantation, and 16 (7.7%) patients had undergone previous liver or heart transplantation. The mean donor age was 34.5 ::!:: 21.7 years (range 0.01 to 76.5). Twenty-eight (13.5%) donors were 60 years of age or older, and 25 (12.0%) donors were 3 years of age or younger, and were transplanted en bloc. The mean cold ischemia time was 30.5 ::!:: 9.2 hours (range 4.7 to 57.!). The mean number of HLA matches and mismatches was 2.5 ::!:: 1.4 and 3.1 ::!:: 1.5, respectively. There were 17 (8.2%) 0 antigen mismatches. The mean follow-up was 15 ::!:: 17 months. The data were analyzed by intention-to-treat. The overall I-year actuarial patient survival was 94%; in the double therapy group, it was 93%, and in the triple therapy group, it was 96%. Overall I-year actuarial graft survival was 87%; in the double therapy group, it was 85%, and in the triple therapy group, it was 89%. When the patient and graft survival data were stratified to recipients under the age of 60 who did not have delayed graft function, the overall I-year actuarial patient survival was 97%, 95% in the double therapy group, and 98% in the triple therapy group. The corresponding l-year actuarial graft survival was 93%,92% in the double therapy group, and 93% in the triple therapy group. The mean serum creatinine was 1.6 ::!:: 0.8 mg/dL, 1.6 ::!:: 0.9 mg/dL in the double therapy group and 1.7 ::!:: 0.7 mg/dL in the triple therapy group. The mean tacrolimus dose was 8.7 ::!:: 6.6 mg/d; in the double therapy group it was 8.4 ::!:: 6.0 mg/d, and in the triple therapy group, it was 9.0 ::!:: 7.1 mg/d. The mean tacrolimus level was 10.1 ::!:: 4.4 ng/mL; in the double therapy group, it was 10.2 ::!:: 4.5 ng/mL, while in the triple therapy group, it was 10.1 ::!:: 4.2 ng/mL. The mean MMF dose in the patients taking MMF was 1142 ::!:: 493 mg/d. Thirty-six percent of the successfully transplanted patients were taken off prednisone. 34% in the double therapy