Effect of low-dose calcineurin inhibitors on acute rejection and graft survival

Indications:Acute graft rejection prophylaxis in 18 patients undergoing kidney transplantation. Patients:38 patients (sex not specified) were included in the study. 20/38 with a mean age of 29.8 years were given tacrolimus (group 1) while 18/38 with a mean age of 28.5 years were given Sandimmun (group 2). TypeofStudy:This is a retrospective clinical study which aims to assess the effects of low-dose Sandimmun or tacrolimus (FK-506) on early acute rejection (AR) rates and kidney graft survival. DosageDuration:Mean doses: 3.65 mg/kg daily, 3.33 mg/kg daily, 3.3 mg/kg daily and 2.76 mg/kg daily after 1, 3, 6 and 12 months, respectively. Mean follow-up: 14.8 months. ComparativeDrug:FK-506 (mean doses: 0.08 mg/kg daily, 0.075 mg/kg daily, 0.07 mg/kg daily and 0.08 mg/kg daily after 1, 3, 6 and 12 months, respectively). Mean follow-up: 9 months. Results:Delayed graft function rate was 10% (2/20) in group 1 and 16.7% (3/18) in group 2 (P=.8). Among those with delayed graft function, 1 patient in each group had a cadaver donor organ. The AR rate was 22% (4/20, 4/18) in each group respectively; 1 patient in group 1 had steroid resistant rejection. Mean creatinine level at the last follow-up was 1.32 ± 0.57 mg/dL in group 1 and 1.61 ± 0.51 mg/dL in group 2 (P=.12). No patient had graft loss during the follow-up period. There were no significant differences between the groups in the mean systolic and diastolic blood pressure (131 ± 18 mm Hg and 75 ± 13 mm Hg in group 1 and 127 ± 12 mm Hg and 79 ± 5 mm Hg in group 2), percentage of patients who required antihypertensive agents (77.8% (16/20), 72.2% (13/18), respectively, mean plasma total cholesterol (175.6 ± 33.8 mg/dL and 179.6 ± 37 mg/dL, respectively) and triglyceride levels (162.6 ± 81 mg/dL and 154 ± 63.2 mg/dL, respectively). Hypercholesterolemia and hypertriglyceridemia rates were also similar in the two groups (33.3% (7/20) and 16.7% (3/20) in group 1 and 33.3% (6/18) and 22.2 (4/18) in group 2 respectively). Hyperglycemia requiring insulin use, though reversible, was seen in 2 patients (10%) in group 1. AdverseEffects:Nephrotoxicity was observed in 1 patients, hypertension in an unspecified number of patients, hypercholesterolemia in 6 patients, and hypertriglyceridemia in 4 patients. FreeText:Concomitant medications include azathioprine, mycophenolate mofetil and steroids. The dosages and duration of these drugs were not stated. Antilymphocyte globulins were given as induction in cadaver cases and converted from 1 calcineurin inhibitor (CNI) to the other after more than 1 month post-transplantation were excluded from the AR rate and graft survival calculations. CNI drug doses and blood trough levels, AR rates, adverse effects of the CNIs, and graft survival were analyzed. Results were assessed in two groups according to the CNI received. P ≦. 05 was considered statistically significant. Tests: creatinine level, systolic and diastolic blood pressure, total cholesterol, triglycerides. Additional treatment: antihypertensive agents (n=13).