Novel Once-daily Extended-release Tacrolimus Versus Twice-daily Tacrolimus in De Novo Kidney Transplant Recipients During the Early Posttransplant Period

Abstract

Objective: Tacrolimus is used in more than 80\% of kidney transplant recipients due to its ability to avoid rejection. Irregularities in tacrolimus level may affect clinical outcomes by subjecting patients to adverse events associated with graft rejection or immunosuppressive therapy. There are two forms of tacrolimus

immediate-release (IR-T) and prolonged release (PR-T). This study is designed to compare the clinical follow-up of kidney transplant patients who are receiving prolonged-release (PR-T

Advagraf) and immediate-release (IR-T

Prograf) tacrolimus in the posttransplant first week. Methods: This study included 78 de novo, adult kidney transplant patients to prolonged-release tacrolimus 0.15 mg/kg/day (group 1, n=39) and immediate-release tacrolimus 0.15 mg/kg/day (group 2, n=39) for the first week in the posttransplant period. Demographic features, whole blood tacrolimus levels and kidney function were compared between the two groups. The presence of acute rejection and adverse events, antihypertensive drug use and arterial blood pressure of all patients were considered. Drug doses were determined according to the previously targeted tacrolimus level. SPSS 22 for Windows was used for statistical analysis. Results: Acute rejection was not seen in any patient and there were no adverse events in the posttransplant first week. However, group 2 patients were found to have higher tacrolimus levels on the posttransplant 1st, 4th and 7th days (p=0.02, p=0.009 and p=0.013 respectively). Serum creatinine levels were significantly increased in group 2 patients on the posttransplant 7th day (p=0.02). Systolic, diastolic or mean arterial blood pressure were not different between the groups. Conclusion: Prolonged-release tacrolimus is effective in preventing acute rejection when adequate blood levels are maintained, and appears promising as it makes it possible to avoid interindividual variation in absorption and early calcineurin inhibitor toxicity.