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Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materialsand Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were convertedfrom tacrolimus twice daily to the same dose of extended-release tacrolimusonce daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfactionfor the two drugs at 6 months post-transplantation were compared. Results:Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completedthe study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigationaland control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfactionprofile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversionfrom twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.
