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- Title
Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation.
- Authors
Chang-Kwon Oh; Kyu Ha Huh; Jong Soo Lee; Hong Rae Cho; Yu Seun Kim
- Abstract
Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materials and Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for 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 completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and 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 satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.
- Subjects
TACROLIMUS; DRUG efficacy; MEDICATION safety; RANDOMIZED controlled trials; KIDNEY transplantation; PATIENT satisfaction
- Publication
Yonsei Medical Journal, 2014, Vol 55, Issue 5, p1341
- ISSN
0513-5796
- Publication type
Article
- DOI
10.3349/ymj.2014.55.5.1341