Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantationopen accessCyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation
- Other Titles
- Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation
- Authors
- Lee, S.H.[Lee, S.H.]; Park, J.B.[Park, J.B.]; Oh, C.-K.[ Oh, C.-K.]; Kim, M.S.[ Kim, M.S.]; Kim, S.J.[Kim, S.J.]; Ha, J.[ Ha, J.]
- Issue Date
- Jan-2017
- Publisher
- YONSEI UNIV COLL MEDICINE
- Keywords
- Enteric-coated mycophenolate sodium; cyclosporine; immunosuppression
- Citation
- YONSEI MEDICAL JOURNAL, v.58, no.1, pp.217 - 225
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- YONSEI MEDICAL JOURNAL
- Volume
- 58
- Number
- 1
- Start Page
- 217
- End Page
- 225
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/30828
- DOI
- 10.3349/ymj.2017.58.1.217
- ISSN
- 0513-5796
- Abstract
- Purpose: The increased tolerability of enteric-coated mycophenolate sodium (EC-MPS), compared to mycophenolate mofetil, among kidney transplant recipients has the potential to facilitate cyclosporine (CsA) minimization. Therefore, a prospective trial to determine the optimum EC-MPS dose in CsA-based immunosuppression regimens is necessary. Materials and Methods: A comparative, parallel, randomized, open-label study was performed for 140 patients from four centers to compare the efficacy and tolerability of low dose CsA with standard dose EC-MPS (the investigational group) versus standard dose CsA with low dose EC-MPS (the control group) for six months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure [biopsy-confirmed acute rejection (BCAR), death, graft loss, loss to follow-up], and adverse events were compared. Results: The mean estimated glomerular filtration rate (eGFR) of the investigational group at six months post-transplantation was non-inferior to that of the control group (confidence interval between 57.3 mL/min/1.73m(2) and 67.4 mL/min/1.73 m(2), p<0.001). One graft loss was reported in the control group, and no patient deaths were reported in either group. The incidence of BCAR of the investigational group was 8.7%, compared to 18.8% in the control group (p=0.137), during the study period. There were no significant differences (p>0.05) in the incidence of discontinuations and serious adverse events (SAE) between the groups. Conclusion: CsA minimization using a standard dose of EC-MPS kept the incidence of acute rejection and additional risks as low as conventional immunosuppression and provided therapeutic equivalence in terms of renal graft function and safety issues.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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