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Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation

Authors
 Su Hyung Lee  ;  Jae Berm Park  ;  Chang-Kwon Oh  ;  Myoung Soo Kim  ;  Sung Joo Kim  ;  Jongwon Ha 
Citation
 YONSEI MEDICAL JOURNAL, Vol.58(1) : 217-225, 2017 
Journal Title
 YONSEI MEDICAL JOURNAL 
ISSN
 0513-5796 
Issue Date
2017
MeSH
Adult ; Aged ; Cyclosporine/administration & dosage* ; Female ; Graft Rejection/prevention & control* ; Humans ; Immunosuppressive Agents/administration & dosage* ; Incidence ; Kidney Transplantation ; Male ; Middle Aged ; Mycophenolic Acid/administration & dosage* ; Prospective Studies ; Tablets, Enteric-Coated ; Time Factors
Keywords
Enteric-coated mycophenolate sodium ; cyclosporine ; immunosuppression
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/1.73m² and 67.4 mL/min/1.73 m², 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.
Files in This Item:
T201700196.pdf Download
DOI
10.3349/ymj.2017.58.1.217
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Myoung Soo(김명수) ORCID logo https://orcid.org/0000-0002-8975-8381
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/154124
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