Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation.
10.3349/ymj.2017.58.1.217
- Author:
Su Hyung LEE
1
;
Jae Berm PARK
;
Chang Kwon OH
;
Myoung Soo KIM
;
Sung Joo KIM
;
Jongwon HA
Author Information
1. Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
- Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Enteric-coated mycophenolate sodium;
cyclosporine;
immunosuppression
- 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
- From:Yonsei Medical Journal
2017;58(1):217-225
- CountryRepublic of Korea
- Language:English
-
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.
