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Mizoribine Versus Mycophenolate Mofetil in Combination Therapy With Tacrolimus for De Novo Kidney Transplantation: Evaluation of Efficacy and Safety

Authors
 M.K. Ju  ;  K.H. Huh  ;  K.T. Park  ;  S.J. Kim  ;  B.H. Cho  ;  C.D. Kim  ;  B.J. So  ;  C.M. Kang  ;  S. Lee  ;  D.J. Joo  ;  Y.S. Kim 
Citation
 TRANSPLANTATION PROCEEDINGS, Vol.45(4) : 1481-1486, 2013 
Journal Title
 TRANSPLANTATION PROCEEDINGS 
ISSN
 0041-1345 
Issue Date
2013
MeSH
Adult ; Aged ; Drug Therapy, Combination ; Female ; Humans ; Immunosuppressive Agents/administration & dosage* ; Immunosuppressive Agents/adverse effects ; Kidney Transplantation* ; Male ; Middle Aged ; Mycophenolic Acid/administration & dosage ; Mycophenolic Acid/adverse effects ; Mycophenolic Acid/analogs & derivatives* ; Ribonucleosides/administration & dosage* ; Ribonucleosides/adverse effects ; Tacrolimus/administration & dosage* ; Tacrolimus/adverse effects ; Young Adult
Keywords
Adult ; Aged ; Drug Therapy, Combination ; Female ; Humans ; Immunosuppressive Agents/administration & dosage* ; Immunosuppressive Agents/adverse effects ; Kidney Transplantation* ; Male ; Middle Aged ; Mycophenolic Acid/administration & dosage ; Mycophenolic Acid/adverse effects ; Mycophenolic Acid/analogs & derivatives* ; Ribonucleosides/administration & dosage* ; Ribonucleosides/adverse effects ; Tacrolimus/administration & dosage* ; Tacrolimus/adverse effects ; Young Adult
Abstract
The present study compared the efficacy and safety of mizoribine (MZR) with mycophenolate mofetil (MMF) in kidney transplantation. This multicenter, randomized clinical trial. Employed doses of study drug tailored to the immunosuppressive need. The primary efficacy outcome was the incidence of biopsy-proven acute rejection episodes (BPAR). The safety of the study drug was assessed using the incidences of adverse events, drug discontinuations, and abnormal laboratory results. The 7 (6.4%) BPARs above grade II were observed in the MZR group noninferior to the 2 (1.8%) in the MMF group (95% confidence interval, -0.007-0.097 > noninferiority limit [-0.2]). BPAR was significantly decreased in the MZR group after the dose change (17/41 [41.4%] vs 8/69 [11.6%]; P < .0001) and the incidence of BPAR was similar between the MZR and MMF groups after the dose change (P = .592). The uric acid level was significantly elevated in the MZR group (P = .002). In conclusion, the efficacy and safety of MZR were similar and statistically noninferior to MMF in combination therapy with tacrolimus.
Full Text
http://www.sciencedirect.com/science/article/pii/S0041134513000857
DOI
10.1016/j.transproceed.2012.12.028
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yu Seun(김유선) ORCID logo https://orcid.org/0000-0002-5105-1567
Joo, Dong Jin(주동진) ORCID logo https://orcid.org/0000-0001-8405-1531
Joo, Man Ki(주만기) ORCID logo https://orcid.org/0000-0002-4112-7003
Huh, Kyu Ha(허규하) ORCID logo https://orcid.org/0000-0003-1364-6989
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/87021
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