|
KMID : 1011320180100020054
|
|
Journal of Pharmacoepidemiology and Risk Management
2018 Volume.10 No. 2 p.54 ~ p.59
|
|
|
Comparative Analysis of Effectiveness and Safety between Mycophenolate Mofetil and Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
|
|
Jung Hye-Yoon
Kim Hyo-Jin
Kim Jae-Song
Kim Soo-Hyun
Son Eun-Sun
|
|
|
Abstract
|
|
|
Objective: Mycophenolate mofetil, a prodrug of mycophenolic acid, has been shown to be effective in the prevention of acute rejection in kidney transplantation. However, the use of mycophenolate mofetil may be limited by gastrointestinal adverse effects. The enteric-coated mycophenolate sodium is enteric-coated formulation of mycophenolic acid, developed to reduce gastrointestinal adverse effects. The object of this study was to compare the effectiveness and safety of enteric-coated mycophenolate sodium versus mycophenolate mofetil among kidney transplant recipients on tacrolimus-based immunosuppression.
Methods: Kidney transplant recipients from January 2015 to December 2015 were selected for this retrospective analysis. The immunosuppressive protocol consists of tacrolimus, mycophenolic acid, and prednisolone. Fifty-three kidney transplant recipients were classified into two groups enteric-coated mycophenolate sodium (n=13) versus mycophenolate mofetil (n=40). The primary endpoints were the incidence rate of acute rejection and gastrointestinal adverse effects during the first 12 months post-transplant. Secondary endpoints were the incidence rate of graft failure, neutropenia, infection and renal function within 12 months of follow-up.
Results: The incidence of acute rejection was 23.1% in the enteric-coated mycophenolate sodium group vs. 32.5% in the mycophenolate mofetil group (p=0.731). The incidence rate of graft failure and renal function was not significantly different between the enteric-coated mycophenolate sodium and mycophenolate mofetil patients. Gastrointestinal adverse effects occurred in 30.5% and 37.5% for enteric-coated mycophenolate sodium and mycophenolate mofetil, respectively (p=0.749). The neutropenia rate was 15.4% and 32.5% for enteric-coated mycophenolate sodium and mycophenolate mofetil (p=0.305).
Conclusion: Enteric-coated mycophenolate sodium, given in combination with tacrolimus and prednisolone, had a lower incidence of acute rejection, gastrointestinal adverse effects and neutropenia in kidney transplant recipients compared with mycophenolate mofetil. However, there was no significant differences.
|
|
|
KEYWORD
|
|
|
Kidney transplantation, Mycophenolic acid, Treatment outcome, Adverse effects
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|