Adverse drug reaction driven immunosuppressive drug manipulations: a single-center comparison of enteric-coated mycophenolate sodium vs. mycophenolate mofetil


Karen Hardinger, PharmD, BCPS, Clinical Associate Professor of Pharmacy Practice, University of Missouri-Kansas City, Health Science Bldg, Rm 2241, 2464 Charlotte Street, Kansas City, MO 64108-2792, USA.
Tel.: 816 276 9023; fax: 816 276 4751;


Abstract:  Enteric-coated mycophenolate sodium (MPS) has been developed to help circumvent the upper gastrointestinal side-effects of mycophenolic acid by facilitating drug release in the small intestine. Many questions regarding the side-effect profile of MPS remain. Therefore, the purpose of this study is to review a single-center’s experience with mycophenolate mofetil (MMF) and MPS.

Methods:  This retrospective, sequential cohort analysis of de novo renal and pancreas transplants (n = 198) compared MMF 500 mg b.i.d. to MPS 360 mg b.i.d. in conjunction with antibody induction, tacrolimus, and steroids.

Results:  There were fewer adverse event driven drug manipulations in the MPS group at 90 d (4% MPS vs. 17% MMF) and 180 d (10% MPS vs. 24% MMF, p = 0.006, log-rank) after transplantation. There was a trend toward fewer GI-related hospital admissions in the MPS arm (7% MPS vs. 13% MMF, p = 0.18). Allograft outcomes including patient survival, graft survival, acute rejection, serum creatinine, and infection were similar.

Conclusion:  This single-center, sequential cohort study demonstrates that MPS is associated with fewer adverse event driven drug manipulations while maintaining similar safety and allograft outcomes.