title: Clinical outcomes of renal transplant recipients treated with enteric-coated mycophenolic acid vs. mycophenolate mofetil as a switch agent using a primary steroid-free rapamune and microemulsion cyclosporine protocol.
abstract: Since 2002 our transplant program has utilized a steroid free, cyclosporine (CSA)- and rapamycin (RAPA)-based maintenance immunosuppression regimen. In cases where it has been desirable to avoid the potential nephrotoxicity with this regimen we have used mycophenolic acid (MPA) as our "switch" drug of choice. Both mycophenolate mofetil (MMF) (Roche Inc., Nutley, NJ, USA) and enteric-coated MPA (ECM) (Novartis, East Hanover, NJ, USA) have been used. In this study, we retrospectively compared the tolerability of the two formulations of MPA. Thus we compared 103 recipients switched to RAPA/MMF (RMM group) to 114 switched to RAPA/ECM (REC group). There was a significantly higher incidence of patients requiring dose changes and drug discontinuation in the RMM group, as well as an increased frequency of dose changes. There were significantly more acute rejection episodes and kidney losses in the dose adjustment vs. no dose adjustment patients. However, when comparing the incidence of acute rejection and kidney loss between the RMM and REC groups, there was no significant difference. We conclude that in this cohort of recipients, the ECM formulation of MPA was better tolerated than the MMF formulation, resulting in fewer patients requiring dose adjustments or drug discontinuation.
authors.affiliation: Comprehensive Transplant Center, The Ohio State University Medical Center, Columbus, Ohio, USA. Ronald.pelletier@osumc.edu
authors.forename: R P
authors.initials: RP
authors.lastname: Pelletier
authors.forename: J
authors.initials: J
authors.lastname: Soule
authors.forename: M L
authors.initials: ML
authors.lastname: Henry
authors.forename: A
authors.initials: A
authors.lastname: Rajab
authors.forename: R M
authors.initials: RM
authors.lastname: Ferguson
mesh_terms: D016572:Cyclosporine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D012189:Retrospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus