title: Evaluation of tolerability of enteric-coated mycophenolate sodium versus mycophenolate mofetil in de novo renal transplantation.
abstract: BACKGROUND
  Mycophenolate mofetil (MMF), pro-drug mycophenolic acid (MPA) is an immunosuppressive effective in the prophylaxis of acute rejection, but associated with gastrointestinal adverse events. Mycophenolate sodium (MPS) with enteric coating was developed with intention of reducing such gastrointestinal adverse events associated with MPA.
  
  
  OBJECTIVE
  To evaluate the tolerability of EC-MPS and MMF in renal transplant recipients.
  
  
  METHODS
  Retrospective, multicenter study, included 1380 patients who underwent a transplant between 07/01/2004 and 31/07/2007 in 18 Brazilian centers.Results1380 patients enrolled, 702 received EC-MPS and 678 received MMF. The average age of patients was 42.3 years, 60% were male and 62.5% of Caucasian ethnicity. The incidence of events evaluated in the composite endpoint of efficacy was not different between groups at the end of 24 months follow-up (22.9% for EC-MPS to MMF versus19.9%, p = 0.203). Patients treated with EC-MPS had a higher incidence of gastrointestinal adverse events compared to those treated with MMF (57.7%vs. 52.5%), but there was no statistical difference between groups. Viral infections were more frequent in the EC-MPS group (38.2%) compared with MMF (32.6%). There was no difference in mean tolerated dose after the first (1187 ± 344vs. 1209 ± 426 mg, p = 0.294) and second year (1172.3 ± 347 mgvs. 1197.4 ± 430.6 mg, p = 0.241) after transplantation.
  
  
  CONCLUSIONS
  There was no statistical difference in the incidence of acute rejection, delayed graft function and gastrointestinal events among treatments. The average tolerated dose of MPA was similar between groups; however, patients treated with MMF underwent more dose reductions and discontinuations of treatment.
authors.affiliation: Universidade Federal de São Paulo, BR.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Pacheco e Silva Filho
authors.affiliation: Universidade Federal de São Paulo, BR.
authors.forename: Roberto Ceratti
authors.initials: RC
authors.lastname: Manfro
authors.affiliation: Hospital Universitário Evangélico, BR.
authors.forename: Fabiana Loss de Carvalho
authors.initials: FL
authors.lastname: Contieri
authors.affiliation: Universidade Estadual de Campinas, BR.
authors.forename: Marilda
authors.initials: M
authors.lastname: Mazzali
authors.affiliation: Universidade de São Paulo, BR.
authors.forename: Valter Duro
authors.initials: VD
authors.lastname: Garcia
authors.affiliation: Universidade de São Paulo, BR.
authors.forename: Deise de Boni Monteiro de
authors.initials: Dde B
authors.lastname: Carvalho
authors.affiliation: University of Oxford, GB.
authors.forename: Saitovitch
authors.initials: S
authors.lastname: David
authors.affiliation: Universidade Federal de São Paulo, BR.
authors.forename: Paula
authors.initials: P
authors.lastname: Machado
authors.affiliation: Universidade Federal de São Paulo, BR.
authors.forename: Carolina Araujo
authors.initials: CA
authors.lastname: Rodrigues
mesh_terms: D000328:Adult; D004791:Enzyme Inhibitors / Q000009:adverse effects*; D005260:Female; D006801:Humans; D016030:Kidney Transplantation; D008297:Male; D009173:Mycophenolic Acid / Q000009:adverse effects*; D012189:Retrospective Studies; D013608:Tablets, Enteric-Coated
chemical_list: D004791:Enzyme Inhibitors; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid