title: Conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in stable renal transplant patients: results of an Asia-Pacific study.
abstract: OBJECTIVE
  Mycophenolate mofetil has proven efficacy in the prophylaxis of acute rejection in solid organ transplantation; however, gastrointestinal intolerance can risk this efficacy because of associated dose adjustments and discontinued treatment. Enteric-coated mycophenolate sodium has demonstrated improved gastrointestinal tolerability, but the data in Asian subjects are scarce.
  
  
  METHODS
  This was a Phase-IIIb, open-label, single-arm, multicentre, prospective 6-month study which investigated safety and graft function in stable maintenance renal transplant recipients of Asian origin, after switching from mycophenolate mofetil to enteric-coated mycophenolate sodium at least 3 months after transplantation. Primary end-points included renal allograft function and safety parameters.
  
  
  RESULTS
  The study recruited patients from 16 centres in Asian countries. The intention-to-treat and safety populations both included 122 patients. Graft function remained stable over the course of the study as measured by creatinine clearance and glomerular filtration rate. At 6 months the incidence of any gastrointestinal adverse events was 20.5% (n = 25), none of which required dose adjustments. There were only three cases of biopsy proven acute rejection with no reports of graft loss or death.
  
  
  CONCLUSIONS
  This study demonstrated that enteric-coated mycophenolate sodium is a safe and effective alternative to mycophenolate mofetil in Asian kidney transplant recipients.
authors.affiliation: National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Po-Huang
authors.initials: PH
authors.lastname: Lee
authors.forename: Anantharaman
authors.initials: A
authors.lastname: Vathsala
authors.forename: Duck Jong
authors.initials: DJ
authors.lastname: Han
authors.forename: Tak-Mao
authors.initials: TM
authors.lastname: Chan
authors.forename: Hin-Seng
authors.initials: HS
authors.lastname: Wong
authors.forename: Chad
authors.initials: C
authors.lastname: Woodcock
authors.forename: Nicol
authors.initials: N
authors.lastname: Kurstjens
mesh_terms: D000328:Adult; D001208:Asia; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011446:Prospective Studies; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid