title: Efficacy and safety of enteric-coated mycophenolate sodium (myfortic) in de novo renal transplant recipients: results of a 12-month multicenter, open-label, prospective study.
abstract: Enteric-coated mycophenolate sodium (EC-MPS) has been developed as an alternative formulation of mycophenolate acid aiming for improved gastrointestinal (GI) tolerability. This 12-month, open-label, multicenter, prospective study investigated the efficacy and tolerability of EC-MPS (720 mg twice a day) given in combination with cyclosporine microemulsion (CsA-ME) in de novo renal transplant recipients (n=140). The efficacy evaluation was the incidence of treatment failure (defined as biopsy-proven acute rejection [BPAR], graft loss, or death) after 6 and 12 months of treatment. The incidences of treatment failure, BPAR, and graft loss were comparable at 6 and 12 months (18.6% vs 22.1%, 15.7% vs 19.3%, and 1.4% vs 2.1%, respectively). Renal function at 6 and 12 months (creatinine clearance) was 60.6+/-19.8 mL/min and 63.2+/-27.1 mL/min, respectively. EC-MPS was generally well tolerated; 95.9% of the reported GI adverse events (AEs) were rated as mild or moderate. The rate of EC-MPS dose reduction was 26.4%; 4.3% were due to GI AEs. The rate of EC-MPS dose interruption was 10%; 2.1% were due to GI AEs. In summary, EC-MPS given in combination with CsA-ME demonstrates good efficacy and tolerability in de novo renal transplant recipients.
authors.affiliation: Division of Nephrology and Hypertension, Inselspital, University of Berne, Berne, Switzerland. bruno.vogt@chuv.ch
authors.forename: B
authors.initials: B
authors.lastname: Vogt
authors.forename: A
authors.initials: A
authors.lastname: Antoniadis
authors.forename: M
authors.initials: M
authors.lastname: Klinger
authors.forename: S
authors.initials: S
authors.lastname: Vitko
mesh_terms: D000328:Adult; D000368:Aged; D003404:Creatinine / Q000378:metabolism; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000276:immunology* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012449:Safety; D013608:Tablets, Enteric-Coated; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D003404:Creatinine; D009173:Mycophenolic Acid