title: Use of enteric-coated mycophenolate sodium in de novo renal transplant recipients with high incidence of delayed graft function.
abstract: Patients with delayed graft function (DGF) are at risk of increased incidence for acute rejection episodes (ARE). Mycophenolate mofetil or induction therapy has produced a reduction in ARE incidence. An open, prospective, 3-month trial was performed in a group of Argentinian renal transplant recipients. We recruited 46 patients, 71.7% men, aged 41.7 +/- 13.8 years; including 36 (78.3%) recipients of cadaveric donors (CD) who were aged 43.4 +/- 15.5 years with a cold ischemia time of 19.4 hours +/- 5.4 minutes, and 10 (27.7%) recipients of living donors (LD) aged 37.8 +/- 12.9 years. HLA mismatches >or= 3 were observed in 58.4% of CD and in 7% of LD. All patients received two doses of basiliximab (20 mg each, days 0 and 4), cyclosporine microemulsion (CsA-ME) monitored by the second-hour concentrations (C2), enteric-coated mycophenolate sodium (EC-MPS; 720 mg twice a day, and steroids. A 58% incidence of DGF was observed. At the end of the third month the incidence of biopsy-proven ARE was 15%, with a median serum creatinine of was 1.54 +/- 0.42 mg/dL, including three grafts lost. Two patients died. No patient required EC-MPS dose discontinuation but 20% of patients required dose adjustments. The absence of discontinuations and the low incidence of dose adjustments of EC-MPS in this high-risk de novo population provided support of a suitable tolerability profile for this EC-MPS, and the possibility to impact efficacy results.
authors.affiliation: Hospital Argerich, Ciudad de Buenos Aires, Buenos Aires. rubenschiavelli@yahoo.com.ar
authors.forename: R
authors.initials: R
authors.lastname: Schiavelli
authors.forename: R
authors.initials: R
authors.lastname: Schlavelli
authors.forename: L
authors.initials: L
authors.lastname: Gaite
authors.forename: C
authors.initials: C
authors.lastname: Agost Carreno
authors.forename: M
authors.initials: M
authors.lastname: Baran
authors.forename: P
authors.initials: P
authors.lastname: Novoa
authors.forename: P
authors.initials: P
authors.lastname: Massari
authors.forename: A B
authors.initials: AB
authors.lastname: Otero
authors.forename: E
authors.initials: E
authors.lastname: Piulats
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use; D004655:Emulsions; D005260:Female; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D013608:Tablets, Enteric-Coated
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D016572:Cyclosporine; D009173:Mycophenolic Acid