Use of Enteric-Coated Mycophenolate Sodium in De Novo Renal Transplant Recipients With High Incidence of Delayed Graft Function

• Published in: Transplantation proceedings Vol. 38; no. 3; pp. 905 - 908
• Main Authors: Schiavelli, R., Gaite, L., Agost Carren̈o, C., Baran, M., Novoa, P., Massari, P., Otero, A.B., Piulats, E.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Elsevier Inc 01.04.2006; Elsevier Science
• Subjects: Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Cyclosporine - administration & dosage; Cyclosporine - therapeutic use; Emulsions; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Graft Survival - drug effects; Humans; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - therapeutic use; Kidney Transplantation - immunology; Living Donors; Male; Medical sciences; Middle Aged; Mycophenolic Acid - administration & dosage; Mycophenolic Acid - therapeutic use; Pharmacology. Drug treatments; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Tablets, Enteric-Coated; Tissue, organ and graft immunology; High; Mycophenolic acid; Use; Transplantation; Homotransplantation; Epidemiology; De novo; Kidney; Delayed graft function; Incidence; Immunomodulator; Medicine; Antibiotic; Treatment; Urinary system; Sodium; Surgery; Antiviral; Graft; Immunosuppressive agent
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2006.02.047

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 ≥ 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 (C 2), enterio-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.