Tolerability of enteric-coated mycophenolate sodium to 1 year in combination with cyclosporine and corticosteroids in renal transplant recipients.
Fiche publication
Date publication
novembre 2006
Auteurs
Membres identifiés du Cancéropôle Est :
Pr CHARPENTIER Bruno, Pr DUCLOUX Didier
Tous les auteurs :
Rostaing L, Mourad G, Kamar N, Garrigue V, Karras A, Lefrancois N, Charpentier B, Bourbigot B, Pouteil-Noble C, Bayle F, Lebranchu Y, Berthoux F, Le Meur Y, Kessler M, Moulin B, Ducloux D, Delahousse M, Lang P, Merville P, Chaouche-Teyara K, Legendre C
Lien Pubmed
Résumé
Enteric-coated mycophenolate sodium (EC-MPS) is therapeutically equivalent to mycophenolate mofetil, but delays release of mycophenolic acid until it reaches the small intestine. De novo renal transplant patients taking part in a 12-month, multicenter, randomized study received cyclosporine microemulsion (CsA-ME, early or delayed to day 6), EC-MPS, steroids, and interleukin-2 antagonist induction. Tolerability data relating to EC-MPS are reported. Ninety-seven patients were randomized to early CsA-ME and 100 patients to delayed CsA-ME. Median daily dose of EC-MPS was 1440 mg at all time points throughout the 12-month period. The most frequently reported adverse events were constipation, anemia, urinary tract infection, abdominal pain, leukopenia, and cytomegalovirus infection; there were four malignancies. Fifty patients (24.6%) discontinued EC-MPS prematurely by 12 months, including 42 patients (84%) who discontinued owing to adverse events. No patient discontinued treatment because of gastrointestinal adverse events. Two-thirds of patients (137 [67.5%]) maintained full EC-MPS dose throughout the 12-month study and did not require any dose reduction or dose interruption. EC-MPS is well tolerated in de novo renal transplant recipients when administered in combination with CsA-ME and steroids, with low rates of dose reductions or interruptions. Gastrointestinal adverse events were responsible for dose reduction or interruption in only 5% of patients.
Référence
Transplant Proc. 2006 Nov;38(9):2860-3.