Tolerability of enteric-coated mycophenolate sodium to 1 year in combination with cyclosporine and corticosteroids in renal transplant recipients

Autor: Georges Mourad, Pierre Merville, Lionel Rostaing, Yvon Lebranchu, Peter Lang, Nassim Kamar, Didier Ducloux, François Bayle, M. Kessler, B. Moulin, Michel Delahousse, Valérie Garrigue, Nicole Lefrançois, Bernard Bourbigot, Claire Pouteil-Noble, C. Legendre, Y. Le Meur, Alexandre Karras, François Berthoux, Bernard Charpentier, Kamel Chaouche-Teyara
Přispěvatelé: Service de Néphrologie - Hypertension Artérielle Dialyse - Transplantation, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Legendre for The French Myriade FR01 Study Group, Saas, Philippe, Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)
Jazyk: angličtina
Rok vydání: 2006
Předmět:
Male
MESH: Emulsions
MESH: Tissue Donors
030232 urology & nephrology
030230 surgery
Mycophenolate
Gastroenterology
MESH: Cyclosporine
MESH: Kidney Transplantation
0302 clinical medicine
Adrenal Cortex Hormones
Isoantibodies
Leukopenia
MESH: Middle Aged
Histocompatibility Testing
Drug Tolerance
Middle Aged
Tissue Donors
3. Good health
Tolerability
Cyclosporine
[SDV.IMM]Life Sciences [q-bio]/Immunology
Drug Therapy
Combination
Emulsions
Female
Kidney Diseases
Tablets
Enteric-Coated
medicine.symptom
medicine.drug
Adult
medicine.medical_specialty
[SDV.IMM] Life Sciences [q-bio]/Immunology
Urinary system
MESH: Drug Tolerance
MESH: Tablets
Enteric-Coated
MESH: Histocompatibility Testing
Mycophenolic acid
MESH: Adrenal Cortex Hormones
03 medical and health sciences
Internal medicine
medicine
Humans
Adverse effect
MESH: Mycophenolic Acid
Transplantation
MESH: Kidney Diseases
MESH: Humans
business.industry
MESH: Adult
Mycophenolic Acid
Ciclosporin
Kidney Transplantation
MESH: Male
MESH: Isoantibodies
Surgery
MESH: Drug Therapy
Combination
business
MESH: Female
Zdroj: Transplantation Proceedings
Transplantation Proceedings, Elsevier, 2006, 38 (9), pp.2860-3. ⟨10.1016/j.transproceed.2006.08.119⟩
ISSN: 0041-1345
DOI: 10.1016/j.transproceed.2006.08.119⟩
Popis: International audience; 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.
Databáze: OpenAIRE
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