Everolimus Plus Reduced‐Exposure CsA versus Mycophenolic Acid Plus Standard‐Exposure CsA in Renal‐Transplant Recipients
| Autor: | Diane M. Cibrik, K. Mange, Gazi B. Zibari, Rowan G. Walker, Z. Wang, C. Panis, Thomas D. Johnston, E. Lackova, H. Tedesco Silva, Yu Seun Kim |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Basiliximab Biopsy Recombinant Fusion Proteins Urology Renal function Kidney Kidney Function Tests Mycophenolic acid Adrenal Cortex Hormones Internal medicine medicine Humans Immunology and Allergy Pharmacology (medical) Everolimus Enzyme Inhibitors Antibacterial agent Sirolimus Transplantation Protein synthesis inhibitor business.industry Antibodies Monoclonal Middle Aged Mycophenolic Acid medicine.disease Kidney Transplantation Treatment Outcome Endocrinology Female Safety business Immunosuppressive Agents medicine.drug Kidney disease |
| Zdroj: | American Journal of Transplantation. 10:1401-1413 |
| ISSN: | 1600-6135 |
| Popis: | Everolimus allows calcineurin-inhibitor reduction without loss of efficacy and may improve renal-transplant outcomes. In a 24-month, open-label study, 833 de novo renal-transplant recipients were randomized to everolimus 1.5 or 3.0 mg/day (target troughs 3-8 and 6-12 ng/mL, respectively) with reduced-exposure CsA, or mycophenolic acid (MPA) 1.44 g/day plus standard-exposure CsA. Patients received basiliximab +/- corticosteroids. The primary endpoint was composite efficacy failure (treated biopsy-proven acute rejection, graft loss, death or loss to follow-up) and the main safety endpoint was renal function (estimated glomerular filtration rate [eGFR], by Modification of Diet in Renal Disease [MDRD]) at Month 12 (last-observation-carried-forward analyses). Month 12 efficacy failure rates were noninferior in the everolimus 1.5 mg (25.3%) and 3.0 mg (21.9%) versus MPA (24.2%) groups. Mean eGFR at Month 12 was noninferior in the everolimus groups versus the MPA group (54.6 and 51.3 vs 52.2 mL/min/1.73 m(2) in the everolimus 1.5 mg, 3.0 mg and MPA groups, respectively; 95% confidence intervals for everolimus 1.5 mg and 3.0 mg vs MPA: -1.7, 6.4 and -5.0, 3.2, respectively). The overall incidence of adverse events was comparable between groups. The use of everolimus with progressive reduction in CsA exposure, up to 60% at 1 year, resulted in similar efficacy and renal function compared with standard-exposure CsA plus MPA. |
| Databáze: | OpenAIRE |
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