Everolimus Plus Reduced-Exposure CsA versus Mycophenolic Acid Plus Standard-Exposure CsA in Renal-Transplant Recipients
dc.contributor.author | Silva, H. Tedesco Jr. | en_US |
dc.contributor.author | Cibrik, Diane M. | en_US |
dc.contributor.author | Johnston, T. | en_US |
dc.contributor.author | Lackova, E. | en_US |
dc.contributor.author | Mange, K. | en_US |
dc.contributor.author | Panis, C. | en_US |
dc.contributor.author | Walker, Rowan | en_US |
dc.contributor.author | Wang, Z. | en_US |
dc.contributor.author | Zibari, G. | en_US |
dc.contributor.author | Kim, Y. S. | en_US |
dc.date.accessioned | 2011-01-31T17:51:50Z | |
dc.date.available | 2011-08-02T18:19:14Z | en_US |
dc.date.issued | 2010-06 | en_US |
dc.identifier.citation | Silva, H. Tedesco Jr.; Cibrik, D.; Johnston, T.; Lackova, E.; Mange, K.; Panis, C.; Walker, R.; Wang, Z.; Zibari, G.; Kim, Y. S.; (2010). "Everolimus Plus Reduced-Exposure CsA versus Mycophenolic Acid Plus Standard-Exposure CsA in Renal-Transplant Recipients." American Journal of Transplantation 10(6): 1401-1413. <http://hdl.handle.net/2027.42/79307> | en_US |
dc.identifier.issn | 1600-6135 | en_US |
dc.identifier.issn | 1600-6143 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/79307 | |
dc.description.abstract | 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. | en_US |
dc.format.extent | 460218 bytes | |
dc.format.extent | 3106 bytes | |
dc.format.mimetype | application/pdf | |
dc.format.mimetype | text/plain | |
dc.publisher | Blackwell Publishing Inc | en_US |
dc.subject.other | Calcineurin Inhibitor Toxicity | en_US |
dc.subject.other | Cyclosporine | en_US |
dc.subject.other | Everolimus | en_US |
dc.subject.other | Renal Function | en_US |
dc.subject.other | Renal Transplantation | en_US |
dc.subject.other | Therapeutic Drug Monitoring | en_US |
dc.title | Everolimus Plus Reduced-Exposure CsA versus Mycophenolic Acid Plus Standard-Exposure CsA in Renal-Transplant Recipients | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Medicine (General) | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Department of Internal Medicine, University of Michigan, Ann Arbor, MI | en_US |
dc.contributor.affiliationother | Hospital do Rim e Hipertensão, São Paulo, Brazil | en_US |
dc.contributor.affiliationother | University of Kentucky, Lexington, KY | en_US |
dc.contributor.affiliationother | NSP F.D. Roosevelta, Banska Bystrica, Slovak Republic | en_US |
dc.contributor.affiliationother | Novartis Pharmaceuticals Corporation, East Hanover, NJ | en_US |
dc.contributor.affiliationother | The Royal Melbourne Hospital, Parkville, Victoria, Australia | en_US |
dc.contributor.affiliationother | Louisiana State Health Sciences Center, Shreveport, LA | en_US |
dc.contributor.affiliationother | Yonsei University College of Medicine Severance Hospital, Seoul, Korea | en_US |
dc.identifier.pmid | 20455882 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/79307/1/j.1600-6143.2010.03129.x.pdf | |
dc.identifier.doi | 10.1111/j.1600-6143.2010.03129.x | en_US |
dc.identifier.source | American Journal of Transplantation | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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