Cited 86 times in
Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김유선 | - |
dc.date.accessioned | 2014-12-18T08:37:09Z | - |
dc.date.available | 2014-12-18T08:37:09Z | - |
dc.date.issued | 2013 | - |
dc.identifier.issn | 0041-1337 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/86643 | - |
dc.description.abstract | BACKGROUND: Strategies allowing calcineurin inhibitor minimization while maintaining efficacy may improve renal transplant outcomes. METHODS: A2309 was a 24-month, phase IIIb, open-label trial of 833 de novo renal transplant recipients randomized to everolimus, targeting trough concentrations of 3-8 or 6-12 ng/mL plus reduced-exposure cyclosporine A (CsA) or to mycophenolic acid (MPA) 1.44 g per day plus standard-exposure CsA. All patients received basiliximab ± corticosteroids. The incidence of the primary composite efficacy endpoint and its components (treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up), renal function (serum creatinine and estimated glomerular filtration rate), and adverse events (AEs) were compared at 24 months; as per the protocol, these analyses were not noninferiority. RESULTS: Composite efficacy failure rates (95% confidence interval for difference vs. MPA) were 32.9% (-2.2%, 13.0%), 26.9% (-7.9%, 6.8%), and 27.4% at month 24 in the everolimus 3-8 and 6-12 ng/mL and MPA groups, respectively. Mean estimated glomerular filtration rate (Modification of Diet in Renal Disease) at month 24 was 52.2 (-2.1, 5.5 mL/min/1.73 m(2)), 49.4 (-4.8, 2.7 mL/min/1.73 m(2)), and 50.5 mL/min/1.73 m(2), respectively. AEs were generally mild to moderate in severity and comparable between the groups. AEs leading to discontinuation were reported in 28.5% (P = 0.03 vs. MPA), 30.6% (P = 0.007 vs. MPA), and 20.5% of patients receiving everolimus 3-8 and 6-12 ng/mL and MPA, respectively. CONCLUSIONS: Everolimus trough concentrations targeted to 3-8 ng/mL, along with a greater than 60% reduction in CsA exposure, was associated with comparable efficacy and renal function versus MPA plus standard-exposure CsA over the 2-year period. A significantly higher incidence of AEs led to discontinuation in the everolimus groups compared with the MPA group. | - |
dc.description.statementOfResponsibility | open | - |
dc.relation.isPartOf | TRANSPLANTATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adrenal Cortex Hormones/therapeutic use | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Calcineurin Inhibitors* | - |
dc.subject.MESH | Cyclosporine/adverse effects | - |
dc.subject.MESH | Cyclosporine/blood | - |
dc.subject.MESH | Cyclosporine/therapeutic use* | - |
dc.subject.MESH | Drug Monitoring | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Everolimus | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glomerular Filtration Rate/drug effects | - |
dc.subject.MESH | Graft Rejection/immunology | - |
dc.subject.MESH | Graft Rejection/mortality | - |
dc.subject.MESH | Graft Rejection/physiopathology | - |
dc.subject.MESH | Graft Rejection/prevention & control* | - |
dc.subject.MESH | Graft Survival/drug effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunosuppressive Agents/adverse effects | - |
dc.subject.MESH | Immunosuppressive Agents/blood | - |
dc.subject.MESH | Immunosuppressive Agents/therapeutic use* | - |
dc.subject.MESH | Kaplan-Meier Estimate | - |
dc.subject.MESH | Kidney Transplantation/adverse effects | - |
dc.subject.MESH | Kidney Transplantation/immunology* | - |
dc.subject.MESH | Kidney Transplantation/mortality | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mycophenolic Acid/analogs & derivatives | - |
dc.subject.MESH | Mycophenolic Acid/therapeutic use | - |
dc.subject.MESH | Sirolimus/adverse effects | - |
dc.subject.MESH | Sirolimus/analogs & derivatives* | - |
dc.subject.MESH | Sirolimus/blood | - |
dc.subject.MESH | Sirolimus/therapeutic use | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학) | - |
dc.contributor.googleauthor | Diane Cibrik | - |
dc.contributor.googleauthor | Helio Tedesco Silva, Jr. | - |
dc.contributor.googleauthor | Anantharaman Vathsala | - |
dc.contributor.googleauthor | Eva Lackova | - |
dc.contributor.googleauthor | Catherine Cornu-Artis | - |
dc.contributor.googleauthor | Rowan G. Walker | - |
dc.contributor.googleauthor | Zailong Wang | - |
dc.contributor.googleauthor | Gazi B. Zibari | - |
dc.contributor.googleauthor | Fuad Shihab | - |
dc.contributor.googleauthor | Yu S. Kim | - |
dc.identifier.doi | 10.1097/TP.0b013e3182848e03 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A00785 | - |
dc.relation.journalcode | J02754 | - |
dc.identifier.eissn | 1534-6080 | - |
dc.identifier.pmid | 23422495 | - |
dc.identifier.url | http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&AN=00007890-201304150-00006&LSLINK=80&D=ovft | - |
dc.subject.keyword | Adrenal Cortex Hormones/therapeutic use | - |
dc.subject.keyword | Adult | - |
dc.subject.keyword | Calcineurin Inhibitors* | - |
dc.subject.keyword | Cyclosporine/adverse effects | - |
dc.subject.keyword | Cyclosporine/blood | - |
dc.subject.keyword | Cyclosporine/therapeutic use* | - |
dc.subject.keyword | Drug Monitoring | - |
dc.subject.keyword | Drug Therapy, Combination | - |
dc.subject.keyword | Everolimus | - |
dc.subject.keyword | Female | - |
dc.subject.keyword | Glomerular Filtration Rate/drug effects | - |
dc.subject.keyword | Graft Rejection/immunology | - |
dc.subject.keyword | Graft Rejection/mortality | - |
dc.subject.keyword | Graft Rejection/physiopathology | - |
dc.subject.keyword | Graft Rejection/prevention & control* | - |
dc.subject.keyword | Graft Survival/drug effects | - |
dc.subject.keyword | Humans | - |
dc.subject.keyword | Immunosuppressive Agents/adverse effects | - |
dc.subject.keyword | Immunosuppressive Agents/blood | - |
dc.subject.keyword | Immunosuppressive Agents/therapeutic use* | - |
dc.subject.keyword | Kaplan-Meier Estimate | - |
dc.subject.keyword | Kidney Transplantation/adverse effects | - |
dc.subject.keyword | Kidney Transplantation/immunology* | - |
dc.subject.keyword | Kidney Transplantation/mortality | - |
dc.subject.keyword | Male | - |
dc.subject.keyword | Middle Aged | - |
dc.subject.keyword | Mycophenolic Acid/analogs & derivatives | - |
dc.subject.keyword | Mycophenolic Acid/therapeutic use | - |
dc.subject.keyword | Sirolimus/adverse effects | - |
dc.subject.keyword | Sirolimus/analogs & derivatives* | - |
dc.subject.keyword | Sirolimus/blood | - |
dc.subject.keyword | Sirolimus/therapeutic use | - |
dc.subject.keyword | Time Factors | - |
dc.subject.keyword | Treatment Outcome | - |
dc.contributor.alternativeName | Kim, Yu Seun | - |
dc.contributor.affiliatedAuthor | Kim, Yu Seun | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 95 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 933 | - |
dc.citation.endPage | 942 | - |
dc.identifier.bibliographicCitation | TRANSPLANTATION, Vol.95(7) : 933-942, 2013 | - |
dc.identifier.rimsid | 29115 | - |
dc.type.rims | ART | - |
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