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Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results Presented at the American Transplant Congress in Boston, MA, May 15-19, 2004 (abstracts 250461 and 251150).

dc.contributor.authorLevy, Garyen_US
dc.contributor.authorSchmidli, Heinzen_US
dc.contributor.authorPunch, Jeffery D.en_US
dc.contributor.authorTuttle-Newhall, Elizabethen_US
dc.contributor.authorMayer, Daviden_US
dc.contributor.authorNeuhaus, Peteren_US
dc.contributor.authorSamuel, Didieren_US
dc.contributor.authorNashan, Bjoernen_US
dc.contributor.authorKlempnauer, Juergenen_US
dc.contributor.authorLangnas, Alan N.en_US
dc.contributor.authorCalmus, Yvonen_US
dc.contributor.authorRogiers, Xavieren_US
dc.contributor.authorAbecassis, MIchael M.en_US
dc.contributor.authorFreeman, Richard B.en_US
dc.contributor.authorSloof, Maartenen_US
dc.contributor.authorRoberts, John P.en_US
dc.contributor.authorFischer, Lutzen_US
dc.date.accessioned2007-09-20T17:46:00Z
dc.date.available2008-01-03T16:20:24Zen_US
dc.date.issued2006-11en_US
dc.identifier.citationLevy, Gary; Schmidli, Heinz; Punch, Jeffrey; Tuttle-Newhall, Elizabeth; Mayer, David; Neuhaus, Peter; Samuel, Didier; Nashan, Bjorn; Klempnauer, Juergen; Langnas, Alan; Calmus, Yvon; Rogiers, Xavier; Abecassis, Michael; Freeman, Richard; Sloof, Maarten; Roberts, John; Fischer, Lutz (2006). "Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results Presented at the American Transplant Congress in Boston, MA, May 15-19, 2004 (abstracts 250461 and 251150). ." Liver Transplantation 12(11): 1640-1648. <http://hdl.handle.net/2027.42/55846>en_US
dc.identifier.issn1527-6465en_US
dc.identifier.issn1527-6473en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/55846
dc.identifier.urihttp://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16598777&dopt=citationen_US
dc.description.abstractEverolimus is a macrolide immunosuppressive agent with known consistent absorption. In this double-blind study, we examined the safety and tolerability of everolimus vs. placebo in de novo liver transplant recipients. One hundred and nineteen liver allograft recipients were randomized to 1 of 4 groups: everolimus 0.5 mg bid, everolimus 1.0 mg bid, everolimus 2 mg bid, or placebo. Patients received oral cyclosporine to achieve a target trough level of 150-400 ng/mL in combination with prednisone. Primary and secondary endpoints of safety, tolerability, and efficacy were determined at 12 months, and patients were followed through 36 months. There was a trend toward fewer treated acute rejections in the everolimus group than in the placebo group: everolimus 0.5 mg: 39.3%; everolimus 1.0 mg: 30.0%; everolimus 2 mg: 29.0%; placebo: 40.0% ( P = not significant). Adverse events were higher in everolimus-treated patients especially at the 4-mg/day dose, but there was no difference in the incidence of thrombocytopenia or leukopenia between all groups and renal function as determined by serum creatinine, and creatinine clearance remained stable to 36 months in everolimus-treated patients. Mean cholesterol and triglycerides increased from baseline in all treatment groups, and maximum levels were seen at 6 months. In conclusion, this study demonstrates that everolimus in combination with oral cyclosporine had an acceptable safety and tolerability profile, paving the way for additional studies in this transplant indication. Liver Transpl, 2006. © 2006 AASLD.en_US
dc.format.extent133002 bytes
dc.format.extent3118 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.publisherWiley Subscription Services, Inc., A Wiley Companyen_US
dc.subject.otherLife and Medical Sciencesen_US
dc.subject.otherSurgeryen_US
dc.titleSafety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results Presented at the American Transplant Congress in Boston, MA, May 15-19, 2004 (abstracts 250461 and 251150).en_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumUniversity of Michigan, Ann Arbor, MIen_US
dc.contributor.affiliationotherMultiorgan Transplantation, Toronto General Hospital, Toronto, Ontario, Canada ; Telephone: 1 416 340 5166; FAX: 1 416 340 3378 ; Multiorgan Transplantation, Toronto General Hospital, 585 University Ave., NCSB-11-1236, Toronto, Ontario, M5G 2N2 Canadaen_US
dc.contributor.affiliationotherNovartis Pharma AG, Basel, Switzerlanden_US
dc.contributor.affiliationotherDuke University Medical Center, Durham, NCen_US
dc.contributor.affiliationotherThe Queen Elisabeth Hospital, The Liver Unit, Birmingham, UKen_US
dc.contributor.affiliationotherUniversitaetsklinikum Rudolf Virchow, Chirurgische Klinik, Berlin, Germanyen_US
dc.contributor.affiliationotherHopital Paul Brousse, Villejulf, Franceen_US
dc.contributor.affiliationotherMedizinische Hochschule Hannover, Hannover, Germanyen_US
dc.contributor.affiliationotherMedizinische Hochschule Hannover, Hannover, Germanyen_US
dc.contributor.affiliationotherUniversity of Nebraska Medical Center, Omaha, NEen_US
dc.contributor.affiliationotherHopital Cochin, Paris, Franceen_US
dc.contributor.affiliationotherUniversity Krankenhaus Eppendorf, Hamburg, Germanyen_US
dc.contributor.affiliationotherNorthwestern University Medical Center, Chicago, ILen_US
dc.contributor.affiliationotherNew England Medical Center, Boston, MAen_US
dc.contributor.affiliationotherUniversity Hospital Gronigen, Gronigen, The Netherlandsen_US
dc.contributor.affiliationotherUniversity of California, San Francisco, CAen_US
dc.contributor.affiliationotherUniversity Krankenhaus Eppendorf, Hamburg, Germanyen_US
dc.identifier.pmid16598777en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/55846/1/20707_ftp.pdfen_US
dc.identifier.doihttp://dx.doi.org/10.1002/lt.20707en_US
dc.identifier.sourceLiver Transplantationen_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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