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Article: Sirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: A randomized trial

TitleSirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: A randomized trial
Authors
KeywordsCalcineurin inhibitor
liver transplantation
maintenance therapy
nephrotoxicity
sirolimus
Issue Date2012
PublisherBlackwell Munksgaard. The Journal's web site is located at http://www.blackwellpublishing.com/journals/AJT
Citation
American Journal Of Transplantation, 2012, v. 12 n. 3, p. 694-705 How to Cite?
AbstractA large prospective, open-label, randomized trial evaluated conversion from calcineurin inhibitor (CNI)- to sirolimus (SRL)-based immunosuppression for preservation of renal function in liver transplantation patients. Eligible patients received liver allografts 6-144 months previously and maintenance immunosuppression with CNI (cyclosporine or tacrolimus) since early posttransplantation. In total, 607 patients were randomized (2:1) to abrupt conversion (<24 h) from CNI to SRL (n = 393) or CNI continuation for up to 6 years (n = 214). Between-group changes in baseline-adjusted mean Cockcroft-Gault GFR at month 12 (primary efficacy end point) were not significant. The primary safety end point, noninferiority of cumulative rate of graft loss or death at 12 months, was not met (6.6% vs. 5.6% in the SRL and CNI groups, respectively). Rates of death at 12 months were not significantly different, and no true graft losses (e.g. liver transplantation) were observed during the 12-month period. At 52 weeks, SRL conversion was associated with higher rates of biopsy-confirmed acute rejection (p = 0.02) and discontinuations (p < 0.001), primarily for adverse events. Adverse events were consistent with known safety profiles. In conclusion, liver transplantation patients showed no demonstrable benefit 1 year after conversion from CNI- to SRL-based immunosuppression. Conversion from calcineurin inhibitor to sirolimus-based immunosuppression for preservation of renal function in liver transplant recipients shows no demonstrable benefit at one year. See editorial by McKenna and Trotter on page 521. © copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.
Persistent Identifierhttp://hdl.handle.net/10722/145953
ISSN
2015 Impact Factor: 5.669
2015 SCImago Journal Rankings: 2.792
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorAbdelmalek, MFen_HK
dc.contributor.authorHumar, Aen_HK
dc.contributor.authorStickel, Fen_HK
dc.contributor.authorAndreone, Pen_HK
dc.contributor.authorPascher, Aen_HK
dc.contributor.authorBarroso, Een_HK
dc.contributor.authorNeff, GWen_HK
dc.contributor.authorRanjan, Den_HK
dc.contributor.authorToselli, LTen_HK
dc.contributor.authorGane, EJen_HK
dc.contributor.authorScarola, Jen_HK
dc.contributor.authorAlberts, RGen_HK
dc.contributor.authorMaller, ESen_HK
dc.contributor.authorLo, CMen_HK
dc.contributor.authorSirolimus Liver Conversion Trial Study Group-
dc.date.accessioned2012-03-27T09:03:56Z-
dc.date.available2012-03-27T09:03:56Z-
dc.date.issued2012en_HK
dc.identifier.citationAmerican Journal Of Transplantation, 2012, v. 12 n. 3, p. 694-705en_HK
dc.identifier.issn1600-6135en_HK
dc.identifier.urihttp://hdl.handle.net/10722/145953-
dc.description.abstractA large prospective, open-label, randomized trial evaluated conversion from calcineurin inhibitor (CNI)- to sirolimus (SRL)-based immunosuppression for preservation of renal function in liver transplantation patients. Eligible patients received liver allografts 6-144 months previously and maintenance immunosuppression with CNI (cyclosporine or tacrolimus) since early posttransplantation. In total, 607 patients were randomized (2:1) to abrupt conversion (<24 h) from CNI to SRL (n = 393) or CNI continuation for up to 6 years (n = 214). Between-group changes in baseline-adjusted mean Cockcroft-Gault GFR at month 12 (primary efficacy end point) were not significant. The primary safety end point, noninferiority of cumulative rate of graft loss or death at 12 months, was not met (6.6% vs. 5.6% in the SRL and CNI groups, respectively). Rates of death at 12 months were not significantly different, and no true graft losses (e.g. liver transplantation) were observed during the 12-month period. At 52 weeks, SRL conversion was associated with higher rates of biopsy-confirmed acute rejection (p = 0.02) and discontinuations (p < 0.001), primarily for adverse events. Adverse events were consistent with known safety profiles. In conclusion, liver transplantation patients showed no demonstrable benefit 1 year after conversion from CNI- to SRL-based immunosuppression. Conversion from calcineurin inhibitor to sirolimus-based immunosuppression for preservation of renal function in liver transplant recipients shows no demonstrable benefit at one year. See editorial by McKenna and Trotter on page 521. © copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.en_HK
dc.languageengen_US
dc.publisherBlackwell Munksgaard. The Journal's web site is located at http://www.blackwellpublishing.com/journals/AJTen_HK
dc.relation.ispartofAmerican Journal of Transplantationen_HK
dc.rightsThe definitive version is available at www.blackwell-synergy.com-
dc.subjectCalcineurin inhibitoren_HK
dc.subjectliver transplantationen_HK
dc.subjectmaintenance therapyen_HK
dc.subjectnephrotoxicityen_HK
dc.subjectsirolimusen_HK
dc.subject.meshCalcineurin - antagonists and inhibitors-
dc.subject.meshGraft Rejection - prevention and control-
dc.subject.meshGraft Survival - drug effects-
dc.subject.meshImmunosuppressive Agents - administration and dosage-
dc.subject.meshLiver Transplantation-
dc.titleSirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: A randomized trialen_HK
dc.typeArticleen_HK
dc.identifier.emailLo, CM: chungmlo@hkucc.hku.hken_HK
dc.identifier.authorityLo, CM=rp00412en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1111/j.1600-6143.2011.03919.xen_HK
dc.identifier.pmid22233522-
dc.identifier.scopuseid_2-s2.0-84857648997en_HK
dc.identifier.hkuros198964en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84857648997&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume12en_HK
dc.identifier.issue3en_HK
dc.identifier.spage694en_HK
dc.identifier.epage705en_HK
dc.identifier.isiWOS:000300832500026-
dc.publisher.placeDenmarken_HK
dc.identifier.scopusauthoridAbdelmalek, MF=6603512909en_HK
dc.identifier.scopusauthoridHumar, A=7006190496en_HK
dc.identifier.scopusauthoridStickel, F=7003813434en_HK
dc.identifier.scopusauthoridAndreone, P=23117559400en_HK
dc.identifier.scopusauthoridPascher, A=7004833746en_HK
dc.identifier.scopusauthoridBarroso, E=15029856000en_HK
dc.identifier.scopusauthoridNeff, GW=7005751521en_HK
dc.identifier.scopusauthoridRanjan, D=7006740172en_HK
dc.identifier.scopusauthoridToselli, LT=8592127000en_HK
dc.identifier.scopusauthoridGane, EJ=7003720102en_HK
dc.identifier.scopusauthoridScarola, J=54886365000en_HK
dc.identifier.scopusauthoridAlberts, RG=54886512500en_HK
dc.identifier.scopusauthoridMaller, ES=6602766786en_HK
dc.identifier.scopusauthoridLo, CM=7401771672en_HK

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