Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial

Detalhes bibliográficos
Autor(a) principal: Bostom, Andrew G.
Data de Publicação: 2011
Outros Autores: Carpenter, Myra A., Kusek, John W., Levey, Andrew S., Hunsicker, Lawrence, Pfeffer, Marc A., Selhub, Jacob, Jacques, Paul F., Cole, Edward, Gravens-Mueller, Lisa, House, Andrew A., Kew, Clifton, McKenney, Joyce L., Pacheco-Silva, Alvaro [UNIFESP], Pesavento, Todd, Pirsch, John, Smith, Stephen, Solomon, Scott, Weir, Matthew, FAVORIT Study Investigators
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://repositorio.unifesp.br/handle/11600/33641
http://dx.doi.org/10.1161/CIRCULATIONAHA.110.000588
Resumo: Background-Kidney transplant recipients, like other patients with chronic kidney disease, experience excess risk of cardiovascular disease and elevated total homocysteine concentrations. Observational studies of patients with chronic kidney disease suggest increased homocysteine is a risk factor for cardiovascular disease. the impact of lowering total homocysteine levels in kidney transplant recipients is unknown.Methods and Results-In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing total homocysteine concentrations reduced the rate of the primary composite arteriosclerotic cardiovascular disease outcome (myocardial infarction, stroke, cardiovascular disease death, resuscitated sudden death, coronary artery or renal artery revascularization, lower-extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high-dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n=547 total events; hazards ratio [95% confidence interval]=0.99 [0.84 to 1.17]), secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86 to 1.26]), or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93 to 1.43]) compared to the low-dose multivitamin.Conclusions-Treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level.
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spelling Bostom, Andrew G.Carpenter, Myra A.Kusek, John W.Levey, Andrew S.Hunsicker, LawrencePfeffer, Marc A.Selhub, JacobJacques, Paul F.Cole, EdwardGravens-Mueller, LisaHouse, Andrew A.Kew, CliftonMcKenney, Joyce L.Pacheco-Silva, Alvaro [UNIFESP]Pesavento, ToddPirsch, JohnSmith, StephenSolomon, ScottWeir, MatthewFAVORIT Study InvestigatorsRhode Isl HospUniv N CarolinaNIDDKTufts Med CtrUniv IowaBrigham & Womens HospJean Mayer Human Nutr Res Ctr AgingUniv TorontoLondon Hlth Sci CtrUniv AlabamaUniversidade Federal de São Paulo (UNIFESP)Ohio State UnivUniv WisconsinDuke UnivUniv Maryland2016-01-24T14:06:25Z2016-01-24T14:06:25Z2011-04-26Circulation. Philadelphia: Lippincott Williams & Wilkins, v. 123, n. 16, p. 1763-1770, 2011.0009-7322http://repositorio.unifesp.br/handle/11600/33641http://dx.doi.org/10.1161/CIRCULATIONAHA.110.00058810.1161/CIRCULATIONAHA.110.000588WOS:000289833500013Background-Kidney transplant recipients, like other patients with chronic kidney disease, experience excess risk of cardiovascular disease and elevated total homocysteine concentrations. Observational studies of patients with chronic kidney disease suggest increased homocysteine is a risk factor for cardiovascular disease. the impact of lowering total homocysteine levels in kidney transplant recipients is unknown.Methods and Results-In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing total homocysteine concentrations reduced the rate of the primary composite arteriosclerotic cardiovascular disease outcome (myocardial infarction, stroke, cardiovascular disease death, resuscitated sudden death, coronary artery or renal artery revascularization, lower-extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high-dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n=547 total events; hazards ratio [95% confidence interval]=0.99 [0.84 to 1.17]), secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86 to 1.26]), or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93 to 1.43]) compared to the low-dose multivitamin.Conclusions-Treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level.National Institute of Diabetes and Digestive and Kidney DiseasesNational Institutes of HealthOffice of Dietary Supplements, National Institutes of HealthRhode Isl Hosp, Providence, RI 02903 USAUniv N Carolina, Dept Biostat, Chapel Hill, NC USANIDDK, Bethesda, MD USATufts Med Ctr, Boston, MA USAUniv Iowa, Iowa City, IA USABrigham & Womens Hosp, Boston, MA 02115 USAJean Mayer Human Nutr Res Ctr Aging, USDA, Boston, MA USAUniv Toronto, Toronto, ON, CanadaLondon Hlth Sci Ctr, London, ON, CanadaUniv Alabama, Birmingham, AL USAUniversidade Federal de São Paulo, São Paulo, BrazilOhio State Univ, Columbus, OH 43210 USAUniv Wisconsin, Madison, WI 53706 USADuke Univ, Durham, NC USAUniv Maryland, Baltimore, MD 21201 USAUniversidade Federal de São Paulo, EPM, São Paulo, BrazilNational Institute of Diabetes and Digestive and Kidney Diseases: U01 DK61700Web of Science1763-1770engLippincott Williams & WilkinsCirculationcardiovascular diseaserisk factorsmortalityclinical trialskidneykidney transplantationHomocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP11600/336412022-06-02 09:27:25.353metadata only accessoai:repositorio.unifesp.br:11600/33641Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652023-05-25T12:15:41.096791Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.en.fl_str_mv Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
title Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
spellingShingle Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
Bostom, Andrew G.
cardiovascular disease
risk factors
mortality
clinical trials
kidney
kidney transplantation
title_short Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
title_full Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
title_fullStr Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
title_full_unstemmed Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
title_sort Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
author Bostom, Andrew G.
author_facet Bostom, Andrew G.
Carpenter, Myra A.
Kusek, John W.
Levey, Andrew S.
Hunsicker, Lawrence
Pfeffer, Marc A.
Selhub, Jacob
Jacques, Paul F.
Cole, Edward
Gravens-Mueller, Lisa
House, Andrew A.
Kew, Clifton
McKenney, Joyce L.
Pacheco-Silva, Alvaro [UNIFESP]
Pesavento, Todd
Pirsch, John
Smith, Stephen
Solomon, Scott
Weir, Matthew
FAVORIT Study Investigators
author_role author
author2 Carpenter, Myra A.
Kusek, John W.
Levey, Andrew S.
Hunsicker, Lawrence
Pfeffer, Marc A.
Selhub, Jacob
Jacques, Paul F.
Cole, Edward
Gravens-Mueller, Lisa
House, Andrew A.
Kew, Clifton
McKenney, Joyce L.
Pacheco-Silva, Alvaro [UNIFESP]
Pesavento, Todd
Pirsch, John
Smith, Stephen
Solomon, Scott
Weir, Matthew
FAVORIT Study Investigators
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.institution.none.fl_str_mv Rhode Isl Hosp
Univ N Carolina
NIDDK
Tufts Med Ctr
Univ Iowa
Brigham & Womens Hosp
Jean Mayer Human Nutr Res Ctr Aging
Univ Toronto
London Hlth Sci Ctr
Univ Alabama
Universidade Federal de São Paulo (UNIFESP)
Ohio State Univ
Univ Wisconsin
Duke Univ
Univ Maryland
dc.contributor.author.fl_str_mv Bostom, Andrew G.
Carpenter, Myra A.
Kusek, John W.
Levey, Andrew S.
Hunsicker, Lawrence
Pfeffer, Marc A.
Selhub, Jacob
Jacques, Paul F.
Cole, Edward
Gravens-Mueller, Lisa
House, Andrew A.
Kew, Clifton
McKenney, Joyce L.
Pacheco-Silva, Alvaro [UNIFESP]
Pesavento, Todd
Pirsch, John
Smith, Stephen
Solomon, Scott
Weir, Matthew
FAVORIT Study Investigators
dc.subject.eng.fl_str_mv cardiovascular disease
risk factors
mortality
clinical trials
kidney
kidney transplantation
topic cardiovascular disease
risk factors
mortality
clinical trials
kidney
kidney transplantation
description Background-Kidney transplant recipients, like other patients with chronic kidney disease, experience excess risk of cardiovascular disease and elevated total homocysteine concentrations. Observational studies of patients with chronic kidney disease suggest increased homocysteine is a risk factor for cardiovascular disease. the impact of lowering total homocysteine levels in kidney transplant recipients is unknown.Methods and Results-In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing total homocysteine concentrations reduced the rate of the primary composite arteriosclerotic cardiovascular disease outcome (myocardial infarction, stroke, cardiovascular disease death, resuscitated sudden death, coronary artery or renal artery revascularization, lower-extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high-dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n=547 total events; hazards ratio [95% confidence interval]=0.99 [0.84 to 1.17]), secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86 to 1.26]), or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93 to 1.43]) compared to the low-dose multivitamin.Conclusions-Treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level.
publishDate 2011
dc.date.issued.fl_str_mv 2011-04-26
dc.date.accessioned.fl_str_mv 2016-01-24T14:06:25Z
dc.date.available.fl_str_mv 2016-01-24T14:06:25Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv Circulation. Philadelphia: Lippincott Williams & Wilkins, v. 123, n. 16, p. 1763-1770, 2011.
dc.identifier.uri.fl_str_mv http://repositorio.unifesp.br/handle/11600/33641
http://dx.doi.org/10.1161/CIRCULATIONAHA.110.000588
dc.identifier.issn.none.fl_str_mv 0009-7322
dc.identifier.doi.none.fl_str_mv 10.1161/CIRCULATIONAHA.110.000588
dc.identifier.wos.none.fl_str_mv WOS:000289833500013
identifier_str_mv Circulation. Philadelphia: Lippincott Williams & Wilkins, v. 123, n. 16, p. 1763-1770, 2011.
0009-7322
10.1161/CIRCULATIONAHA.110.000588
WOS:000289833500013
url http://repositorio.unifesp.br/handle/11600/33641
http://dx.doi.org/10.1161/CIRCULATIONAHA.110.000588
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.none.fl_str_mv Circulation
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 1763-1770
dc.publisher.none.fl_str_mv Lippincott Williams & Wilkins
publisher.none.fl_str_mv Lippincott Williams & Wilkins
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv
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