Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , , , , , , , , , , , , , , , , |
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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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:34652022-06-02T12:27:25Repositório 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 |
|
_version_ |
1802764136115863552 |