Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?

Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?

Context: High plasma homocysteine levels are a risk factor for mortality and vascular disease in observational studies of patients with chronic kidney disease. Folic acid and B vitamins decrease homocysteine levels in this population but whether they lower mortality is unknown. Objective: To determi...

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Autores principales: Salinas F,Manuel, Letelier S,Luz María
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2009
Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700018
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spelling oai:scielo:S0034-988720090007000182010-04-29Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?Salinas F,ManuelLetelier S,Luz MaríaContext: High plasma homocysteine levels are a risk factor for mortality and vascular disease in observational studies of patients with chronic kidney disease. Folic acid and B vitamins decrease homocysteine levels in this population but whether they lower mortality is unknown. Objective: To determine whether high doses of folic acid and B vitamins administered daily reduce mortality in patients with chronic kidney disease. Design, Setting and Participant: Double-blind randomized controlled trial (2001-2006) in 36 US Department of Veterans Affairs medical centers. Median follow-up was 3.2 years for 2056 participants aged 21 years or older with advanced chronic kidney disease (estimated creatinine clearance <30 ml/min) (n =1305) or end-stage renal disease (n =751) and high homocysteine levels (>15 micromol/L). Intervention: Participants received a daily capsule containing 40 mg off olic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo. Main outcome measures: The primary outcome was all-cause mortality. Secondary outcomes included myocardial infarction (MI), stroke, amputation of allow part of a lower extremity, a composite of these 3 plus all-cause mortality, time to initiation of dialysis, and time to thrombosis of arteriovenous access in hemodialysis patients. Results: Mean baseline homocysteine level was 24.0 micromol/L in the vitamin group and 24.2 micromol/L in the placebo group. It was lowered 6.3 micromol/L (25.8%; P < 001) in the vitamin group and 0.4 micromol/L (1.7%; P=.14) in the placebo group at 3 months, but there was no significant effect on mortality (448 vitamin group deaths vs. 436placebo group deaths) (hazard ratio [HR], 1.04; 95% CI, 0.91-1.18). No significant effects were demonstrated for secondary outcomes or adverse events: there were 129 Mis in the vitamin group vs. 150 for placebo (HR, 0.86; 95% CI, 0.67-1.08), 37 strokes in the vitamin group vs. 41 for placebo (HR, 0.90; 95% CI, 0.58-1.40), and 60 amputations in the vitamin group vs. 53 for placebo (HR, 1.14; 95% CI, 0.79-1.64). In addition, the composite of MI, stroke, and amputations plus mortality (P = .85), time to dialysis (P = . 38), and time to thrombosis in hemodialysis patients (P = .97) did not differ between the vitamin and placebo groups. Conclusion: Treatment with high doses of folic acid and B vitamins did not improve survival or reduce the incidence of vascular disease in patients with advanced chronic kidney disease or end-stage renal disease. Trial registration: clinical trials.gov Identifier: NCT00032435.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.137 n.7 20092009-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700018es10.4067/S0034-98872009000700018
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
description Context: High plasma homocysteine levels are a risk factor for mortality and vascular disease in observational studies of patients with chronic kidney disease. Folic acid and B vitamins decrease homocysteine levels in this population but whether they lower mortality is unknown. Objective: To determine whether high doses of folic acid and B vitamins administered daily reduce mortality in patients with chronic kidney disease. Design, Setting and Participant: Double-blind randomized controlled trial (2001-2006) in 36 US Department of Veterans Affairs medical centers. Median follow-up was 3.2 years for 2056 participants aged 21 years or older with advanced chronic kidney disease (estimated creatinine clearance <30 ml/min) (n =1305) or end-stage renal disease (n =751) and high homocysteine levels (>15 micromol/L). Intervention: Participants received a daily capsule containing 40 mg off olic acid, 100 mg of pyridoxine hydrochloride (vitamin B6), and 2 mg of cyanocobalamin (vitamin B12) or a placebo. Main outcome measures: The primary outcome was all-cause mortality. Secondary outcomes included myocardial infarction (MI), stroke, amputation of allow part of a lower extremity, a composite of these 3 plus all-cause mortality, time to initiation of dialysis, and time to thrombosis of arteriovenous access in hemodialysis patients. Results: Mean baseline homocysteine level was 24.0 micromol/L in the vitamin group and 24.2 micromol/L in the placebo group. It was lowered 6.3 micromol/L (25.8%; P < 001) in the vitamin group and 0.4 micromol/L (1.7%; P=.14) in the placebo group at 3 months, but there was no significant effect on mortality (448 vitamin group deaths vs. 436placebo group deaths) (hazard ratio [HR], 1.04; 95% CI, 0.91-1.18). No significant effects were demonstrated for secondary outcomes or adverse events: there were 129 Mis in the vitamin group vs. 150 for placebo (HR, 0.86; 95% CI, 0.67-1.08), 37 strokes in the vitamin group vs. 41 for placebo (HR, 0.90; 95% CI, 0.58-1.40), and 60 amputations in the vitamin group vs. 53 for placebo (HR, 1.14; 95% CI, 0.79-1.64). In addition, the composite of MI, stroke, and amputations plus mortality (P = .85), time to dialysis (P = . 38), and time to thrombosis in hemodialysis patients (P = .97) did not differ between the vitamin and placebo groups. Conclusion: Treatment with high doses of folic acid and B vitamins did not improve survival or reduce the incidence of vascular disease in patients with advanced chronic kidney disease or end-stage renal disease. Trial registration: clinical trials.gov Identifier: NCT00032435.
author Salinas F,Manuel
Letelier S,Luz María
spellingShingle Salinas F,Manuel
Letelier S,Luz María
Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
author_facet Salinas F,Manuel
Letelier S,Luz María
author_sort Salinas F,Manuel
title Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
title_short Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
title_full Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
title_fullStr Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
title_full_unstemmed Análisis crítico de un artículo: ¿Sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
title_sort análisis crítico de un artículo: ¿sirve reducir los niveles de homocisteinemia en los pacientes con insuficiencia renal avanzada?
publisher Sociedad Médica de Santiago
publishDate 2009
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009000700018
work_keys_str_mv AT salinasfmanuel analisiscriticodeunarticulosirvereducirlosnivelesdehomocisteinemiaenlospacientesconinsuficienciarenalavanzada
AT leteliersluzmaria analisiscriticodeunarticulosirvereducirlosnivelesdehomocisteinemiaenlospacientesconinsuficienciarenalavanzada
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