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Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.

Galan P, Kesse-Guyot E, Czernichow S, Briancon S, Blacher J, Hercberg S, SU.FOL.OM3 Collaborative Gro - BMJ (2010)

Bottom Line: Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)).Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.

View Article: PubMed Central - PubMed

Affiliation: UMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France. p.galan@uren.smbh.univ-paris13.fr

ABSTRACT

Objective: To investigate whether dietary supplementation with B vitamins or omega 3 fatty acids, or both, could prevent major cardiovascular events in patients with a history of ischaemic heart disease or stroke.

Design: Double blind, randomised, placebo controlled trial; factorial design.

Setting: Recruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians.

Participants: 2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke.

Intervention: Daily dietary supplement containing 5-methyltetrahydrofolate (560 μg), vitamin B-6 (3 mg), and vitamin B-12 (20 μg) or placebo; and containing omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) or placebo. Median duration of supplementation was 4.7 years.

Main outcome measures: Major cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease.

Results: Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)). Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).

Conclusion: This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.

Trial registration: Current Controlled Trials ISRCTN41926726.

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Related in: MedlinePlus

Fig 2 Effect of dietary supplementation with B vitamins on cardiovascular events and mortality (adjusted for age and sex)
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fig2: Fig 2 Effect of dietary supplementation with B vitamins on cardiovascular events and mortality (adjusted for age and sex)

Mentions: During a median of 4.7 years of follow-up, 157 participants (6.3%) experienced a major confirmed cardiovascular event, with 20 individuals experiencing more than one cardiovascular event. Allocation to B vitamins was not associated with any significant effect on major vascular events (75 v 82 individuals, hazard ratio 0.90 (95% confidence interval 0.66 to 1.23), P=0.50; fig 2). B vitamins had no significant effect on the cumulative incidence of the primary end points throughout the scheduled treatment period (fig 3).


Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.

Galan P, Kesse-Guyot E, Czernichow S, Briancon S, Blacher J, Hercberg S, SU.FOL.OM3 Collaborative Gro - BMJ (2010)

Fig 2 Effect of dietary supplementation with B vitamins on cardiovascular events and mortality (adjusted for age and sex)
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC2993045&req=5

fig2: Fig 2 Effect of dietary supplementation with B vitamins on cardiovascular events and mortality (adjusted for age and sex)
Mentions: During a median of 4.7 years of follow-up, 157 participants (6.3%) experienced a major confirmed cardiovascular event, with 20 individuals experiencing more than one cardiovascular event. Allocation to B vitamins was not associated with any significant effect on major vascular events (75 v 82 individuals, hazard ratio 0.90 (95% confidence interval 0.66 to 1.23), P=0.50; fig 2). B vitamins had no significant effect on the cumulative incidence of the primary end points throughout the scheduled treatment period (fig 3).

Bottom Line: Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)).Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.

View Article: PubMed Central - PubMed

Affiliation: UMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France. p.galan@uren.smbh.univ-paris13.fr

ABSTRACT

Objective: To investigate whether dietary supplementation with B vitamins or omega 3 fatty acids, or both, could prevent major cardiovascular events in patients with a history of ischaemic heart disease or stroke.

Design: Double blind, randomised, placebo controlled trial; factorial design.

Setting: Recruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians.

Participants: 2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke.

Intervention: Daily dietary supplement containing 5-methyltetrahydrofolate (560 μg), vitamin B-6 (3 mg), and vitamin B-12 (20 μg) or placebo; and containing omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) or placebo. Median duration of supplementation was 4.7 years.

Main outcome measures: Major cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease.

Results: Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)). Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).

Conclusion: This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.

Trial registration: Current Controlled Trials ISRCTN41926726.

Show MeSH
Related in: MedlinePlus