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Therapeutics
Lowering homocysteine with folic acid and B vitamins did not prevent vascular events in vascular disease

https://doi.org/10.1136/ebm.11.4.104

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    Lonn E, Yusuf S, Arnold MJ, et al. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med 2006;354:1567–77.
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 Q In patients with vascular disease, does lowering plasma homocysteine concentrations with folic acid and B vitamins reduce risk of major vascular events?

    Clinical impact ratings GP/FP/Primary care ★★★★★★☆ IM/Ambulatory care ★★★★★★☆ Neurology ★★★★★★☆ Cardiology ★★★★★★☆ Endocrine ★★★★★☆☆

    METHODS

    Embedded ImageDesign

    randomised placebo controlled trial (Heart Outcomes Prevention Evaluation [HOPE] 2 trial).

    Embedded ImageAllocation

    concealed.*

    Embedded ImageBlinding

    blinded {clinicians, patients, data collectors, outcome assessors, and data analysts}†.*

    Embedded ImageFollow up period

    mean 5 years.

    Embedded ImageSetting

    145 centres in 13 countries (Canada, USA, Brazil, western Europe, and Slovakia).

    Embedded ImagePatients

    5522 patients ⩾55 years of age (mean age 69 y, 72% men) with a history of coronary artery, cerebrovascular, or peripheral artery disease, or diabetes with ⩾1 risk factor for atherosclerosis. Exclusion criteria included planned revascularisation and other types of significant cardiovascular disease (CVD).

    Embedded ImageIntervention

    a combined pill with 2.5 mg folic acid, 50 mg vitamin B6, and 1 mg vitamin B12 taken once daily (n = 2758) or placebo (n = 2764).

    Embedded ImageOutcomes

    a composite end point of MI, stroke, or death from CV causes. Secondary outcomes included total ischaemic events (primary outcome components plus hospital admission for unstable angina or revascularisation), death from any cause, hospital admission for unstable angina, and revascularisation.

    Embedded ImagePatient follow up

    99% (intention to treat analysis). …

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    Footnotes

    • ↵* See glossary.

    • ↵† Information provided by author.

    • For correspondence: Dr E M Lonn, McMaster University, Hamilton, Ontario, Canada. lonnem{at}mcmaster.ca

    • Sources of funding: Canadian Institutes of Health Research. Study drugs provided by Jamieson Laboratories.

    Linked Articles

    • Glossary
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      BMJ Publishing Group Ltd
      BMJ Evidence-Based Medicine 2006; 11 127-127 Published Online First: 28 Jul 2006. doi: 10.1136/ebm.11.4.127-a