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

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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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