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Lowering homocysteine with folic acid and B vitamins did not prevent vascular events after myocardial infarction

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 Q In patients with acute myocardial infarction (MI), does lowering plasma homocysteine concentrations with folic acid plus vitamin B12 or vitamin B6 reduce risk of major vascular events?

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

METHODS

Embedded ImageDesign

randomised, 2 × 2 factorial design, placebo controlled trial (Norwegian Vitamin [NORVIT] trial).

Embedded ImageAllocation

concealed.*

Embedded ImageBlinding

blinded (clinicians, patients, data collectors, and outcome assessors).*

Embedded ImageFollow up period

2.0–3.5 years (median 3.3 y).

Embedded ImageSetting

35 hospitals in Norway.

Embedded ImagePatients

3749 patients 30–85 years of age (mean age 63 y, 74% men) with acute MI in the previous 7 days. Exclusion criteria included life expectancy <4 years.

Embedded ImageIntervention

a combined capsule with 0.8 mg folic acid, 40 mg vitamin B6, and 0.4 mg vitamin B12 (n = 937); 0.8 mg folic acid and 0.4 mg vitamin B12 (n = 935); 40 mg vitamin B6 (n = 934); or placebo (n = 943), taken once daily.

Embedded ImageOutcomes

a composite end point of MI, stroke, or sudden death from coronary heart disease. Secondary outcomes included MI, stroke, hospital admission for unstable angina, and death from any cause.

Embedded ImagePatient follow up

99% (intention to treat analysis).

MAIN RESULTS

Mean baseline homocysteine concentrations were 12.9–13.3 µmol/l (1.7–1.8 mg/l). Mean homocysteine concentration …

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