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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
Design
randomised, 2 × 2 factorial design, placebo controlled trial (Norwegian Vitamin [NORVIT] trial).
Allocation
concealed.*
Blinding
blinded (clinicians, patients, data collectors, and outcome assessors).*
Follow up period
2.0–3.5 years (median 3.3 y).
Setting
35 hospitals in Norway.
Patients
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.
Intervention
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.
Outcomes
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.
Patient 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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