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- cardiovascular diseases
- diabetes mellitus
- folic acid
- hyperhomocysteinaemia
- vascular diseases
- vitamin B12
- vitamin B6
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
Design
randomised placebo controlled trial (Heart Outcomes Prevention Evaluation [HOPE] 2 trial).
Allocation
concealed.*
Blinding
blinded {clinicians, patients, data collectors, outcome assessors, and data analysts}†.*
Follow up period
mean 5 years.
Setting
145 centres in 13 countries (Canada, USA, Brazil, western Europe, and Slovakia).
Patients
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).
Intervention
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).
Outcomes
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.
Patient follow up
99% (intention to treat analysis). …
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