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HOPE-2
Heart Outcomes Prevention Evaluation – 2
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Author(s) |
(a) HOPE-2 investigators
(b) HOPE-2 investigators
(c) Saposnik G, Ray JG, Sheridan P, McQueen M, Lonn E, and the HOPE 2 investigators
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Title(s) |
(a) Rationale, design and baseline characteristics of a large, simple, randomized trial of combined folic acid and vitamins B6 and B12 in high-risk patients: The Heart Outcomes Prevention Evaluation (HOPE)-2 trial
(b) Homocysteine lowering with folic acid and B vitamins in vascular disease
(c) Homocysteine-lowering therapy and stroke risk, severity, and disability. Additional findings from the HOPE 2 trial
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Reference(s) |
(a) Can J Cardiol 2006;22:47–53
(b) N Engl J Med 2006;354:1567–77
(c) Stroke 2009;40:1365–72
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Disease |
Cardiovascular disease
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Purpose |
To evaluate the effect of long-term folic acid plus vitamins B6 and B12 on risk of major cardiovascular events in high-risk patients
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Study design |
Randomised, double-blind, placebo-controlled |
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Follow-up |
Average 5 years
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Patients |
5522 patients (2758 folic acid plus B vitamins, 2764 placebo), mean age 69 years, with pre-existing cardiovascular disease or with diabetes mellitus and ≥ 1 additional risk factors
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Treatment regimen |
Folic acid, 2.5 mg, vitamin B6, 50 mg, and vitamin B12, 1 mg, in one combined pill/day, or placebo |
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Results |
Primary composite outcome of death from cardiovascular causes, MI and stroke occurred in 18.8% of patients receiving folic acid plus B vitamins and 19.8% of those receiving placebo (relative risk 0.95, 95% CI 0.84–1.07; p = 0.41). When each of the primary outcomes was analysed separately, no significant differences were found between the groups in either cardiovascular death or MI incidence. Stroke occurred in fewer patients in the folic acid plus B vitamins group than in the placebo group (4.0% vs 5.3%, relative risk 0.75, 95% CI 0.59–0.97; p = 0.03). Vitamin therapy reduced the risk of nonfatal stroke (absolute risk reduction 1.3%), but did not impact on neurological deficit at 24 h (p = 0.45) or functional dependence at discharge or day 7 (p = 0.62)
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Comments |
A secondary analysis of safety data from HOPE-2 concerning risk for venous thromboembolism has been published in Ann Intern Med 2007;146:761–7
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