HOPE-2
(2006)Objective
To evaluate whether long-term therapy with folic acid and vitamins B6 and B12 reduces the risk of major cardiovascular events in high-risk patients.
Study Summary
• Despite significant reductions in homocysteine levels, there was no benefit in reducing major cardiovascular events.
• However, a significant reduction in stroke incidence was observed in the treatment group.
• However, a significant reduction in stroke incidence was observed in the treatment group.
Intervention
A total of 5,522 patients aged 55 years or older with pre-existing cardiovascular disease or diabetes and additional risk factors were randomized to receive daily supplementation with folic acid (2.5 mg), vitamin B6 (50 mg), and vitamin B12 (1 mg), or placebo. The average follow-up period was 5 years.
Study Design
Arms: Array
Outcome
The combination therapy significantly reduced homocysteine levels but did not lead to a reduction in the primary composite outcome of death from cardiovascular causes, myocardial infarction, or stroke. Notably, there was a significant reduction in the risk of stroke in the treatment group compared to placebo. No significant differences were observed in the rates of myocardial infarction or death from cardiovascular causes.