The Pharmaceutical Journal
Vol 276 No 7392 p312
18 March 2006

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Folic acid and B vitamins do not reduce CV events

Reducing elevated homocysteine levels with folic acid and B vitamins fails to reduce cardiovascular events, two studies reported at the American College of Cardiology annual scientific session in Atlanta, Georgia, show.

The second heart outcomes prevention evaluation (HOPE-2) trial studied 5,522 patients, 59 years of age or older, with a history of vascular disease (coronary, cerebrovascular, or peripheral arterial disease) or with diabetes plus at least one additional risk factor. They were given a combination tablet containing 2.5mg folic acid, 50mg vitamin B₆, and 1mg vitamin B₁₂ or placebo daily for an average of five years. Results showed no reduction in the primary end point of cardiovascular death, myocardial infarction and stroke (18.8 per cent with active treatment versus 19.8 per cent with placebo; P=0.41). The only endpoint showing benefit was a reduction in stroke, with an absolute risk reduction of 1.3 per cent (relative risk 0.75, 95 per cent confidence interval 0.59 to 0.97).

The data is also reported online in The New England Journal of Medicine (12 March).

Sotiris Antoniou, senior directorate pharmacist, cardiac services, at Barts and the London NHS Trust, said: “This study confirmed that there is no role for routine folate and vitamin B₆ and B₁₂ supplementation to reduce the risk of CV events in stable CV disease. This is in contrast to observational studies. However, an important point to note is that these results can only be applied to countries that have already implemented folate fortification, and indicates the need for further evaluation in non-folate fortifying areas.”

A second study included 3,749 patients who had had an MI in the seven days before being randomised to one of four daily regimens: 0.8mg folic acid; 0.4mg vitamin B₁₂; 40mg vitamin B₆; or placebo. The primary end point — a composite of recurrent MI, stroke and sudden death attributed to coronary artery disease — showed no difference between the different treatment options.