The Pharmaceutical Journal
Vol 280 No 7502 p590
17 May 2008

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Folic acid and vitamin B fail to reduce CV events in high-risk women

Folic acid combined with vitamin B supplementation does not reduce the risk of cardiovascular events in women at high risk of cardiovascular disease, researchers confirm. This is despite significant lowering of homocysteine levels (JAMA 2008;299:2027)

In the women’s antioxidant and folic acid cardiovascular study (WAFACS), part of an ongoing randomised study of antioxidant vitamins in women, researchers randomly assigned 5,442 women aged 42 years or older, with a history of CVD or three or more coronary risk factors, to receive either a combination pill containing 2.5mg folic acid, 50mg vitamin B₆ and 1mg vitamin B₁₂, or placebo.

During 7.3 years of follow-up, 406 women (14.9 per cent) in the active treatment group experienced at least one cardiovascular event included in the primary end point (myocardial infarction, stroke, coronary revascularisation or cardiovascular mortality) compared with 390 women (14.3 per cent) in the placebo group.

In a substudy of 300 patients, the researchers found that the geometric mean homocysteine level was 18.5 per cent lower in the active group than in the placebo group (95 per cent confidence interval, 12.5–24.1; P<0.001).

They comment: “Our results are consistent with prior randomised trials performed primarily among men with established vascular disease and do not support the use of folic acid and B vitamin supplements as preventive interventions for CVD in these high-risk fortified populations.”

The author of an editorial (ibid, p2086) concludes: “B vitamin supplements cannot currently be recommended for the prevention of CVD events (with the exception of rare genetic disorders) and there is no role for routine screening for elevated homocysteine levels.

“However, ongoing clinical research should provide further evidence on whether there may be any role for homocysteine-lowering B vitamin supplements in CVD prevention and for the overall importance of homocysteine as a CV risk factor.”