No benefit on CV disease from vitamins in study of high-risk women
A combination of the antioxidant vitamins B6 and B12 and folic acid did not slow progression of cardiovascular (CV) disease in a randomized study of high-risk women, in whom major vascular events were as likely as in the women who did not take these vitamins. Dr. Christine M. Albert, Brigham and Women’s Hospital in Boston, USA, presented the results of the Women’s Antioxidant and Folic Acid Cardiovascular Study (WAFACS) study in the late-breaking clinical trials session at the Scientific Sessions of the American Heart Association.
Albert stated, “Our study does not suggest that taking folic acid, B6 or B12, primarily to prevent cardiovascular disease would be worthwhile. Women who are taking them solely for that purpose may want to discontinue.” She noted that no adverse effects were associated with these vitamins and that there are non-cardiac reasons for taking the vitamins.
WAFACS was a randomized placebo-controlled study of folic acid (2.5 mg daily), vitamin B6 (50 mg daily), and vitamin B12 (1 mg daily) compared to placebo, in a subset of 5,442 women who were already participating in the Women’s Antioxidant Cardiovascular Study (WACS), which has 8,171 women enrolled. A total of 2721 were randomized to active treatment and 2721 to placebo.
Study participants are health professionals over 40 years old, with either a defined history of CV disease or at least 3 risk factors, and were followed for 7.3 years. The study was administered by mail, with annual questionnaires to confirm compliance and events.
No between-group difference was seen for the composite primary endpoint (myocardial infarction (MI), stroke, revascularization, or CV death), nor for any of its components.
Event rate of the components of the primary endpoint
|
Vitamin Group
(number of events) |
Placebo Group
(number of events) |
P value |
Myocardial Infarction |
65 |
74 |
0.42 |
Stroke |
79 |
69 |
0.44 |
Revascularization |
253 |
255 |
0.87 |
CV death |
96 |
94 |
0.93 |
|
No benefit was seen in any of the pre-specified subgroups, including the high-risk primary prevention population. Albert stated that these data, along with the data from previously published randomized trials, do not support the use of folic acid and vitamin B supplements as preventive agents against CV disease in persons with established vascular disease or at high risk
|
