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B
Vitamin supplements do not appear to reduce
risk of CV events
Newswise — Women at high-risk of
cardiovascular disease who took a daily
supplement of folic acid and vitamin B6 and
B12 for seven years did not have an overall
reduced rate of cardiovascular events,
despite a significant lowering of
homocysteine levels, according to a study in
the May 7 issue of JAMA.
“Homocysteine [an amino acid produced by the
body] levels have been directly associated
with cardiovascular risk in observational
studies; and daily supplementation with
folic acid, vitamin B6, vitamin B12, or a
combination have been shown to reduce
homocysteine levels to varying degrees in
intervention studies,” the authors write.
Observational data suggest cardiovascular
benefits from B-vitamin supplementation may
be greater among women, yet women have been
underrepresented in published randomized
trials.
“Given the paucity of data on women and the
known influences of estrogen on homocysteine
levels, adequately powered randomized trials
of homocysteine lowering in women are still
needed.”
Christine M. Albert, M.D., M.P.H., of
Brigham and Women’s Hospital and Harvard
Medical School, Boston, and colleagues
tested whether a combination of folic acid,
vitamin B6 and vitamin B12 would reduce
total cardiovascular events among women at
high risk for the development of
cardiovascular disease (CVD) over 7 years of
follow-up.
Within an ongoing randomized trial of
antioxidant vitamins, 5,442 women who were
U.S. health professionals age 42 years or
older, with either a history of CVD or three
or more coronary risk factors, were enrolled
in a randomized trial to receive a
combination pill containing folic acid (2.5
mg), vitamin B6 (50 mg), and vitamin B12 (1
mg) or a matching placebo.
During the 7.3 years of follow-up, 796
participants (14.6 percent) experienced a
confirmed CVD event included in the primary
end point (heart attack, stroke, coronary
revascularization, or CVD death), with some
individuals experiencing more than one
event.
There was no difference in the cumulative
incidence of the primary combined end point
in the active vs. placebo treatment groups
at any time during study follow-up.
A total of 406 women (14.9 percent) in the
active treatment group and 390 (14.3
percent) in the placebo group experienced at
least one cardiovascular event included in
the primary end point.
When analyzed separately, there were no
significant differences for each of the
components of the primary outcome including
heart attack, stroke, and CVD death, between
the active treatment and placebo groups.
Also, the risk of death from any cause was
similar between the active and placebo
treatment groups.
The researchers also found that the average
plasma homocysteine level was 18.5 percent
lower in the active group than that observed
in the placebo group.
“Our results are consistent with prior
randomized 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 authors write.
Editor’s Note: Please see the article for
additional information, including other
authors, author contributions and
affiliations, financial disclosures, funding
and support, etc.
Editorial:
Homocysteine-Lowering B Vitamin Therapy in
Cardiovascular Prevention—Wrong Again?
In an accompanying editorial, Eva Lonn,
M.D., M.Sc., F.R.C.P.C., of McMaster
University, Hamilton, Ontario, Canada,
comments on the findings of Albert and
colleagues.
“… 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.”
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