Patients With Coronary Artery Disease See No Gains In Treatment With Vitamin B Or Folic Acid

Though B vitamins have some health benefits, a study published in the
August 20 issue of JAMA finds that they are not an
effective means of preventing death or cardiovascular events in
patients with coronary artery disease.



To motivate this large randomized trial, researcher
Marta Ebbing, M.D. (Haukeland University Hospital, Bergen,
Norway) and colleagues reference previous studies that have found an
association between the risk of coronary artery disease and stroke and
the concentration of total homocysteine in blood. It is also known that
B-vitamin deficiencies can result in elevated total
homocysteine levels, and plasma total homocysteine levels can be
reduced if a person orally takes folic acid and vitamin B12. The
authors set out, "To evaluate the effects of homocysteine-lowering
treatment with folic acid plus vitamin B12 on mortality and
cardiovascular events."



The randomized controlled study consisted of 3,096 patients in
two Norwegian hospitals between 1999 and 2006. Randomization placed
patients in one of four groups that received a daily oral dose of:


0.8mg folic acid plus 0.4mg vitamin B12 plus 40mg
vitamin B6 - 772 patients,
0.8mg folic acid plus 0.4mg vitamin B12 - 772 patients,
40mg vitamin B6 - 772 patients,
Or placebo - 780 patients.

After one month, one year, and at the end of the study, patients were
to follow-up with the researchers by completing an interview, a
clinical examination, and a blood test. The primary end point (main
outcome measure) on which the researchers focused was a composite of
all-cause death, nonfatal acute myocardial infarction (heart attack),
acute hospitalization for unstable angina pectoris, and nonfatal
thromboembolic stroke.



It is important to note that this study was terminated prematurely.
Participants became concerned because preliminary results from another
Norwegian study suggested that there were no benefits from the
treatment and B vitamins were increasing the risk of cancer.



The authors did find, however, that, "Mean (average) plasma total
homocysteine concentration was reduced by 30 percent after 1 year of
treatment in the groups receiving folic acid and vitamin B12."
Additionally, "During a median (midpoint) 38 months of
follow-up, the primary end point was experienced by a total of 422
participants (13.7 percent): 219 participants (14.2 percent)
receiving folic acid/vitamin B12 vs. 203 (13.1 percent) not receiving
such treatment and 200 participants (13.0 percent) receiving vitamin B6
vs. 222 (14.3 percent) not receiving vitamin B6."



Concluding, the authors write that, "We could not detect any preventive
effect of intervention with folic acid plus vitamin B12 or with vitamin
B6 on mortality or major cardiovascular events among patients with
stable coronary artery disease undergoing intensive conventional
treatment. We found a numerically lower incidence of stroke and higher
incidence of cancer in the groups receiving folic acid, but these
observations were not statistically significant."



"Our findings do not support the use of B vitamins as secondary
prevention in patients with coronary artery disease."



Mortality and Cardiovascular Events in Patients Treated With
Homocysteine-Lowering B Vitamins After Coronary Angiography: A
Randomized Controlled Trial

Marta Ebbing; ??yvind Bleie; Per Magne Ueland; Jan Erik
Nordrehaug; Dennis W. Nilsen; Stein Emil Vollset; Helga Refsum; Eva
Kristine Ringdal Pedersen; Ottar Nyg??rd

JAMA(2008).
300[7]: pp. 795-804.

Click
Here to View Abstract



Written by: Peter M Crosta

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