B Vitamins, Folic Acid Do Not Prevent Death or Cardiovascular Events

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Title: B Vitamins, Folic Acid Do Not Prevent Death or Cardiovascular Events
URL: http://www.pslgroup.com/dg/229846.htm
Doctor's Guide
August 20, 2008

CHICAGO -- August 20, 2008 -- In a large clinical trial involving patients with coronary artery disease, use of B vitamins was not effective for preventing death or cardiovascular events, according to a randomised study published in the August 20 issue of the Journal of the American Medical Association.

Marta Ebbing, MD, Haukeland University Hospital, Bergen, Norway, and colleagues evaluated the effects of homocysteine-lowering treatment with folic acid plus vitamin B₁₂ on mortality and cardiovascular events in 3,096 patients in 2 Norwegian hospitals between 1999 and 2006.

Patients were randomly assigned to receive 1 of 4 treatments daily: 0.8 mg folic acid plus 0.4 mg vitamin B₁₂ plus 40 mg vitamin B₆ (n = 772); folic acid plus vitamin B₁₂ (n = 772); vitamin B₆ alone (n = 772); or placebo (n = 780).

Patients were scheduled for follow-up visits with an interview, clinical examination, and blood sampling at 1 month, 1 year, and at a final study visit. The primary endpoint was a composite of all-cause death, nonfatal acute myocardial infarction, acute hospitalisation for unstable angina pectoris, and nonfatal thromboembolic stroke.

The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins.

Mean plasma total homocysteine concentration was reduced by 30% after 1 year of treatment in the groups receiving folic acid and vitamin B₁₂.

"During a median 38 months of follow-up, the primary endpoint was experienced by a total of 422 participants (13.7%): 219 participants (14.2%) receiving folic acid/vitamin B₁₂versus 203 (13.1%) not receiving such treatment and 200 participants (13.0%) receiving vitamin B₆ versus 222 (14.3%) not receiving vitamin B₆."

"… 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," the authors wrote.

"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."

SOURCE: American Medical Association

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