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Trial results sink homocysteine theory in CVD.(News)
ATLANTA -- The homocysteine hypothesis for secondary prevention of cardiovascular disease appears to be dead.
Reports in March from two large, separate intervention trials failed to show any benefit from supplements of folic acid and B vitamins in patients with proven vascular disease, even though the supplements cut serum levels of homocysteine by the goal of about 25%. "We achieved what we set out to do and have to conclude that supplements with folic acid and B vitamins do not reduce cardiovascular events in high-risk populations with established vascular disease," Dr. Eva M. Lonn said at the annual meeting of the American College of Cardiology.
The trial, led by Dr. Lonn of the Heart Outcomes Prevention Evaluation (HOPE) 2 study, involved more than 5,500 patients aged 55 or older with vascular disease or diabetes who were randomized to either a daily folic acid and B vitamin supplement or placebo. The results were presented at the meeting and were simultaneously released in a paper on the Internet (http://content.nejm.org/cgi/reprint/NEJMoa060900.pdf).
The second study, the Norwegian Vitamin (NORVIT) trial, randomized more than 3,700 patients soon after a myocardial infarction to a similar supplement or placebo. Results were first reported last September at the annual meeting of the European Society of Cardiology and were released online together with the HOPE 2 paper (http://content.nejm.org/cgi/reprint/NEJMoa055227.pdf).
Both studies were done to test a notion that had become entrenched based on findings from several retrospective and observational studies reported over the past 25 years. Those studies provided "ample support for the association of mild hyperhomocysteinemia with an elevated risk of atherothrombosis," wrote Dr. Joseph Loscalzo, chairman of the department of medicine at Brigham and Women's Hospital in Boston, in an editorial that accompanied the two reports (http://content.nejm.org/cgi/reprint/NEJMe068060.pdf).
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