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Folic Acid Not Beneficial for Secondary Prevention
Elevated homocysteine levels are associated with adverse cardiovascular events, and folic-acid therapy reduces homocysteine levels. In this open-label, prospective trial from the Netherlands, researchers randomized 593 consecutive outpatients with coronary artery disease to folic acid (0.5 mg daily) or standard care. All had been taking statins for at least 3 months.
The 2 groups had similar baseline characteristics, including mean plasma homocysteine levels of 12 µmol/L. By 3 months, homocysteine levels had decreased among folic-acid recipients (by 18%) but not among controls. By a mean follow-up of 24 months, clinical vascular events (i.e., death, MI, stroke, invasive coronary procedures, vascular surgery) had occurred at similar rates in folic-acid (12.3%) and standard-care (11.2%) recipients; the similarity also was evident among patients in the highest quartile of baseline homocysteine level (>13.7 µmol/L). In multivariate analysis, poor creatinine clearance was a more important cardiovascular risk factor than elevated homocysteine level was.
Comment: In this study of CAD patients, folic acid was no better than standard care in preventing adverse cardiovascular events at 2 years. However, statin use in both groups may have masked any relative benefit of folic acid. Although the folic-acid dose was lower here than in some other studies, folic-acid recipients -- particularly those with the highest baseline homocysteine levels -- showed noteworthy homocysteine declines. Nonetheless, given the amount of homocysteine reduction observed, the study may have been underpowered to detect differences between groups in clinical events. Whether homocysteine is a marker or a causative factor in cardiac disease remains unresolved.
— Howard C. Herrmann, MD
Published in Journal Watch Cardiology August 8, 2003
Citation(s):
Liem A et al. Secondary prevention with folic acid: Effects on clinical outcomes. J Am Coll Cardiol 2003 Jun 18; 41:2105-13.
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