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In observational studies, homocysteine levels are associated with cardiovascular risk. However, randomized trials have not confirmed that homocysteine-lowering therapy (with folic acid and vitamins B6 and B12) reduces cardiovascular risk, perhaps because the trials were too short to evaluate this outcome. In addition, women have been underrepresented in these trials. To remedy these methodologic deficiencies, researchers conducted a 7-year, randomized, controlled trial that involved 5442 women (age, ≥40; mean age, 62) with known cardiovascular disease (CVD) or at least three major CVD risk factors.
Intervention subjects received folic acid (2.5 mg), vitamin B6 (50 mg), and vitamin B12 (1 mg) daily. During 7 years of follow-up, adverse CVD ev…