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Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial.
JAMA 2008; 299(17):2027-36JAMA

Abstract

CONTEXT

Recent randomized trials among patients with preexisting cardiovascular disease (CVD) have failed to support benefits of B-vitamin supplementation on cardiovascular risk. Observational data suggest benefits may be greater among women, yet women have been underrepresented in published randomized trials.

OBJECTIVE

To test whether a combination of folic acid, vitamin B6, and vitamin B12 lowers risk of CVD among high-risk women with and without CVD.

DESIGN, SETTING, AND PARTICIPANTS

Within an ongoing randomized trial of antioxidant vitamins, 5442 women who were US health professionals aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors, were enrolled in a randomized, double-blind, placebo-controlled trial to receive a combination pill containing folic acid, vitamin B6, and vitamin B12 or a matching placebo, and were treated for 7.3 years from April 1998 through July 2005.

INTERVENTION

Daily intake of a combination pill of 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12.

MAIN OUTCOME MEASURES

A composite outcome of myocardial infarction, stroke, coronary revascularization, or CVD mortality.

RESULTS

Compared with placebo, a total of 796 women experienced a confirmed CVD event (406 in the active group and 390 in the placebo group). Patients receiving active vitamin treatment had similar risk for the composite CVD primary end point (226.9/10,000 person-years vs 219.2/10,000 person-years for the active vs placebo group; relative risk [RR], 1.03; 95% confidence interval [CI], 0.90-1.19; P = .65), as well as for the secondary outcomes including myocardial infarction (34.5/10,000 person-years vs 39.5/10,000 person-years; RR, 0.87; 95% CI, 0.63-1.22; P = .42), stroke (41.9/10,000 person-years vs 36.8/10,000 person-years; RR, 1.14; 95% CI, 0.82-1.57; P = .44), and CVD mortality (50.3/10,000 person-years vs 49.6/10,000 person-years; RR, 1.01; 95% CI, 0.76-1.35; P = .93). In a blood substudy, geometric mean plasma homocysteine level was decreased by 18.5% (95% CI, 12.5%-24.1%; P < .001) in the active group (n = 150) over that observed in the placebo group (n = 150), for a difference of 2.27 micromol/L (95% CI, 1.54-2.96 micromol/L).

CONCLUSION

After 7.3 years of treatment and follow-up, a combination pill of folic acid, vitamin B6, and vitamin B12 did not reduce a combined end point of total cardiovascular events among high-risk women, despite significant homocysteine lowering.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00000541.

Authors+Show Affiliations

Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Ave E, Boston, Massachusetts 02215-1204, USA. calbert@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

18460663

Citation

Albert, Christine M., et al. "Effect of Folic Acid and B Vitamins On Risk of Cardiovascular Events and Total Mortality Among Women at High Risk for Cardiovascular Disease: a Randomized Trial." JAMA, vol. 299, no. 17, 2008, pp. 2027-36.
Albert CM, Cook NR, Gaziano JM, et al. Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial. JAMA. 2008;299(17):2027-36.
Albert, C. M., Cook, N. R., Gaziano, J. M., Zaharris, E., MacFadyen, J., Danielson, E., ... Manson, J. E. (2008). Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial. JAMA, 299(17), pp. 2027-36. doi:10.1001/jama.299.17.2027.
Albert CM, et al. Effect of Folic Acid and B Vitamins On Risk of Cardiovascular Events and Total Mortality Among Women at High Risk for Cardiovascular Disease: a Randomized Trial. JAMA. 2008 May 7;299(17):2027-36. PubMed PMID: 18460663.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial. AU - Albert,Christine M, AU - Cook,Nancy R, AU - Gaziano,J Michael, AU - Zaharris,Elaine, AU - MacFadyen,Jean, AU - Danielson,Eleanor, AU - Buring,Julie E, AU - Manson,JoAnn E, PY - 2008/5/8/pubmed PY - 2008/5/10/medline PY - 2008/5/8/entrez SP - 2027 EP - 36 JF - JAMA JO - JAMA VL - 299 IS - 17 N2 - CONTEXT: Recent randomized trials among patients with preexisting cardiovascular disease (CVD) have failed to support benefits of B-vitamin supplementation on cardiovascular risk. Observational data suggest benefits may be greater among women, yet women have been underrepresented in published randomized trials. OBJECTIVE: To test whether a combination of folic acid, vitamin B6, and vitamin B12 lowers risk of CVD among high-risk women with and without CVD. DESIGN, SETTING, AND PARTICIPANTS: Within an ongoing randomized trial of antioxidant vitamins, 5442 women who were US health professionals aged 42 years or older, with either a history of CVD or 3 or more coronary risk factors, were enrolled in a randomized, double-blind, placebo-controlled trial to receive a combination pill containing folic acid, vitamin B6, and vitamin B12 or a matching placebo, and were treated for 7.3 years from April 1998 through July 2005. INTERVENTION: Daily intake of a combination pill of 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12. MAIN OUTCOME MEASURES: A composite outcome of myocardial infarction, stroke, coronary revascularization, or CVD mortality. RESULTS: Compared with placebo, a total of 796 women experienced a confirmed CVD event (406 in the active group and 390 in the placebo group). Patients receiving active vitamin treatment had similar risk for the composite CVD primary end point (226.9/10,000 person-years vs 219.2/10,000 person-years for the active vs placebo group; relative risk [RR], 1.03; 95% confidence interval [CI], 0.90-1.19; P = .65), as well as for the secondary outcomes including myocardial infarction (34.5/10,000 person-years vs 39.5/10,000 person-years; RR, 0.87; 95% CI, 0.63-1.22; P = .42), stroke (41.9/10,000 person-years vs 36.8/10,000 person-years; RR, 1.14; 95% CI, 0.82-1.57; P = .44), and CVD mortality (50.3/10,000 person-years vs 49.6/10,000 person-years; RR, 1.01; 95% CI, 0.76-1.35; P = .93). In a blood substudy, geometric mean plasma homocysteine level was decreased by 18.5% (95% CI, 12.5%-24.1%; P < .001) in the active group (n = 150) over that observed in the placebo group (n = 150), for a difference of 2.27 micromol/L (95% CI, 1.54-2.96 micromol/L). CONCLUSION: After 7.3 years of treatment and follow-up, a combination pill of folic acid, vitamin B6, and vitamin B12 did not reduce a combined end point of total cardiovascular events among high-risk women, despite significant homocysteine lowering. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000541. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/18460663/Effect_of_folic_acid_and_B_vitamins_on_risk_of_cardiovascular_events_and_total_mortality_among_women_at_high_risk_for_cardiovascular_disease:_a_randomized_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.299.17.2027 DB - PRIME DP - Unbound Medicine ER -