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Mortality and cardiovascular events in patients treated with homocysteine-lowering B vitamins after coronary angiography: a randomized controlled trial.
JAMA 2008; 300(7):795-804JAMA

Abstract

CONTEXT

Observational studies have reported associations between circulating total homocysteine concentration and risk of cardiovascular disease. Oral administration of folic acid and vitamin B(12) can lower plasma total homocysteine levels.

OBJECTIVE

To assess the effect of treatment with folic acid and vitamin B(12) and the effect of treatment with vitamin B(6) as secondary prevention in patients with coronary artery disease or aortic valve stenosis.

DESIGN, SETTING, AND PARTICIPANTS

Randomized, double-blind controlled trial conducted in the 2 university hospitals in western Norway in 1999-2006. A total of 3096 adult participants undergoing coronary angiography (20.5% female; mean age, 61.7 years) were randomized. At baseline, 59.3% had double- or triple-vessel disease, 83.7% had stable angina pectoris, and 14.9% had acute coronary syndromes.

INTERVENTIONS

Using a 2 x 2 factorial design, participants were randomly assigned to 1 of 4 groups receiving daily oral treatment with folic acid, 0.8 mg, plus vitamin B(12), 0.4 mg, plus vitamin B(6), 40 mg (n = 772); folic acid plus vitamin B(12) (n = 772); vitamin B(6) alone (n = 772); or placebo (n = 780).

MAIN OUTCOME MEASURES

The primary end point was a composite of all-cause death, nonfatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and nonfatal thromboembolic stroke.

RESULTS

Mean plasma total homocysteine concentration was reduced by 30% after 1 year of treatment in the groups receiving folic acid and vitamin B(12). The trial was terminated early because of concern among participants due to preliminary results from a contemporaneous Norwegian trial suggesting adverse effects from the intervention. During a median 38 months of follow-up, the primary end point was experienced by a total of 422 participants (13.7%): 219 participants (14.2%) receiving folic acid/vitamin B(12) vs 203 (13.1%) not receiving such treatment (hazard ratio, 1.09; 95% confidence interval, 0.90-1.32; P = .36) and 200 participants (13.0%) receiving vitamin B(6) vs 222 (14.3%) not receiving vitamin B(6) (hazard ratio, 0.90; 95% confidence interval, 0.74-1.09; P = .28).

CONCLUSIONS

This trial did not find an effect of treatment with folic acid/vitamin B(12) or vitamin B(6) on total mortality or cardiovascular events. Our findings do not support the use of B vitamins as secondary prevention in patients with coronary artery disease.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00354081.

Authors+Show Affiliations

Department of Heart Disease, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, Norway. marta.ebbing@helse-bergen.noNo affiliation info availableNo 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
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18714059

Citation

Ebbing, Marta, et al. "Mortality and Cardiovascular Events in Patients Treated With Homocysteine-lowering B Vitamins After Coronary Angiography: a Randomized Controlled Trial." JAMA, vol. 300, no. 7, 2008, pp. 795-804.
Ebbing M, Bleie Ø, Ueland PM, et al. Mortality and cardiovascular events in patients treated with homocysteine-lowering B vitamins after coronary angiography: a randomized controlled trial. JAMA. 2008;300(7):795-804.
Ebbing, M., Bleie, Ø., Ueland, P. M., Nordrehaug, J. E., Nilsen, D. W., Vollset, S. E., ... Nygård, O. (2008). Mortality and cardiovascular events in patients treated with homocysteine-lowering B vitamins after coronary angiography: a randomized controlled trial. JAMA, 300(7), pp. 795-804. doi:10.1001/jama.300.7.795.
Ebbing M, et al. Mortality and Cardiovascular Events in Patients Treated With Homocysteine-lowering B Vitamins After Coronary Angiography: a Randomized Controlled Trial. JAMA. 2008 Aug 20;300(7):795-804. PubMed PMID: 18714059.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mortality and cardiovascular events in patients treated with homocysteine-lowering B vitamins after coronary angiography: a randomized controlled trial. AU - Ebbing,Marta, AU - Bleie,Øyvind, AU - Ueland,Per Magne, AU - Nordrehaug,Jan Erik, AU - Nilsen,Dennis W, AU - Vollset,Stein Emil, AU - Refsum,Helga, AU - Pedersen,Eva Kristine Ringdal, AU - Nygård,Ottar, PY - 2008/8/21/pubmed PY - 2008/8/30/medline PY - 2008/8/21/entrez SP - 795 EP - 804 JF - JAMA JO - JAMA VL - 300 IS - 7 N2 - CONTEXT: Observational studies have reported associations between circulating total homocysteine concentration and risk of cardiovascular disease. Oral administration of folic acid and vitamin B(12) can lower plasma total homocysteine levels. OBJECTIVE: To assess the effect of treatment with folic acid and vitamin B(12) and the effect of treatment with vitamin B(6) as secondary prevention in patients with coronary artery disease or aortic valve stenosis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind controlled trial conducted in the 2 university hospitals in western Norway in 1999-2006. A total of 3096 adult participants undergoing coronary angiography (20.5% female; mean age, 61.7 years) were randomized. At baseline, 59.3% had double- or triple-vessel disease, 83.7% had stable angina pectoris, and 14.9% had acute coronary syndromes. INTERVENTIONS: Using a 2 x 2 factorial design, participants were randomly assigned to 1 of 4 groups receiving daily oral treatment with folic acid, 0.8 mg, plus vitamin B(12), 0.4 mg, plus vitamin B(6), 40 mg (n = 772); folic acid plus vitamin B(12) (n = 772); vitamin B(6) alone (n = 772); or placebo (n = 780). MAIN OUTCOME MEASURES: The primary end point was a composite of all-cause death, nonfatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and nonfatal thromboembolic stroke. RESULTS: Mean plasma total homocysteine concentration was reduced by 30% after 1 year of treatment in the groups receiving folic acid and vitamin B(12). The trial was terminated early because of concern among participants due to preliminary results from a contemporaneous Norwegian trial suggesting adverse effects from the intervention. During a median 38 months of follow-up, the primary end point was experienced by a total of 422 participants (13.7%): 219 participants (14.2%) receiving folic acid/vitamin B(12) vs 203 (13.1%) not receiving such treatment (hazard ratio, 1.09; 95% confidence interval, 0.90-1.32; P = .36) and 200 participants (13.0%) receiving vitamin B(6) vs 222 (14.3%) not receiving vitamin B(6) (hazard ratio, 0.90; 95% confidence interval, 0.74-1.09; P = .28). CONCLUSIONS: This trial did not find an effect of treatment with folic acid/vitamin B(12) or vitamin B(6) on total mortality or cardiovascular events. Our findings do not support the use of B vitamins as secondary prevention in patients with coronary artery disease. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00354081. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/18714059/Mortality_and_cardiovascular_events_in_patients_treated_with_homocysteine_lowering_B_vitamins_after_coronary_angiography:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.300.7.795 DB - PRIME DP - Unbound Medicine ER -