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Homocysteine lowering and cardiovascular events after acute myocardial infarction.
N Engl J Med. 2006 Apr 13; 354(15):1578-88.NEJM

Abstract

BACKGROUND

Homocysteine is a risk factor for cardiovascular disease. We evaluated the efficacy of homocysteine-lowering treatment with B vitamins for secondary prevention in patients who had had an acute myocardial infarction.

METHODS

The trial included 3749 men and women who had had an acute myocardial infarction within seven days before randomization. Patients were randomly assigned, in a two-by-two factorial design, to receive one of the following four daily treatments: 0.8 mg of folic acid, 0.4 mg of vitamin B12, and 40 mg of vitamin B6; 0.8 mg of folic acid and 0.4 mg of vitamin B12; 40 mg of vitamin B6; or placebo. The primary end point during a median follow-up of 40 months was a composite of recurrent myocardial infarction, stroke, and sudden death attributed to coronary artery disease.

RESULTS

The mean total homocysteine level was lowered by 27 percent among patients given folic acid plus vitamin B12, but such treatment had no significant effect on the primary end point (risk ratio, 1.08; 95 percent confidence interval, 0.93 to 1.25; P=0.31). Also, treatment with vitamin B6 was not associated with any significant benefit with regard to the primary end point (relative risk of the primary end point, 1.14; 95 percent confidence interval, 0.98 to 1.32; P=0.09). In the group given folic acid, vitamin B12, and vitamin B6, there was a trend toward an increased risk (relative risk, 1.22; 95 percent confidence interval, 1.00 to 1.50; P=0.05).

CONCLUSIONS

Treatment with B vitamins did not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. A harmful effect from combined B vitamin treatment was suggested. Such treatment should therefore not be recommended. (ClinicalTrials.gov number, NCT00266487.).

Authors+Show Affiliations

Institute of Community Medicine, University of Tromsø, Tromsø, Norway. kaare.bonaa@stolav.noNo affiliation info availableNo affiliation info availableNo 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

16531614

Citation

Bønaa, Kaare Harald, et al. "Homocysteine Lowering and Cardiovascular Events After Acute Myocardial Infarction." The New England Journal of Medicine, vol. 354, no. 15, 2006, pp. 1578-88.
Bønaa KH, Njølstad I, Ueland PM, et al. Homocysteine lowering and cardiovascular events after acute myocardial infarction. N Engl J Med. 2006;354(15):1578-88.
Bønaa, K. H., Njølstad, I., Ueland, P. M., Schirmer, H., Tverdal, A., Steigen, T., Wang, H., Nordrehaug, J. E., Arnesen, E., & Rasmussen, K. (2006). Homocysteine lowering and cardiovascular events after acute myocardial infarction. The New England Journal of Medicine, 354(15), 1578-88.
Bønaa KH, et al. Homocysteine Lowering and Cardiovascular Events After Acute Myocardial Infarction. N Engl J Med. 2006 Apr 13;354(15):1578-88. PubMed PMID: 16531614.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Homocysteine lowering and cardiovascular events after acute myocardial infarction. AU - Bønaa,Kaare Harald, AU - Njølstad,Inger, AU - Ueland,Per Magne, AU - Schirmer,Henrik, AU - Tverdal,Aage, AU - Steigen,Terje, AU - Wang,Harald, AU - Nordrehaug,Jan Erik, AU - Arnesen,Egil, AU - Rasmussen,Knut, AU - ,, Y1 - 2006/03/12/ PY - 2006/3/15/pubmed PY - 2006/4/19/medline PY - 2006/3/15/entrez SP - 1578 EP - 88 JF - The New England journal of medicine JO - N Engl J Med VL - 354 IS - 15 N2 - BACKGROUND: Homocysteine is a risk factor for cardiovascular disease. We evaluated the efficacy of homocysteine-lowering treatment with B vitamins for secondary prevention in patients who had had an acute myocardial infarction. METHODS: The trial included 3749 men and women who had had an acute myocardial infarction within seven days before randomization. Patients were randomly assigned, in a two-by-two factorial design, to receive one of the following four daily treatments: 0.8 mg of folic acid, 0.4 mg of vitamin B12, and 40 mg of vitamin B6; 0.8 mg of folic acid and 0.4 mg of vitamin B12; 40 mg of vitamin B6; or placebo. The primary end point during a median follow-up of 40 months was a composite of recurrent myocardial infarction, stroke, and sudden death attributed to coronary artery disease. RESULTS: The mean total homocysteine level was lowered by 27 percent among patients given folic acid plus vitamin B12, but such treatment had no significant effect on the primary end point (risk ratio, 1.08; 95 percent confidence interval, 0.93 to 1.25; P=0.31). Also, treatment with vitamin B6 was not associated with any significant benefit with regard to the primary end point (relative risk of the primary end point, 1.14; 95 percent confidence interval, 0.98 to 1.32; P=0.09). In the group given folic acid, vitamin B12, and vitamin B6, there was a trend toward an increased risk (relative risk, 1.22; 95 percent confidence interval, 1.00 to 1.50; P=0.05). CONCLUSIONS: Treatment with B vitamins did not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. A harmful effect from combined B vitamin treatment was suggested. Such treatment should therefore not be recommended. (ClinicalTrials.gov number, NCT00266487.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16531614/Homocysteine_lowering_and_cardiovascular_events_after_acute_myocardial_infarction_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa055227?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -