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Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial.
JAMA 2010; 303(24):2486-94JAMA

Abstract

CONTEXT

Blood homocysteine levels are positively associated with cardiovascular disease, but it is uncertain whether the association is causal.

OBJECTIVE

To assess the effects of reducing homocysteine levels with folic acid and vitamin B(12) on vascular and nonvascular outcomes.

DESIGN, SETTING, AND PATIENTS

Double-blind randomized controlled trial of 12,064 survivors of myocardial infarction in secondary care hospitals in the United Kingdom between 1998 and 2008.

INTERVENTIONS

2 mg folic acid plus 1 mg vitamin B(12) daily vs matching placebo.

MAIN OUTCOME MEASURES

First major vascular event, defined as major coronary event (coronary death, myocardial infarction, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization.

RESULTS

Allocation to the study vitamins reduced homocysteine by a mean of 3.8 micromol/L (28%). During 6.7 years of follow-up, major vascular events occurred in 1537 of 6033 participants (25.5%) allocated folic acid plus vitamin B(12) vs 1493 of 6031 participants (24.8%) allocated placebo (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.97-1.12; P = .28). There were no apparent effects on major coronary events (vitamins, 1229 [20.4%], vs placebo, 1185 [19.6%]; RR, 1.05; 95% CI, 0.97-1.13), stroke (vitamins, 269 [4.5%], vs placebo, 265 [4.4%]; RR, 1.02; 95% CI, 0.86-1.21), or noncoronary revascularizations (vitamins, 178 [3.0%], vs placebo, 152 [2.5%]; RR, 1.18; 95% CI, 0.95-1.46). Nor were there significant differences in the numbers of deaths attributed to vascular causes (vitamins, 578 [9.6%], vs placebo, 559 [9.3%]) or nonvascular causes (vitamins, 405 [6.7%], vs placebo, 392 [6.5%]) or in the incidence of any cancer (vitamins, 678 [11.2%], vs placebo, 639 [10.6%]).

CONCLUSION

Substantial long-term reductions in blood homocysteine levels with folic acid and vitamin B(12) supplementation did not have beneficial effects on vascular outcomes but were also not associated with adverse effects on cancer incidence.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN74348595.

Authors

No 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 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

20571015

Citation

Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group, et al. "Effects of Homocysteine-lowering With Folic Acid Plus Vitamin B12 Vs Placebo On Mortality and Major Morbidity in Myocardial Infarction Survivors: a Randomized Trial." JAMA, vol. 303, no. 24, 2010, pp. 2486-94.
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group, Armitage JM, Bowman L, et al. Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial. JAMA. 2010;303(24):2486-94.
Armitage, J. M., Bowman, L., Clarke, R. J., Wallendszus, K., Bulbulia, R., Rahimi, K., ... Collins, R. (2010). Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial. JAMA, 303(24), pp. 2486-94. doi:10.1001/jama.2010.840.
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) Collaborative Group, et al. Effects of Homocysteine-lowering With Folic Acid Plus Vitamin B12 Vs Placebo On Mortality and Major Morbidity in Myocardial Infarction Survivors: a Randomized Trial. JAMA. 2010 Jun 23;303(24):2486-94. PubMed PMID: 20571015.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial. AU - ,, AU - Armitage,Jane M, AU - Bowman,Louise, AU - Clarke,Robert J, AU - Wallendszus,Karl, AU - Bulbulia,Richard, AU - Rahimi,Kazem, AU - Haynes,Richard, AU - Parish,Sarah, AU - Sleight,Peter, AU - Peto,Richard, AU - Collins,Rory, PY - 2010/6/24/entrez PY - 2010/6/24/pubmed PY - 2010/6/29/medline SP - 2486 EP - 94 JF - JAMA JO - JAMA VL - 303 IS - 24 N2 - CONTEXT: Blood homocysteine levels are positively associated with cardiovascular disease, but it is uncertain whether the association is causal. OBJECTIVE: To assess the effects of reducing homocysteine levels with folic acid and vitamin B(12) on vascular and nonvascular outcomes. DESIGN, SETTING, AND PATIENTS: Double-blind randomized controlled trial of 12,064 survivors of myocardial infarction in secondary care hospitals in the United Kingdom between 1998 and 2008. INTERVENTIONS: 2 mg folic acid plus 1 mg vitamin B(12) daily vs matching placebo. MAIN OUTCOME MEASURES: First major vascular event, defined as major coronary event (coronary death, myocardial infarction, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization. RESULTS: Allocation to the study vitamins reduced homocysteine by a mean of 3.8 micromol/L (28%). During 6.7 years of follow-up, major vascular events occurred in 1537 of 6033 participants (25.5%) allocated folic acid plus vitamin B(12) vs 1493 of 6031 participants (24.8%) allocated placebo (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.97-1.12; P = .28). There were no apparent effects on major coronary events (vitamins, 1229 [20.4%], vs placebo, 1185 [19.6%]; RR, 1.05; 95% CI, 0.97-1.13), stroke (vitamins, 269 [4.5%], vs placebo, 265 [4.4%]; RR, 1.02; 95% CI, 0.86-1.21), or noncoronary revascularizations (vitamins, 178 [3.0%], vs placebo, 152 [2.5%]; RR, 1.18; 95% CI, 0.95-1.46). Nor were there significant differences in the numbers of deaths attributed to vascular causes (vitamins, 578 [9.6%], vs placebo, 559 [9.3%]) or nonvascular causes (vitamins, 405 [6.7%], vs placebo, 392 [6.5%]) or in the incidence of any cancer (vitamins, 678 [11.2%], vs placebo, 639 [10.6%]). CONCLUSION: Substantial long-term reductions in blood homocysteine levels with folic acid and vitamin B(12) supplementation did not have beneficial effects on vascular outcomes but were also not associated with adverse effects on cancer incidence. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN74348595. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/20571015/Effects_of_homocysteine_lowering_with_folic_acid_plus_vitamin_B12_vs_placebo_on_mortality_and_major_morbidity_in_myocardial_infarction_survivors:_a_randomized_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2010.840 DB - PRIME DP - Unbound Medicine ER -