Background Homocysteine is a risk factor for cardiovasculardisease. We evaluated the efficacy of homocysteine-loweringtreatment with B vitamins for secondary prevention in patientswho had had an acute myocardial infarction.
Methods The trial included 3749 men and women who had had anacute 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 mgof 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 vitaminB6; or placebo. The primary end point during a median follow-upof 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 27percent among patients given folic acid plus vitamin B12, butsuch treatment had no significant effect on the primary endpoint (risk ratio, 1.08; 95 percent confidence interval, 0.93to 1.25; P=0.31). Also, treatment with vitamin B6 was not associatedwith any significant benefit with regard to the primary endpoint (relative risk of the primary end point, 1.14; 95 percentconfidence interval, 0.98 to 1.32; P=0.09). In the group givenfolic acid, vitamin B12, and vitamin B6, there was a trend towardan increased risk (relative risk, 1.22; 95 percent confidenceinterval, 1.00 to 1.50; P=0.05).
Conclusions Treatment with B vitamins did not lower the riskof 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.govnumber, NCT00266487
[ClinicalTrials.gov]
.)
Source Information
From the Institute of Community Medicine, University of Tromsø, Tromsø (K.H.B., I.N., H.S., E.A.); the Locus for Homocysteine and Related Vitamins and the Section for Pharmacology, Institute of Medicine, University of Bergen, Bergen (P.M.U.); the Norwegian Institute of Public Health, Oslo (A.T.); the Department of Heart Disease, University Hospital of Northern Norway, Tromsø (T.S., H.W., K.R.); and the Department of Heart Disease, Haukeland University Hospital, Bergen (J.E.N.) — all in Norway. This article was published at www.nejm.org on March 12, 2006.
Address reprint requests to Dr. Bønaa at the Institute of Community Medicine, University of Tromsø, N-9037 Tromsø, Norway, or at kaare.bonaa{at}stolav.no.
Homocysteine, B Vitamins, and Cardiovascular Disease
de Craen A. J.M., Stott D. J., Westendorp R. G.J., Khare A., Lopez M., Gogtay J., Quinlivan E. P., Gregory J. F. III, Refsum H., Smith A. D., Wang X., Demirtas H., Xu X., Tomlinson D. R., Lang D., Lewis M. J., Lonn E., the HOPE-2 Investigators , Bønaa K. H., Tverdal A., Ueland P. M.
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N Engl J Med 2006;
355:205-211, Jul 13, 2006.
Correspondence
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