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Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial.
Blood 2007; 109(1):139-44Blood

Abstract

The Vitamins and Thrombosis (VITRO) study investigated the effect of homocysteine lowering by daily supplementation of B vitamins on the risk reduction of deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients between 20 to 80 years old with a first objectively confirmed proximal DVT or PE in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent was obtained, patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine, and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End points were objectively diagnosed recurrent DVT or PE. A total of 701 patients were enrolled (360 in the hyperhomocysteinemic and 341 in the normohomocysteinemic group). The number of recurrent events of venous thrombosis was 43 of 353 in the vitamin group (54/1000 py) and 50 of 348 in the placebo group (64/1000 py). The hazard ratio associated with vitamin treatment was 0.84 (95% CI, 0.56-1.26): 1.14 (95% CI, 0.65-1.98) in the hyperhomocysteinemic group and 0.58 (95% CI, 0.31-1.07) in the normohomocysteinemic group. The results of our study do not show that homocysteine lowering by B vitamin supplementation prevents recurrent venous thrombosis.

Authors+Show Affiliations

Department of Endocrinology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, The Netherlands. m.denheijer@endo.umcn.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16960155

Citation

den Heijer, Martin, et al. "Homocysteine Lowering By B Vitamins and the Secondary Prevention of Deep Vein Thrombosis and Pulmonary Embolism: a Randomized, Placebo-controlled, Double-blind Trial." Blood, vol. 109, no. 1, 2007, pp. 139-44.
den Heijer M, Willems HP, Blom HJ, et al. Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. Blood. 2007;109(1):139-44.
den Heijer, M., Willems, H. P., Blom, H. J., Gerrits, W. B., Cattaneo, M., Eichinger, S., ... Bos, G. M. (2007). Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. Blood, 109(1), pp. 139-44.
den Heijer M, et al. Homocysteine Lowering By B Vitamins and the Secondary Prevention of Deep Vein Thrombosis and Pulmonary Embolism: a Randomized, Placebo-controlled, Double-blind Trial. Blood. 2007 Jan 1;109(1):139-44. PubMed PMID: 16960155.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Homocysteine lowering by B vitamins and the secondary prevention of deep vein thrombosis and pulmonary embolism: A randomized, placebo-controlled, double-blind trial. AU - den Heijer,Martin, AU - Willems,Huub P J, AU - Blom,Henk J, AU - Gerrits,Wim B J, AU - Cattaneo,Marco, AU - Eichinger,Sabine, AU - Rosendaal,Frits R, AU - Bos,Gerard M J, Y1 - 2006/09/07/ PY - 2006/9/9/pubmed PY - 2007/2/21/medline PY - 2006/9/9/entrez SP - 139 EP - 44 JF - Blood JO - Blood VL - 109 IS - 1 N2 - The Vitamins and Thrombosis (VITRO) study investigated the effect of homocysteine lowering by daily supplementation of B vitamins on the risk reduction of deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients between 20 to 80 years old with a first objectively confirmed proximal DVT or PE in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent was obtained, patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine, and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End points were objectively diagnosed recurrent DVT or PE. A total of 701 patients were enrolled (360 in the hyperhomocysteinemic and 341 in the normohomocysteinemic group). The number of recurrent events of venous thrombosis was 43 of 353 in the vitamin group (54/1000 py) and 50 of 348 in the placebo group (64/1000 py). The hazard ratio associated with vitamin treatment was 0.84 (95% CI, 0.56-1.26): 1.14 (95% CI, 0.65-1.98) in the hyperhomocysteinemic group and 0.58 (95% CI, 0.31-1.07) in the normohomocysteinemic group. The results of our study do not show that homocysteine lowering by B vitamin supplementation prevents recurrent venous thrombosis. SN - 0006-4971 UR - https://www.unboundmedicine.com/medline/citation/16960155/Homocysteine_lowering_by_B_vitamins_and_the_secondary_prevention_of_deep_vein_thrombosis_and_pulmonary_embolism:_A_randomized_placebo_controlled_double_blind_trial_ L2 - http://www.bloodjournal.org/cgi/pmidlookup?view=long&pmid=16960155 DB - PRIME DP - Unbound Medicine ER -