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Folic acid and B12 do not prevent CV events

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In this large randomized trial by SEARCH group, no benefit of homocysteine lowering treatment was obsreved among MI survivors

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Folic acid and B12 do not prevent CV events

  1. 1. www.pronutritionist.net Effects of Homocysteine-Lowering With Folic Acid Plus Vitamin B12 vs Placebo on Mortality and Major Morbidity in Myocardial Infarction Sur vivors A Randomized Trial SEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494 Page 1 SEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  2. 2. Page 2 Background (1/2) • Intake of folic acid is low in many developed countries like Finland. In USA flour and grain products are fortified with folic acid since 1998 • Lack of dietary folic acid is associated neural tube defects of offspring and increased cardiovascular risk • Vitamin B12 is found only in foods from animal origin. Usual intake of vitamin B12 is on adequate level in most developed countries • Lack of vitamin B12 is not connected with increased cardiovascular risk in most studies www.pronutritionist.netSEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  3. 3. Page 3 Background (2/2) • Both folic acid and vitamin B12 decrease homocysteine levels • High serum homocysteine levels are associated with increased cardiovascular risk in cohort and cross sectional studies • In a Norwegian randomized trial, lowering homocysteine with folic acid, vitamin B12 and vitamin B6 did not bring any benefit for CAD patients (Ebbing et al. 2008) www.pronutritionist.netSEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  4. 4. Methods • n=12 064 MI survivors from UK (83 % males) • Randomized controlled trial, 2x2 factorial • Duration: 6.7 years • Primary outcome: First major vascular event, defined as major coronary event (coronary death, myocardial infarction, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization. • Secondary outcome: cognitive function, cancers, blood pressure, hearing loss, fractures • Intervention: 2 mg folic acid plus 1 mg vitamin B daily vs matching placebo. 4 www.pronutritionist.netSEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  5. 5. Results, primary outcomes • 11 945 patients completed study (drop out rate 1 %) • Allocation to the study vitamins reduced homocysteine by 28 % (a mean of 3.8 µmol/L • Risk of any major vascular event after folic acid and vitamin B12 was 1.04 vs placebo • No effect was seen in stroke, coronary events or noncoronary revascularizations either • Number of deaths were equal in both groups • The results were consistent across all the sub-populations analysed 21.12.145 SEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  6. 6. Results, secondary outcomes • No difference in blood pressure was seen • No difference in cognitive function was seen • Occurrence of dementia was similar in both groups • Occurrence of non-traumatic fractures was similar in both groups • Occurrence of hearing loss was similar in both groups • Occurrence of cancers were similar in both groups 21.12.146 SEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494
  7. 7. Discussion • In this study no benefit at all was found with homocysteine lowering treatment with folic acid and vitamin B12 • Unlike in some previous studies, no deleterious effect on incidence of cancers was observed • There is no evidence that homocysteine lowering treatments decrease cardiovascular morbidity or mortality in randomized controlled trials • Safety of high dose folic acid and vitamin B12 was good, no detrimental effects on health were observed • Adequate folic acid intake remains essential to prevent neural tube defects 7 www.pronutritionist.netSEARCH Collaborative Group. JAMA. 2010;303(24):2486-2494

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