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      Cardiología "basada en la evidencia": aplicaciones prácticas de la epidemiología. II. El uso de biomarcadores Translated title: Evidence-Based Cardiology: practical applications from epidemiology. II. The use of biomarkers

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          Abstract

          El uso de biomarcadores que muestran una asociación con el desarrollo de enfermedad cardiovascular necesita una valoración cuidadosa de la calidad de la evidencia que establece su relación. Aunque los estudios observacionales han sido fundamentales para establecer la importancia de los factores de riesgo tradicionales, únicamente podemos hacer escrutinio e intervenir sobre biomarcadores cuando existe evidencia benéfica de estudios aleatorios clínicos controlados bien diseñados.

          Translated abstract

          The use of biomarkers that show an association with the development of cardiovascular disease needs a careful evaluation in regard to the quality of evidence that establishes their relationship. Although observational studies have been paramount to establish the importance of the traditional risk factors, we can only screen and intervene on biomarkers when there is demonstrated benefit in well-designed randomized clinical trials.

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          Most cited references22

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          Homocysteine lowering with folic acid and B vitamins in vascular disease.

          In observational studies, lower homocysteine levels are associated with lower rates of coronary heart disease and stroke. Folic acid and vitamins B6 and B12 lower homocysteine levels. We assessed whether supplementation reduced the risk of major cardiovascular events in patients with vascular disease. We randomly assigned 5522 patients 55 years of age or older who had vascular disease or diabetes to daily treatment either with the combination of 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12 or with placebo for an average of five years. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, and stroke. Mean plasma homocysteine levels decreased by 2.4 micromol per liter (0.3 mg per liter) in the active-treatment group and increased by 0.8 micromol per liter (0.1 mg per liter) in the placebo group. Primary outcome events occurred in 519 patients (18.8 percent) assigned to active therapy and 547 (19.8 percent) assigned to placebo (relative risk, 0.95; 95 percent confidence interval, 0.84 to 1.07; P=0.41). As compared with placebo, active treatment did not significantly decrease the risk of death from cardiovascular causes (relative risk, 0.96; 95 percent confidence interval, 0.81 to 1.13), myocardial infarction (relative risk, 0.98; 95 percent confidence interval, 0.85 to 1.14), or any of the secondary outcomes. Fewer patients assigned to active treatment than to placebo had a stroke (relative risk, 0.75; 95 percent confidence interval, 0.59 to 0.97). More patients in the active-treatment group were hospitalized for unstable angina (relative risk, 1.24; 95 percent confidence interval, 1.04 to 1.49). Supplements combining folic acid and vitamins B6 and B12 did not reduce the risk of major cardiovascular events in patients with vascular disease. (ClinicalTrials.gov number, NCT00106886; Current Controlled Trials number, ISRCTN14017017.). Copyright 2006 Massachusetts Medical Society.
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            Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials.

            Ecological and observational studies suggest that low vitamin D status could be associated with higher mortality from life-threatening conditions including cancer, cardiovascular disease, and diabetes mellitus that account for 60% to 70% of total mortality in high-income countries. We examined the risk of dying from any cause in subjects who participated in randomized trials testing the impact of vitamin D supplementation (ergocalciferol [vitamin D(2)] or cholecalciferol [vitamin D(3)]) on any health condition. The literature up to November 2006 was searched without language restriction using the following databases: PubMed, ISI Web of Science (Science Citation Index Expanded), EMBASE, and the Cochrane Library. We identified 18 independent randomized controlled trials, including 57 311 participants. A total of 4777 deaths from any cause occurred during a trial size-adjusted mean of 5.7 years. Daily doses of vitamin D supplements varied from 300 to 2000 IU. The trial size-adjusted mean daily vitamin D dose was 528 IU. In 9 trials, there was a 1.4- to 5.2-fold difference in serum 25-hydroxyvitamin D between the intervention and control groups. The summary relative risk for mortality from any cause was 0.93 (95% confidence interval, 0.87-0.99). There was neither indication for heterogeneity nor indication for publication biases. The summary relative risk did not change according to the addition of calcium supplements in the intervention. Intake of ordinary doses of vitamin D supplements seems to be associated with decreases in total mortality rates. The relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. Population-based, placebo-controlled randomized trials with total mortality as the main end point should be organized for confirming these findings.
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              Systematic review: Vitamin D and calcium supplementation in prevention of cardiovascular events.

              Vitamin D and calcium may affect the cardiovascular system independently and interactively. To assess whether vitamin D and calcium supplements reduce the risk for cardiovascular events in adults. Studies published in English from 1966 to July 2009 in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. Two investigators independently selected 17 prospective studies and randomized trials that examined vitamin D supplementation, calcium supplementation, or both and subsequent cardiovascular events. Three investigators extracted and checked data about study designs, participants, exposures or interventions, outcomes, and data quality. Five prospective studies of patients receiving dialysis and 1 study involving a general population showed consistent reductions in cardiovascular disease (CVD) mortality among adults who received vitamin D supplements. Four prospective studies of initially healthy persons found no differences in incidence of CVD between calcium supplement recipients and nonrecipients. Results of secondary analyses in 8 randomized trials showed a slight but statistically nonsignificant reduction in CVD risk (pooled relative risk, 0.90 [95% CI, 0.77 to 1.05]) with vitamin D supplementation at moderate to high doses (approximately 1000 IU/d) but not with calcium supplementation (pooled relative risk, 1.14 [CI, 0.92 to 1.41]), or a combination of vitamin D and calcium supplementation (pooled relative risk, 1.04 [CI, 0.92 to 1.18]) compared with placebo. Only articles published in English that reported cardiovascular event outcomes were included. The small number of studies, the lack of trials designed specifically to assess primary effects on cardiovascular outcomes, and important between-study heterogeneity preclude definitive conclusions. Evidence from limited data suggests that vitamin D supplements at moderate to high doses may reduce CVD risk, whereas calcium supplements seem to have minimal cardiovascular effects. Further research is needed to elucidate the role of these supplements in CVD prevention. The American Heart Association and the National Heart, Lung, and Blood Institute.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Journal
                acm
                Archivos de cardiología de México
                Arch. Cardiol. Méx.
                Elsevier (México )
                1405-9940
                June 2011
                : 81
                : 2
                : 158-161
                Affiliations
                [1 ] Mayo Clinic Florida
                [2 ] Mayo Clinic Minnesota USA
                Article
                S1405-99402011000200013
                56ffb545-7e09-411a-a74a-6a6a01b67f9a

                http://creativecommons.org/licenses/by/4.0/

                History
                Categories
                Cardiac & Cardiovascular Systems

                Cardiovascular Medicine
                Biomarkers,Observational studies,Randomized controlled trials,USA,Biomarcador,Estudios observacionales,Estudios aleatorios clínicos controlados,EUA

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