n-3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors

Faculty of Medicine, University of Southampton, , Southampton, UK.
New England Journal of Medicine (Impact Factor: 55.87). 05/2013; 368(19):1800-8. DOI: 10.1056/NEJMoa1205409


Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction.
In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes.
Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points.
In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. (Funded by Società Prodotti Antibiotici and others; number, NCT00317707.).

Download full-text


Available from: Irene Marzona, Mar 04, 2014
31 Reads
  • Source
    • "There is observational evidence that dietary intake of omega-3 (n-3) PUFA is associated with a favorable lipoprotein profile especially with higher concentrations of HDL-particles and larger HDL particle size but also with lower concentrations of LDL particles and larger LDL particle size and decreasing concentration of VLDL particles and smaller VLDL particles [1,2]. However, daily treatment with n-3 fatty acids has not convincingly been associated with reduced cardiovascular morbidity and mortality [3,4]. It has been suggested that blood level of n-3 PUFAs may be a better indicator of cardiovascular risk than n-3 supplementation [5]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Cross-sectional studies have suggested that serum omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids (PUFAs) are related to favorable lipoprotein particle concentrations. We explored the associations of serum n-3 and n-6 PUFAs with lipoprotein particle concentrations and sizes in a general population cohort at baseline and after 6 years. The cohort included 665 adults (274 men) with a 6-year follow-up. Nutritional counseling was given at baseline. Serum n-3 and n-6 PUFAs and lipoprotein particle concentrations and the mean particle sizes of VLDL, LDL, and HDL were quantified by nuclear magnetic resonance (NMR) spectroscopy for all baseline and follow-up samples at the same time. Concentrations of n-3 and n-6 PUFAs were expressed relative to total fatty acids. At baseline, n-3 PUFAs were not associated with lipoprotein particle concentrations. A weak negative association was observed for VLDL (P = 0.021) and positive for HDL (P = 0.011) particle size. n-6 PUFA was negatively associated with VLDL particle concentration and positively with LDL (P < 0.001) and HDL particle size (P < 0.001). The 6-year change in n-3 PUFA correlated positively with the change in particle size for HDL and LDL lipoproteins but negatively with VLDL particle size. An increase in 6-year levels of n-6 PUFAs was negatively correlated with the change in VLDL particle concentration and size, and positively with LDL particle size. Change in circulating levels of both n-3 and n-6 PUFAs, relative to total fatty acids, during 6 years of follow-up are associated with changes in lipoprotein particle size and concentrations at the population level.
    Lipids in Health and Disease 02/2014; 13(1):28. DOI:10.1186/1476-511X-13-28 · 2.22 Impact Factor
  • Source
    • "In elderly, adherence to a Mediterranean-like dietary pattern was shown to reduced the 10-year mortality (Sjogren et al., 2010b). Longchain n-3 polyunsaturated fatty acids were shown to reduce inflammation, to improve insulin sensitivity and to reduce hypertriglyceridemia (Jacobson, 2008; Kelley et al., 2009; Wakutsu et al., 2010), although their role in the primary and secondary prevention of acute cardiovascular events remains controversial (Kromhout et al., 2010; Roncaglioni et al., 2013). Thus, besides quantitative recommendations aiming to reduce the risk of protein-energy wasting, present data argue for counselling to elderly people Mediterranean-like diets providing energy mainly in the form of fruits, vegetables, grains, olive and fish oils. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Protein-energy homeostasis is a major determinant of healthy aging. Inadequate nutritional intakes and physical activity, together with endocrine disturbances are associated with of sarcopenia and frailty. Guidelines from scientific societies mainly address the quantitative aspects of protein and energy nutrition in elderly. Besides these quantitative aspects of protein load, perspective strategies to promote muscle protein synthesis and prevent sarcopenia include pulse feeding, the use of fast proteins and the addition of leucine or citrulline to dietary protein. An integrated management of sarcopenia, taking into account the determinants of muscle wasting, i.e. nutrition, physical activity, anabolic factors such as androgens, vitamin D and n-3 polyunsaturated fatty acids status needs to be tested in the prevention and treatment of sarcopenia. The importance of physical activity, specifically resistance training, is emphasized, not only in order to facilitate muscle protein anabolism but also to increase appetite and food intake in elderly people at risk of malnutrition. According to present data, healthy nutrition in elderly should respect the guidelines for protein and energy requirement, privilege a Mediterranean way of alimentation, and be associated with a regular physical activity. Further issues relates to the identification of the genetics determinants of protein energy wasting in elderly.
    Mechanisms of ageing and development 01/2014; 136-137. DOI:10.1016/j.mad.2014.01.008 · 3.40 Impact Factor
  • Source
    • "In May 2013, The Risk and Prevention Study Collaborative Group (Italy) released a conclusive negative finding regarding fish oil for those patients with high risk factors but no previous myocardial infarction. Fish oil failed in all measures of cardiovascular disease (CVD) prevention—both primary and secondary [1]. This study was so conclusive that Eric Topol, MD, Editor-in-Chief of Medscape and Medscape's Heartwire for cardiologists, issued a new directive to patients to stop taking fish oil, that is, long-chain EFA metabolites of EPA/DHA [2]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: The medical community suffered three significant fish oil failures/setbacks in 2013. Claims that fish oil's EPA/DHA would stop the progression of heart disease were crushed when The Risk and Prevention Study Collaborative Group (Italy) released a conclusive negative finding regarding fish oil for those patients with high risk factors but no previous myocardial infarction. Fish oil failed in all measures of CVD prevention-both primary and secondary. Another major 2013 setback occurred when fish oil's DHA was shown to significantly increase prostate cancer in men, in particular, high-grade prostate cancer, in the Selenium and Vitamin E Cancer Prevention Trial (SELECT) analysis by Brasky et al. Another monumental failure occurred in 2013 whereby fish oil's EPA/DHA failed to improve macular degeneration. In 2010, fish oil's EPA/DHA failed to help Alzheimer's victims, even those with low DHA levels. These are by no means isolated failures. The promise of fish oil and its so-called active ingredients EPA / DHA fails time and time again in clinical trials. This lipids-based physiologic review will explain precisely why there should have never been expectation for success. This review will focus on underpublicized lipid science with a focus on physiology.
    01/2014; 2014(4):495761. DOI:10.1155/2014/495761
Show more