n–3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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; ClinicalTrials.gov number, NCT00317707.).
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More recent omega-3 therapy outcome studies conducted in the presence of statins have been less encouraging, but evaluated nonhypertriglyceridemic patient populations and administered low doses of long-chain omega-3 fatty acids.
“Other more recent omega‐3 therapy outcome studies conducted in the presence of statins have been less encouraging, but these studies were characterized by evaluating nonhypertriglyceridemic patient populations (eg, TG <200 mg/dL) and administering low doses of long‐chain omega‐3 fatty acids (eg, eicosapentaenoic acid [EPA] and/or docosoahexaenoic acid [DHA]).19, 20, 21, 22, 23, 24”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [23]
Even among omega-3 fatty acid studies, there are marked differences with respect to the relatively low doses of omega-3 administered and the ratio of EPA to DHA.
“Even among omega‐3 fatty acid studies, there are marked differences with respect to the relatively low doses of omega‐3 administered and the ratio of EPA to DHA.16, 17, 18, 19, 20, 21, 22, 23, 24”
From Rationale and design of <scp>REDUCE‐IT</scp> : Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (2017) · cites this paper as [23]
Regardless of the dose of omega-3 fatty acid supplementation implemented in the trials and potential-related benefits on cardiovascular outcomes, omega-3 fatty acid supplementation may increase the risk for atrial fibrillation.
“proposing that regardless of the dose of O3FA supplementation implemented in the trials and potential-related benefits on CV outcomes, O3FA supplementation may increase the risk for AF.”
From Omega-3 fatty acids supplementation and risk of atrial fibrillation: an updated meta-analysis of randomized controlled trials (2021) · cites this paper as [5]
Even lower doses of omega-3 fatty acid supplementation have shown a potential signal for increased risk for atrial fibrillation.
“Even lower doses of O3FA supplementation has shown a potential signal for increased risk for AF,2,4,5”
From Omega-3 fatty acids supplementation and risk of atrial fibrillation: an updated meta-analysis of randomized controlled trials (2021) · cites this paper as [5]
Habitual excess energy intakes as small as ~50 kcal/day can explain the gradual weight gain occurring in most individuals.
“consistent with habitual excess energy intakes as small as ~50 kcal/day explaining the gradual weight gain occurring in most individuals.40”
From Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review (2016) · cites this paper as [40]
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- Authors
- The Risk and Prevention Study Collaborative Group
- Affiliations
- Mario Negri Institute for Pharmacological Research (IT)
- Corresponding author
- The Risk and Prevention Study Collaborative Group
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2013-05-09
- Volume
- 368
- Issue
- 19
- Pages
- 1800-1808
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2614282478
- Cited by
- 510
- References
- 12
- Citations by year
- 2026: 10 · 2025: 14 · 2024: 22 · 2023: 27 · 2022: 31 · 2021: 27 · 2020: 48 · 2019: 33 · 2018: 39 · 2017: 45 · 2016: 45 · 2015: 52 · 2014: 79 · 2013: 38
- FWCI
- 66.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi del Molise (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Keywords
- omega-3 fatty acids, omega-3 polyunsaturated fatty acids, cardiovascular risk factors, atherosclerosis, cardiovascular mortality, cardiovascular morbidity, myocardial infarction, stroke, olive oil placebo
- MeSH terms
- Aged, Cardiovascular Diseases, Double-Blind Method, Female, Hospitalization, Humans, Male, Middle Aged, Primary Prevention, Risk Factors, Fatty Acids, Omega-3, Proportional Hazards Models, Treatment Failure, Kaplan-Meier Estimate, General Practice
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