Cited by 511Fatty Acid Research and HealthNutritional Studies and DietLipoproteins and Cardiovascular Health

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

The Risk and Prevention Study Collaborative Group·2013·New England Journal of Medicine

DOI 10.1056/nejmoa1205409

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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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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
DOI: 10.1056/nejmoa1205409
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 › Cardiology and Cardiovascular Medicine › 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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n–3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors

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