n-3 fatty acids and cardiovascular events after myocardial infarction
BACKGROUND: Results from prospective cohort studies and randomized, controlled trials have provided evidence of a protective effect of n-3 fatty acids against cardiovascular diseases. We examined the effect of the marine n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and of the plant-derived alpha-linolenic acid (ALA) on the rate of cardiovascular events among patients who have had a myocardial infarction.
METHODS: In a multicenter, double-blind, placebo-controlled trial, we randomly assigned 4837 patients, 60 through 80 years of age (78% men), who had had a myocardial infarction and were receiving state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy to receive for 40 months one of four trial margarines: a margarine supplemented with a combination of EPA and DHA (with a targeted additional daily intake of 400 mg of EPA-DHA), a margarine supplemented with ALA (with a targeted additional daily intake of 2 g of ALA), a margarine supplemented with EPA-DHA and ALA, or a placebo margarine. The primary end point was the rate of major cardiovascular events, which comprised fatal and nonfatal cardiovascular events and cardiac interventions. Data were analyzed according to the intention-to-treat principle, with the use of Cox proportional-hazards models.
RESULTS: The patients consumed, on average, 18.8 g of margarine per day, which resulted in additional intakes of 226 mg of EPA combined with 150 mg of DHA, 1.9 g of ALA, or both, in the active-treatment groups. During the follow-up period, a major cardiovascular event occurred in 671 patients (13.9%). Neither EPA-DHA nor ALA reduced this primary end point (hazard ratio with EPA-DHA, 1.01; 95% confidence interval [CI], 0.87 to 1.17; P=0.93; hazard ratio with ALA, 0.91; 95% CI, 0.78 to 1.05; P=0.20). In the prespecified subgroup of women, ALA, as compared with placebo and EPA-DHA alone, was associated with a reduction in the rate of major cardiovascular events that approached significance (hazard ratio, 0.73; 95% CI, 0.51 to 1.03; P=0.07). The rate of adverse events did not differ significantly among the study groups.
CONCLUSIONS: Low-dose supplementation with EPA-DHA or ALA did not significantly reduce the rate of major cardiovascular events among patients who had had a myocardial infarction and who were receiving state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy. (Funded by the Netherlands Heart Foundation and others; ClinicalTrials.gov number, NCT00127452.).
| Errataetall: |
CommentIn: Nat Rev Cardiol. 2010 Nov;7(11):598. - PMID 21080603 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2010 |
|---|---|
| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:363 |
|---|---|
| Enthalten in: |
The New England journal of medicine - 363(2010), 21 vom: 18. Nov., Seite 2015-26 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kromhout, Daan [VerfasserIn] |
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| Links: |
|---|
| Anmerkungen: |
Date Completed 23.11.2010 Date Revised 20.01.2023 published: Print-Electronic ClinicalTrials.gov: NCT00127452 CommentIn: Nat Rev Cardiol. 2010 Nov;7(11):598. - PMID 21080603 Citation Status MEDLINE |
|---|
| doi: |
10.1056/NEJMoa1003603 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a ClinicalTrials.gov: NCT00127452 | ||
| 500 | |a CommentIn: Nat Rev Cardiol. 2010 Nov;7(11):598. - PMID 21080603 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Results from prospective cohort studies and randomized, controlled trials have provided evidence of a protective effect of n-3 fatty acids against cardiovascular diseases. We examined the effect of the marine n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and of the plant-derived alpha-linolenic acid (ALA) on the rate of cardiovascular events among patients who have had a myocardial infarction | ||
| 520 | |a METHODS: In a multicenter, double-blind, placebo-controlled trial, we randomly assigned 4837 patients, 60 through 80 years of age (78% men), who had had a myocardial infarction and were receiving state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy to receive for 40 months one of four trial margarines: a margarine supplemented with a combination of EPA and DHA (with a targeted additional daily intake of 400 mg of EPA-DHA), a margarine supplemented with ALA (with a targeted additional daily intake of 2 g of ALA), a margarine supplemented with EPA-DHA and ALA, or a placebo margarine. The primary end point was the rate of major cardiovascular events, which comprised fatal and nonfatal cardiovascular events and cardiac interventions. Data were analyzed according to the intention-to-treat principle, with the use of Cox proportional-hazards models | ||
| 520 | |a RESULTS: The patients consumed, on average, 18.8 g of margarine per day, which resulted in additional intakes of 226 mg of EPA combined with 150 mg of DHA, 1.9 g of ALA, or both, in the active-treatment groups. During the follow-up period, a major cardiovascular event occurred in 671 patients (13.9%). Neither EPA-DHA nor ALA reduced this primary end point (hazard ratio with EPA-DHA, 1.01; 95% confidence interval [CI], 0.87 to 1.17; P=0.93; hazard ratio with ALA, 0.91; 95% CI, 0.78 to 1.05; P=0.20). In the prespecified subgroup of women, ALA, as compared with placebo and EPA-DHA alone, was associated with a reduction in the rate of major cardiovascular events that approached significance (hazard ratio, 0.73; 95% CI, 0.51 to 1.03; P=0.07). The rate of adverse events did not differ significantly among the study groups | ||
| 520 | |a CONCLUSIONS: Low-dose supplementation with EPA-DHA or ALA did not significantly reduce the rate of major cardiovascular events among patients who had had a myocardial infarction and who were receiving state-of-the-art antihypertensive, antithrombotic, and lipid-modifying therapy. (Funded by the Netherlands Heart Foundation and others; ClinicalTrials.gov number, NCT00127452.) | ||
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| 700 | 1 | |a de Goede, J |e investigator |4 oth | |
| 700 | 1 | |a Oude Griep, L M |e investigator |4 oth | |
| 700 | 1 | |a Teitsma-Jansen, A M |e investigator |4 oth | |
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| 700 | 1 | |a Mulder, B J M |e investigator |4 oth | |
| 700 | 1 | |a Deckers, J W |e investigator |4 oth | |
| 700 | 1 | |a Katan, M B |e investigator |4 oth | |
| 700 | 1 | |a Zock, P L |e investigator |4 oth | |
| 700 | 1 | |a de Boer, M J |e investigator |4 oth | |
| 700 | 1 | |a de Leeuw, H |e investigator |4 oth | |
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| 700 | 1 | |a van Kempen, L H J |e investigator |4 oth | |
| 700 | 1 | |a Bakx, A |e investigator |4 oth | |
| 700 | 1 | |a Sedney, M I |e investigator |4 oth | |
| 700 | 1 | |a Hertzberger, D P |e investigator |4 oth | |
| 700 | 1 | |a Michels, H R |e investigator |4 oth | |
| 700 | 1 | |a de Rotte, A A |e investigator |4 oth | |
| 700 | 1 | |a van Rugge, R P |e investigator |4 oth | |
| 700 | 1 | |a Klootwijk, A |e investigator |4 oth | |
| 700 | 1 | |a Verheul, J A |e investigator |4 oth | |
| 700 | 1 | |a Nicastia, D M |e investigator |4 oth | |
| 700 | 1 | |a de Medina, R Robles |e investigator |4 oth | |
| 700 | 1 | |a van Rossem, M |e investigator |4 oth | |
| 700 | 1 | |a Leenders, C M |e investigator |4 oth | |
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| 700 | 1 | |a Uppal, S C |e investigator |4 oth | |
| 700 | 1 | |a Blok, J G |e investigator |4 oth | |
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| 700 | 1 | |a Umans, V A W M |e investigator |4 oth | |
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| 700 | 1 | |a Konst, L |e investigator |4 oth | |
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