Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer

This article reports the n−3 fatty acid portion of a randomized, placebo-controlled, two-by-two factorial trial of vitamin D and marine n−3 fatty acids in the primary prevention of cancer and cardiovascular disease. Fatty acids did not lead to a lower incidence of major cardiovascular events or canc...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 380; no. 1; pp. 23 - 32
Main Authors Manson, JoAnn E, Cook, Nancy R, Lee, I-Min, Christen, William, Bassuk, Shari S, Mora, Samia, Gibson, Heike, Albert, Christine M, Gordon, David, Copeland, Trisha, D’Agostino, Denise, Friedenberg, Georgina, Ridge, Claire, Bubes, Vadim, Giovannucci, Edward L, Willett, Walter C, Buring, Julie E
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 03.01.2019
Subjects
Age
Aged
Cancer
Cardiovascular disease
Cardiovascular diseases
Cardiovascular Diseases - epidemiology
Cardiovascular Diseases - mortality
Cardiovascular Diseases - prevention & control
Cerebral infarction
Clinical trials
Death
Diabetes
Dietary supplements
Disease prevention
Drug dosages
Evidence-based medicine
Fatty acids
Fatty Acids, Omega-3 - adverse effects
Fatty Acids, Omega-3 - therapeutic use
FDA approval
Female
Fish oils
Follow-Up Studies
Health risk assessment
Heart attacks
Humans
Hypothesis testing
Incidence
Intervention
Investigations
Male
Middle Aged
Myocardial infarction
Neoplasms - epidemiology
Neoplasms - mortality
Neoplasms - prevention & control
Omega-3 fatty acids
Questionnaires
Stroke
Supplements
Treatment Failure
Vitamin D
Vitamin D3
Womens health
United States > US
Online AccessGet full text

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Abstract This article reports the n−3 fatty acid portion of a randomized, placebo-controlled, two-by-two factorial trial of vitamin D and marine n−3 fatty acids in the primary prevention of cancer and cardiovascular disease. Fatty acids did not lead to a lower incidence of major cardiovascular events or cancer.
AbstractList Higher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n-3 fatty acids has such effects in general populations at usual risk for these end points is unclear.BACKGROUNDHigher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n-3 fatty acids has such effects in general populations at usual risk for these end points is unclear.We conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (at a dose of 2000 IU per day) and marine n-3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type. Secondary end points included individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer. Safety was also assessed. This article reports the results of the comparison of n-3 fatty acids with placebo.METHODSWe conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (at a dose of 2000 IU per day) and marine n-3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type. Secondary end points included individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer. Safety was also assessed. This article reports the results of the comparison of n-3 fatty acids with placebo.A total of 25,871 participants, including 5106 black participants, underwent randomization. During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24). Invasive cancer was diagnosed in 820 participants in the n-3 group and in 797 in the placebo group (hazard ratio, 1.03; 95% CI, 0.93 to 1.13; P=0.56). In the analyses of key secondary end points, the hazard ratios were as follows: for the expanded composite end point of cardiovascular events, 0.93 (95% CI, 0.82 to 1.04); for total myocardial infarction, 0.72 (95% CI, 0.59 to 0.90); for total stroke, 1.04 (95% CI, 0.83 to 1.31); for death from cardiovascular causes, 0.96 (95% CI, 0.76 to 1.21); and for death from cancer (341 deaths from cancer), 0.97 (95% CI, 0.79 to 1.20). In the analysis of death from any cause (978 deaths overall), the hazard ratio was 1.02 (95% CI, 0.90 to 1.15). No excess risks of bleeding or other serious adverse events were observed.RESULTSA total of 25,871 participants, including 5106 black participants, underwent randomization. During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24). Invasive cancer was diagnosed in 820 participants in the n-3 group and in 797 in the placebo group (hazard ratio, 1.03; 95% CI, 0.93 to 1.13; P=0.56). In the analyses of key secondary end points, the hazard ratios were as follows: for the expanded composite end point of cardiovascular events, 0.93 (95% CI, 0.82 to 1.04); for total myocardial infarction, 0.72 (95% CI, 0.59 to 0.90); for total stroke, 1.04 (95% CI, 0.83 to 1.31); for death from cardiovascular causes, 0.96 (95% CI, 0.76 to 1.21); and for death from cancer (341 deaths from cancer), 0.97 (95% CI, 0.79 to 1.20). In the analysis of death from any cause (978 deaths overall), the hazard ratio was 1.02 (95% CI, 0.90 to 1.15). No excess risks of bleeding or other serious adverse events were observed.Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).CONCLUSIONSSupplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).
Higher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n-3 fatty acids has such effects in general populations at usual risk for these end points is unclear. We conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D (at a dose of 2000 IU per day) and marine n-3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type. Secondary end points included individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer. Safety was also assessed. This article reports the results of the comparison of n-3 fatty acids with placebo. A total of 25,871 participants, including 5106 black participants, underwent randomization. During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24). Invasive cancer was diagnosed in 820 participants in the n-3 group and in 797 in the placebo group (hazard ratio, 1.03; 95% CI, 0.93 to 1.13; P=0.56). In the analyses of key secondary end points, the hazard ratios were as follows: for the expanded composite end point of cardiovascular events, 0.93 (95% CI, 0.82 to 1.04); for total myocardial infarction, 0.72 (95% CI, 0.59 to 0.90); for total stroke, 1.04 (95% CI, 0.83 to 1.31); for death from cardiovascular causes, 0.96 (95% CI, 0.76 to 1.21); and for death from cancer (341 deaths from cancer), 0.97 (95% CI, 0.79 to 1.20). In the analysis of death from any cause (978 deaths overall), the hazard ratio was 1.02 (95% CI, 0.90 to 1.15). No excess risks of bleeding or other serious adverse events were observed. Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).
This article reports the n−3 fatty acid portion of a randomized, placebo-controlled, two-by-two factorial trial of vitamin D and marine n−3 fatty acids in the primary prevention of cancer and cardiovascular disease. Fatty acids did not lead to a lower incidence of major cardiovascular events or cancer.
BackgroundHigher intake of marine n−3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n−3 fatty acids has such effects in general populations at usual risk for these end points is unclear.MethodsWe conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (at a dose of 2000 IU per day) and marine n−3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type. Secondary end points included individual components of the composite cardiovascular end point, the composite end point plus coronary revascularization (expanded composite of cardiovascular events), site-specific cancers, and death from cancer. Safety was also assessed. This article reports the results of the comparison of n−3 fatty acids with placebo.ResultsA total of 25,871 participants, including 5106 black participants, underwent randomization. During a median follow-up of 5.3 years, a major cardiovascular event occurred in 386 participants in the n−3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.24). Invasive cancer was diagnosed in 820 participants in the n−3 group and in 797 in the placebo group (hazard ratio, 1.03; 95% CI, 0.93 to 1.13; P=0.56). In the analyses of key secondary end points, the hazard ratios were as follows: for the expanded composite end point of cardiovascular events, 0.93 (95% CI, 0.82 to 1.04); for total myocardial infarction, 0.72 (95% CI, 0.59 to 0.90); for total stroke, 1.04 (95% CI, 0.83 to 1.31); for death from cardiovascular causes, 0.96 (95% CI, 0.76 to 1.21); and for death from cancer (341 deaths from cancer), 0.97 (95% CI, 0.79 to 1.20). In the analysis of death from any cause (978 deaths overall), the hazard ratio was 1.02 (95% CI, 0.90 to 1.15). No excess risks of bleeding or other serious adverse events were observed.ConclusionsSupplementation with n−3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259.)
Author Bubes, Vadim
Bassuk, Shari S
Albert, Christine M
Lee, I-Min
Ridge, Claire
Willett, Walter C
Christen, William
Mora, Samia
Gordon, David
D’Agostino, Denise
Manson, JoAnn E
Friedenberg, Georgina
Copeland, Trisha
Giovannucci, Edward L
Cook, Nancy R
Gibson, Heike
Buring, Julie E
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  organization: From the Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health — all in Boston
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  surname: Buring
  fullname: Buring, Julie E
  organization: From the Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School (J.E.M., N.R.C., I-M.L., W.C., S.S.B., S.M., H.G., C.M.A., D.G., T.C., D.D., G.F., C.R., V.B., E.L.G., W.C.W., J.E.B.), and the Departments of Epidemiology (J.E.M., N.R.C., I.-M.L., W.C.W., J.E.B.) and Nutrition (E.L.G., W.C.W.), Harvard T.H. Chan School of Public Health — all in Boston
BackLink https://www.ncbi.nlm.nih.gov/pubmed/30415637$$D View this record in MEDLINE/PubMed
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Montgomery, Tony
Friedman, Sonia
Kalan, Kate
Demler, Olga
Samuelson, Harriet
Weekes, Sandra
Fonge, Yaneve
Girard, Lauren
Lin, Jennifer
Murray, Annie
Curran, Sara
Cohen, Lawrence S
Rexrode, Kathryn
Breen, Mary
Gaziano, J Michael
Liu, Lucy
Colton, Theodore
Fitchorov, Ivan
MacFadyen, Jean
Morse, Keith
Vinayagamoorthy, Manickavasagar
Clar, Allison
Forman, John
Hand, Laura
Arsenault, Leah
Botelho, Julianne
Albert, Michelle A
Werden, Meghan Rieu
Menjin, George
Perry, Megan
Riches, Naomi
Hollis, Bruce
Sesso, Howard
Van Denburgh, Marty
Schwerin, Kurt
Curry, Shamikhah
Pfeffer, Chris
Walter, Joseph
Moran, Alex
Li, Chunying
Walrond-Williams, Diana
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Wang, Thomas
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Haise, Kristen
Guzman, Vincent
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Bhang, Ellen
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Hasson, Katelyn
Liu, Yanyan
Zhang, Angela
Vesper, Hubert
Katz, Jeffrey
Smith, Doug
Pereira, Eduardo
Revilla, Maria
Pradhan, Aruna
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Gomelskaya, Natalya
Costenbader, Karen
Eldridge, David
Gold, Diane
Chen, Wendy
McMahon, Jennifer
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Copyright Copyright © 2018 Massachusetts Medical Society. All rights reserved.
Copyright_xml – notice: Copyright © 2018 Massachusetts Medical Society. All rights reserved.
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Snippet This article reports the n−3 fatty acid portion of a randomized, placebo-controlled, two-by-two factorial trial of vitamin D and marine n−3 fatty acids in the...
Higher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several...
BackgroundHigher intake of marine n−3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several...
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SubjectTerms Age
Aged
Cancer
Cardiovascular disease
Cardiovascular diseases
Cardiovascular Diseases - epidemiology
Cardiovascular Diseases - mortality
Cardiovascular Diseases - prevention & control
Cerebral infarction
Clinical trials
Death
Diabetes
Dietary supplements
Disease prevention
Drug dosages
Evidence-based medicine
Fatty acids
Fatty Acids, Omega-3 - adverse effects
Fatty Acids, Omega-3 - therapeutic use
FDA approval
Female
Fish oils
Follow-Up Studies
Health risk assessment
Heart attacks
Humans
Hypothesis testing
Incidence
Intervention
Investigations
Male
Middle Aged
Myocardial infarction
Neoplasms - epidemiology
Neoplasms - mortality
Neoplasms - prevention & control
Omega-3 fatty acids
Questionnaires
Stroke
Supplements
Treatment Failure
Vitamin D
Vitamin D3
Womens health
Title Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer
URI https://nejm.org/doi/full/10.1056/NEJMoa1811403
https://www.ncbi.nlm.nih.gov/pubmed/30415637
https://www.proquest.com/docview/2162818115
https://www.proquest.com/docview/2132258790
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