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Ensayo controlado aleatorizado2019

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

Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Albert CM, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE, VITAL Research Group

The New England journal of medicine · 744 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación independiente
Gobierno
Office of Dietary Supplements
Gobierno
National Institutes of Health
Gobierno
National Heart, Lung, and Blood Institute
Gobierno
National Institute of Mental Health
Gobierno
National Cancer Institute
Gobierno
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Gobierno
NIAMS NIH HHS
Gobierno
NCI NIH HHS
Gobierno
NIMH NIH HHS
Gobierno
NHLBI NIH HHS
Subvenciones
National Cancer Institute (U01CA138962); National Institute of Mental Health (R01MH091448); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Heart, Lung, and Blood Institute (R0 CA138962); National Heart, Lung, and Blood Institute (R01 HL116690); National Cancer Institute (R01CA138962)

Según 10 financiadores declarados.

Publicación

Publicado
2018-11-10 · N Engl J Med · vol. 380 · número 1 · págs. 23–32
Editorial
Massachusetts Medical Society
Citado
978 citas · más que el 100% de estudios similares · 78.2× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
94 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Fatty Acid Research and Health · Nutritional Studies and Diet · Aquaculture Nutrition and Growth
Palabras clave
omega-3 fatty acids, cardiovascular disease prevention, cancer prevention, primary prevention, cardiovascular events, myocardial infarction, stroke, cancer mortality, coronary revascularization, dietary supplementation, cardiovascular risk reduction, cancer risk reduction, older adults, Black participants, cancer risk factors
MeSH
humans, neoplasms, cardiovascular diseases, fatty acids, omega-3, treatment failure, incidence, follow-up studies, aged, middle aged, female, male

17 autores

  • JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University
  • Nancy R. Cook🇺🇸Brigham and Women's Hospital; Harvard University
  • I‐Min Lee🇺🇸Brigham and Women's Hospital; Harvard University
  • William G. Christen🇺🇸Brigham and Women's Hospital; Harvard University
  • Shari S. Bassuk🇺🇸Brigham and Women's Hospital; Harvard University
  • Samia Mora🇺🇸Brigham and Women's Hospital; Harvard University
  • Heike Luttmann‐Gibson🇺🇸Brigham and Women's Hospital; Harvard University
  • Christine M. Albert🇺🇸Brigham and Women's Hospital; Harvard University
  • David Gordon🇺🇸Brigham and Women's Hospital; Harvard University
  • Trisha Copeland🇺🇸Brigham and Women's Hospital; Harvard University
  • Denise D’Agostino🇺🇸Brigham and Women's Hospital; Harvard University
  • Georgina Friedenberg🇺🇸Brigham and Women's Hospital; Harvard University
  • Claire Ridge🇺🇸Brigham and Women's Hospital; Harvard University
  • Vadim Y. Bubes🇺🇸Brigham and Women's Hospital; Harvard University
  • Edward L. Giovannucci🇺🇸Brigham and Women's Hospital; Harvard University
  • Walter Churchill Willett🇺🇸Brigham and Women's Hospital; Harvard University
  • Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

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.

Methods

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.

Results

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.

Conclusions

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 .).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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