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Grand Rounds

More from the VITAL Trial: Do Omega-3 Fatty Acids Reduce Cardiovascular and Cancer Risk in the General Population?

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BACKGROUND AND PURPOSE:

  • Manson et al. (NEJM, 2018) sought to determine whether marine n-3 (omega-3) fatty acids reduce risk for cardiovascular disease and cancer in the general population

METHODS:

  • Randomized, double-blind placebo-controlled trial (RCT)
  • VITAL trial (VITamin D and OmegA-3 TriaL)
  • Two-by-two factorial design
  • Vitamin D3: 2000 IU per day
  • Marine n-3 fatty acids: 1 g per day as a fish-oil capsule containing 840 mg of n−3 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA])
  • Participants
  • Men: ≥50 years
  • Women: ≥55 years
  • Primary outcomes
  • Major cardiovascular events (composite of myocardial infarction, stroke, or death from cardiovascular causes)
  • Invasive cancer (any)
  • Secondary outcomes
  • Site-specific cancers | Death from cancer | Additional cardiovascular events

RESULTS:

  • 25,871 participants underwent randomization, including 5106 participants
    • There was a median follow-up of 5.3 years

There were no differences for primary outcomes

  • Major cardiovascular event
    • 386 participants in the n−3 group
    • 419 in the placebo group
    • hazard ratio (HR) 0.92 (95% CI, 0.80 to 1.06; P=0.24)
  • Invasive cancer
    • 820 participants in the n−3 group
    • 797 in the placebo group
    • HR 1.03 (95% CI, 0.93 to 1.13; P=0.56)

There were no significant differences for secondary outcomes

  • In the analyses of key secondary end points, HRs were as follows
    • Expanded composite end point of cardiovascular events: 0.93 (95% CI, 0.82 to 1.04)
    • Total myocardial infarction: 0.72 (95% CI, 0.59 to 0.90)
    • Total stroke: 1.04 (95% CI, 0.83 to 1.31)
    • Death from cardiovascular causes: 0.96 (95% CI, 0.76 to 1.21)
    • Death from cancer: 0.97 (341 deaths from cancer; 95% CI, 0.79 to 1.20)
  • Death from any cause: HR 1.02 (95% CI, 0.90 to 1.15)
  • No excess risks of bleeding or other serious adverse events were observed

CONCLUSION:

  • Supplementation with n-3 fatty acids did not reduce risk of major cardiovascular events or cancer, compared to placebo

Learn More – Primary Sources:

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

Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

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Related ObG Topics:

Cochrane Review: Do Omega-3 Fatty Acids Reduce Cardiovascular Disease? 
Omega-3 PUFAs: Do They Really Work for the Treatment of Dementia?
PURE Study Results – Carbs vs Fat Intake to Reduce Cardiovascular Morbidity and Mortality?

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