Cardiovascular outcome trial · N Engl J Med 2019
VITAL trial
Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer.
The bottom line
Daily supplementation with 1 g marine omega-3 fatty acids did not reduce the incidence of major cardiovascular events or invasive cancer compared with placebo, though it was safe and reduced total myocardial infarction as a secondary finding.
No significant benefitUS status: OTC supplement / Rx omega-3 ethyl esters
At a glance
- Medicine
- Marine n-3 fatty acids at a dose of 1 g per day
- Compared with
- Placebo
- People
- 25,871
- Who took part
- Men 50 years of age or older and women 55 years of age or older in the United States, primary prevention population, including 5106 black participants
- Design
- randomized, placebo-controlled trial, with a two-by-two factorial design
- Follow-up
- median follow-up of 5.3 years
- Main question
- Major cardiovascular events (composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type
Main result
Major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% 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).
Other results
For death from cardiovascular causes, hazard ratio 0.96 (95% CI, 0.76 to 1.21); for death from cancer (341 deaths from cancer), hazard ratio 0.97 (95% CI, 0.79 to 1.20); death from any cause (978 deaths overall), hazard ratio 1.02 (95% CI, 0.90 to 1.15). Key secondary: 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).
Safety
No excess risks of bleeding or other serious adverse events were observed.
In the trial's own words
“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).”
Quoted from the abstract of N Engl J Med 2019, checked word for word against PubMed. PubMed 30415637 · Full paper (DOI)
Common questions
What did the VITAL trial find?
Daily supplementation with 1 g marine omega-3 fatty acids did not reduce the incidence of major cardiovascular events or invasive cancer compared with placebo, though it was safe and reduced total myocardial infarction as a secondary finding.
Who was in VITAL?
25,871 people. Men 50 years of age or older and women 55 years of age or older in the United States, primary prevention population, including 5106 black participants.
What was VITAL's main result?
Major cardiovascular event occurred in 386 participants in the n-3 group and in 419 in the placebo group (hazard ratio, 0.92; 95% 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).
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- ASCEND (2018)In diabetic patients without known cardiovascular disease, daily 1-g omega-3 fatty acid supplementation did not reduce serious vascular events compared with placebo.
- STRENGTH (2020)In statin-treated high-risk patients, adding high-dose omega-3 carboxylic acids to usual therapy did not reduce major adverse cardiovascular events compared with corn oil and caused more GI side effects.
- PROMINENT (2022)In patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia, and low HDL/LDL cholesterol, pemafibrate lowered triglycerides and related lipid markers but did not reduce cardiovascular events compared with placebo and increased risks of renal events and venous thromboembolism.
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