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Randomized trial · measured the question itself

Trial in 13,078 high-risk adults on statins: omega-3 did not clearly change heart events

Nicholls and colleagues · JAMA · 2020

Original title: Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.

Under review. A person has not yet checked this summary against the paper. It is written from the PubMed abstract. Until a person checks it, search engines are asked not to list this page.

What the study found

No difference

Heart events: 785 patients (12.0%) with omega-3 vs 795 (12.2%) with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]). Stomach side effects: 24.7% vs 14.7%. The trial stopped early.

The study at a glance

Type of study
Randomized trial
Who or what was studied
13,078 people · adults on statins at high heart risk, with high triglycerides and low HDL cholesterol
What was tested
4 g a day of an EPA and DHA omega-3 pill versus corn oil, on top of usual care
What it measured
The question itself: heart attacks, strokes and heart deaths
Daily amount
4 g a day
Trial registration
NCT02104817
Who has a stake
Company stake
Authors report AstraZeneca grants, fees, shares or jobs; AstraZeneca made the omega-3 pill tested (Epanova).
Journal
JAMA, 2020
Source
PubMed record 33190147. This page is based on the abstract only.

How much this study counts

  • ✓Randomized: people were put into groups by chance, so the groups start out alike.
  • ✓Large: 13,078 people.
  • ✓Measured the question itself: heart attacks, strokes and heart deaths.
  • –Company stake: Authors report AstraZeneca grants, fees, shares or jobs; AstraZeneca made the omega-3 pill tested (Epanova).
  • •Summarized from the PubMed abstract only. The full paper may hold details the abstract leaves out.

✓ Strength– Limit• Note

These points come from fixed rules about the type of study, its size and length, what it measured, and who has a stake. Every study on Digestery gets the same rules.

Where this study sits

Each dot is one on-topic paper on this question. Steps near the top answer the question more directly.

↑ Stronger evidence

  1. Trials in people: heart attacks, strokes and heart deaths

    11

    7 benefit, 4 no difference

    ↑ This study is the ringed dot

  2. Trials in people: other measures

    3

    1 benefit, 2 no difference

  3. Trials in people: lab tests or safety

    0

    None among the papers we read.

  4. Population studies

    0

    None among the papers we read.

  5. Blood levels and genes

    0

    None among the papers we read.

↓ Weaker evidence

  • Points to benefit
  • Mixed
  • No difference
  • No direction
  • Points to harm

How it fits with the other research

The short answer to “Does fish oil prevent heart disease?”

Little or no effect in most trials.

Confidence: moderate. Based on 21 on-topic papers.

Read the full answer

Of the other 10 papers on the same step: 7 benefit, 3 no difference. This one found no difference. It differs from most of them.

Other papers on the same step

See all 21 studies on this question

How this page was made

Label

First read of the abstract
Claude Sonnet
Independent second read
Claude Haiku
Differences settled
The reviewer corrected 1 field after reading the abstract. Claude Opus 5.5.
Headline
Claude Sonnet, from the checked study record. A script checked its numbers and wording.
Numbers
Checked against the abstract by a script
“How much this study counts”
Fixed rules, the same for every study
Source check by a person
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