Randomised controlled trialindependent cross-checkabstract only checked I-SUP-09 standard review
REDUCE-IT: prescription EPA
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.
Overview
Bhatt DL et al.. N Engl J Med 2019 · PMID 30415628 · DOI 10.1056/NEJMoa1812792
High-dose purified EPA reduced cardiovascular events by 25% in high-risk patients; more AF.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
High-dose EPA.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
8,179.
- What was actually found?
Fewer events.
- How large was the observed effect?
HR 0.75.
- What do the results mean in everyday life?
Exception to 'omega-3 useless'.
- What are the study's limitations?
Industry; placebo debate.
- What does it say about Elawady's specific claim?
Limits C-SUP-05.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
OTC capsules.
Scientific in-depth review
1. Full reference
- Authors
- Bhatt DL et al.
- Journal
- N Engl J Med
- Year
- 2019
- Identifier
- PMID 30415628 DOI 10.1056/NEJMoa1812792
- Verification
- verified – PubMed efetch 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract | Funding (abstract): Amarin Pharma
2. Research question
Does icosapent ethyl reduce ischaemic events?
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre randomised double-blind placebo-controlled trial (REDUCE-IT)
- Population
Statin-treated with CVD or diabetes + risk factors, TG 135–499 mg/dL
- Country
Multinational
- Period
median 4.9 years
- Sample size
8,179
4. Methods and endpoints
- Exposure / intervention
Icosapent ethyl 4 g/day
- Comparator
Placebo
- Endpoints
CV death, MI, stroke, revascularisation, unstable angina
- Statistical methods
Cox
5. Actual results
- Results
Primary 17.2% vs 22.0%, HR 0.75 (0.68–0.83); key secondary HR 0.74; CV death 4.3% vs 5.2% HR 0.80; AF/flutter hospitalisation 3.1% vs 2.1%; serious bleeding 2.7% vs 2.1% (P=0.06).
- Absolute risks
Absolute reduction 4.8 percentage points (primary)
- Authors' conclusion
Lower ischaemic events including CV death with icosapent ethyl.
6. Strengths
- Large RCT
7. Weaknesses
- Industry-funded (Amarin)
- Placebo choice debated (not in abstract)
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Placebo comparator controversy not assessable from abstract.
9. Assessment of the statistical interpretation
10. Relevance to the specific claim
11. Independent contrary findings
STRENGTH (A-SUP-10) null.
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
A prescription exception; not over-the-counter fish oil.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | high |
| Directness | direct |
| Reproducibility | not replicated |
| Consistency with the overall evidence | inconsistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Role of placebo.
15. Linked fact checks
- When popular oral supplements (calcium, beta-carotene, vitamin E, omega-3, multivitamins, glucosamine, selenium, vitamin A) were tested in large long-term placebo-controlled trials, most failed to deliver the promised prevention of disease. – Studies contradicting or limiting the claim
- Omega-3 capsules do not prevent cardiovascular disease and increase the risk of atrial fibrillation; Elawady rejects omega-3 capsules. – Studies contradicting or limiting the claim