Funded in part by Amgen, Eli Lilly and Company, AstraZeneca, Novo Nordisk, Esperion Therapeutics
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
Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundström T, Agrawal R, Menon V, Wolski K, Nissen SE
JAMA · 762 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Industry funded
- Company
- Amgen
- Company
- Eli Lilly and Company
- Company
- AstraZeneca
- University or hospital
- Cleveland Clinic
- Company
- Novo Nordisk
- Company
- Esperion Therapeutics
Based on 6 listed funder(s).
Publication
- Published
- 2020-11-15 · JAMA · vol. 324 · issue 22 · p. 2268
- Publisher
- American Medical Association
- Cited
- 1028 citations · more than 100% of similar papers · 64.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 35 works
- Access
- Free to read
- Research areas
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Natural Products and Biological Research
- Keywords
- Medicine, Adverse effect, Corn oil, Omega, Internal medicine
- MeSH
- humans, cardiovascular diseases, hypertriglyceridemia, cholesterol, corn oil, docosahexaenoic acids, eicosapentaenoic acid, triglycerides, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, double-blind method, adult, middle aged, female, male, heart disease risk factors
22 authors
From AU, US, NL, DE, GB, SE
- Stephen James NichollsMonash University
- A. Michael LincoffCleveland Clinic; Center for Clinical Research (United States)
- Michelle GarciaCleveland Clinic; Center for Clinical Research (United States)
- Dianna BashCleveland Clinic; Center for Clinical Research (United States)
- Christie Mitchell BallantyneBaylor College of Medicine
- Philip J. BarterUNSW Sydney
Abstract
Importance
It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.
Objective
To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.
Design, setting, and participants
A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.
Interventions
Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins.
Main outcomes and measures
The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
Results
When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
Conclusions and relevance
Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.
Trial registration
ClinicalTrials.gov Identifier: NCT02104817.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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