Assessment of omega-3 carboxylic acids in statin-treated patients with high levels of triglycerides and low levels of high-density lipoprotein cholesterol: rationale and design of the STRENGTH trial
Open accessAbstract
It is uncertain whether omega‐3 fatty acids are beneficial in statin‐treated patients. Epanova is a mix of omega‐3 free fatty acids, not requiring co‐ingestion with food, which can lower triglycerides by up to 31%. STRENGTH will examine whether Epanova 4 g daily reduces the rate of cardiovascular events in statin‐treated patients with hypertriglyceridemia and low levels of HDL‐C at high risk for developing cardiovascular events. STRENGTH is a randomized, double‐blind, placebo‐controlled trial. Patients had a triglyceride level ≥ 180 to <500 mg/dL and HDL‐C < 42 mg/dL (men) or < 47 mg/dL (women) in the presence of either (1) established atherosclerotic cardiovascular disease, (2) diabetes with one additional risk factor, or (3) were other high‐risk primary prevention patients, based on age and risk factor assessment. Patients should be treated with a statin, for >4 weeks, and have LDL‐C < 100 mg/dL, but were also eligible if LDL‐C was ≥100 mg/dL while on maximum tolerated statin therapy. The study will extend from October 30, 2014 to October 30, 2019. 13 086 patients were randomized to Epanova 4 g or placebo daily in addition to standard medical therapy. The primary efficacy outcome is time to first event of cardiovascular death, myocardial infarction, stroke, coronary revascularization or hospitalization for unstable angina. The trial will continue until 1600 patients reach the primary endpoint, with a median duration of therapy of 3 years. STRENGTH will determine whether Epanova 4 g daily will reduce cardiovascular events in statin‐treated high‐risk patients with hypertriglyceridemia and low HDL‐C levels.
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Among outcomes trials with omega-3 preparations, only REDUCE-IT has shown cardiovascular benefits.
“although only REDUCE-IT has shown cardiovascular benefits (as discussed later) (14-17).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
Section 4 (Omega-3 Fatty Acids; page not supplied) reports a 19% reduction in cardiovascular events in JELIS, contrary to the claim that only REDUCE-IT had shown benefit. It also describes REDUCE-IT as still investigating cardiovascular outcomes, not as a trial that had already shown benefit. (LLM, conf=0.92)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe STRENGTH trial tested a 4 g/day dose of an EPA/DHA carboxylic acid formulation in patients with high TG and low HDL-C, was stopped early for futility, and showed no CVD benefit.
“Conversely, the STRENGTH trial, which tested a 4 g/day dose of an EPA/DHA carboxylic acid formulation in patients with high TG and low HDL-C, was stopped early for futility and showed no CVD benefit [95].”
From Targeting Triglycerides in Cardiovascular Disease Prevention: Evidence, Mechanisms, and Emerging Therapies (2026) · cites this paper as [95]
The STRENGTH Trial Objectives and Design section describes Epanova 4 g daily, an EPA/DHA treatment, and the Abstract identifies statin-treated patients with high triglycerides and low HDL-C. This 2018 rationale-and-design paper describes the trial as ongoing; it does not report that STRENGTH stopped early or found no cardiovascular benefit. The Statistical Considerations section discusses planned futility assessments, not an actual stop. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the STRENGTH trial, an increased rate of investigator-reported new-onset AF was observed in the omega-3 carboxylic acid-treated group compared with corn oil (2.2% vs 1.3%; HR: 1.69; 95% CI: 1.29-2.21; nominal P < 0.001).
“An increased rate of investigator-reported new-onset AF was also observed in the STRENGTH trial among individuals in the omega-3 carboxylic acid–treated group compared with corn oil (2.2% vs 1.3%; HR: 1.69; 95% CI: 1.29-2.21; nominal P < 0.001) (14).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
The trial design section (Section 6; page unavailable) identifies Epanova and corn oil as the treatment groups, and the endpoints section (Section 10; page unavailable) lists new-onset atrial fibrillation as a tertiary endpoint. This rationale-and-design paper does not report the claimed AF rates, hazard ratio, confidence interval, or P value. (LLM, conf=0.88)
Experimental — accuracy not yet measuredMultiple randomized controlled trials of prescription ethyl ester and carboxylic acid preparations of DHA and EPA mixtures and pure EPA as IPE at higher doses (1.8 to 4 g daily) have demonstrated an increase in the risk of AF with therapy.
“Multiple randomized controlled trials of prescription ethyl ester and carboxylic acid preparations of DHA and EPA mixtures and pure EPA as IPE at higher doses (1.8 to 4 g daily) have demonstrated an increase in the risk of AF with therapy (14,15,24).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
The Omega-3 Fatty Acids and Epanova sections describe EPA and EPA/DHA preparations studied at doses from 1.8 to 4 g/day. But the paper does not report that these trials found an increased risk of atrial fibrillation; the Endpoints section lists new-onset atrial fibrillation only as an outcome the STRENGTH trial will assess. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn STRENGTH, the primary endpoint occurred in 12.0% of patients treated with omega-3 carboxylic acid versus 12.2% of patients treated with placebo (HR 0.99; 95% CI 0.90-1.09; P = 0.84).
“The primary endpoint of cardiovascular death, MI, stroke, coronary revascularization, or unstable angina requiring hospital admission occurred in 785 (12.0%) patients treated with omega-3 carboxylic acid versus 795 (12.2%) patients treated with placebo (HR: 0.99; 95% CI: 0.90-1.09; P = 0.84).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
The ENDPOINTS section (page unavailable) defines the primary composite endpoint as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina. But this is a rationale-and-design paper: STATISTICAL CONSIDERATIONS and TRIAL PROGRESS (pages unavailable) describe planned analyses and enrollment, not the reported event counts, percentages, hazard ratio, confidence interval, or P value. (LLM, conf=0.86)
Experimental — accuracy not yet measured
In STRENGTH, omega-3 carboxylic acid reduced triglycerides from a median level of 239 mg/dL by 19% versus 0.9% in the placebo group and reduced non-HDL-C by 6.1% versus 1.1% in the placebo group.
“In regard to lipids, the omega-3 carboxylic acid preparation reduced triglycerides from a median level of 239 mg/dL by 19% (vs 0.9% reduction in the placebo group) and non–HDL-C by 6.1% (vs 1.1% reduction in the placebo group).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
Section 5 (EPANOVA) reports reductions in triglycerides and non-HDL-C with Epanova, but those findings are from earlier trials, not STRENGTH. Sections 6 (STRENGTH TRIAL OBJECTIVES AND DESIGN) and 12 (TRIAL PROGRESS) describe STRENGTH as ongoing; our copy does not report its lipid results or the claimed baseline and percentage changes. (LLM, conf=0.82)
Experimental — accuracy not yet measuredHigh-intensity statin therapy is consistently associated with greater triglyceride reduction than moderate- or low-intensity statins.
“Such treatment is of particular benefit to patients with hypertriglyceridemia, as high-intensity statin therapy is consistently associated with greater triglyceride reduction than moderate- or low-intensity statins (106).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
Section 2 (page not specified) says statins produce limited triglyceride lowering, supporting only the general point that statins can lower triglycerides. It does not compare high-, moderate-, and low-intensity statins or establish that higher intensity consistently produces greater reductions. (LLM, conf=0.80)
Experimental — accuracy not yet measuredSome omega-3 dietary supplements contain cholesterol, oxidized fatty acids, saturated fatty acids, or other contaminants that can affect their net risk-benefit relationship.
“Apparently independently of formulation, some omega-3 dietary supplements contain cholesterol, oxidized fatty acids, saturated fatty acids, or other contaminants that can affect their net risk-benefit relationship.57,105”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [105]
Section 4, “Omega-3 Fatty Acids” (page unavailable), discusses variable formulation bioavailability and uncertain cardiovascular benefit, but not the composition or contamination of dietary supplements. Searches for cholesterol, oxidized fatty acids, saturated fatty acids, and contaminants in supplements found no passage addressing the claimed effect on their risk-benefit relationship. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn STRENGTH, new-onset atrial fibrillation increased in the omega-3 carboxylic acid group compared with placebo (2.2% vs 1.3%; HR 1.69; 95% CI 1.29-2.21; nominal P < 0.001).
“In regard to adverse effects, new-onset AF increased in the omega-3 carboxylic acid group compared with placebo (2.2% vs 1.3%; HR: 1.69; 95% CI: 1.29-2.21; nominal P < 0.001).”
From 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia (2021) · cites this paper as [14]
The Endpoints section lists new-onset atrial fibrillation as a planned tertiary endpoint, but this rationale-and-design paper does not report trial outcomes. A search for the reported event rates, hazard ratio, and adverse-effect results found no passage supporting the claimed increase. (LLM, conf=0.78)
Experimental — accuracy not yet measuredOther meta-analyses suggest reduced major cardiovascular events in patients with high triglycerides and low HDL cholesterol treated with fibrates, but no decrease in cardiovascular or total mortality.
“Results from other meta-analyses suggest reduced major CVD events in patients with high TGs and low HDL-C in fibrate-treated patients, but no decrease in CVD or total mortality [314-316].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [316]
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- Authors
- Nicholls, S. J., Lincoff, A. M., Bash, D., Ballantyne, C. M., Barter, P. J., Davidson, M. H., Kastelein, J. J. P., Koenig, W., McGuire, D. K., Mozaffarian, D., Pedersen, T. R., Ridker, P. M., Ray, K., Karlson, B. W., Lundström, T., Wolski, K., & Nissen, S. E.
- Affiliations
- South Australian Health and Medical Research Institute (AU)
- Cleveland Clinic (US)
- Baylor College of Medicine (US)
- UNSW Sydney (AU)
- University of Chicago (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- Deutsches Herzzentrum München Technische Universität München, and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance Munich Germany
- The University of Texas Southwestern Medical Center (US)
- Tufts University (US)
- Oslo University Hospital (NO)
- Harvard University (US)
- Imperial College London (GB)
- AstraZeneca (Sweden) (SE)
- Corresponding author
- Nicholls, Stephen J.
- ORCID
- Venue
- Clinical Cardiology
- Publisher
- Wiley
- Published
- 2018-09-28
- Volume
- 41
- Issue
- 10
- Pages
- 1281-1288
- ISSN
- 0160-9289 (ISSN-L)
- 1932-8737
- PMC
- PMC6489732
- OpenAlex
- W2888211838
- Cited by
- 167
- References
- 45
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 4 · 2023: 4 · 2022: 9 · 2021: 27 · 2020: 54 · 2019: 54 · 2018: 6 · 2017: 1
- FWCI
- 4.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Cardiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- AstraZeneca Pharmaceuticals
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- omega-3 fatty acids, statin therapy, hypertriglyceridemia, low HDL cholesterol, cardiovascular events, primary prevention, atherosclerotic cardiovascular disease, diabetes mellitus
- MeSH terms
- Carboxylic Acids, Cardiovascular Diseases, Humans, Cholesterol, HDL, Risk Factors, Triglycerides, Global Health, Hypertriglyceridemia, Fatty Acids, Omega-3, Incidence, Randomized Controlled Trials as Topic, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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