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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
STRENGTH randomized 13,078 statin-treated high-risk patients to 4 g/day omega-3 carboxylic acids (EPA/DHA formulation) versus corn oil; the trial was stopped early for futility with no significant reduction in the primary composite of major adverse cardiovascular events.
Design
- Double-blind RCT; n = 13,078 at 675 sites (22 countries)
- Arms: omega-3 carboxylic acids (EPA/DHA) 4 g/day vs corn oil comparator on top of usual care including statins
- Primary endpoint: CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalisation
- Stopping: trial halted after 1,384 primary events when interim monitoring indicated low probability of benefit
Primary result
- Primary endpoint HR 0.99 (95% CI 0.90–1.09; P = 0.84) for omega-3 CA vs corn oil
Safety / tolerability signal
- GI adverse events: 24.7% (omega-3 CA) vs 14.7% (corn oil)
Evidence hygiene
- Comparator matters: this trial is not identical to REDUCE-IT (different product class, population, and control); do not merge effect sizes across trials.
- Interpretation: null MACE result for this high-dose carboxylic-acid formulation versus corn oil in this eligibility frame.
Publication
Nicholls SJ, Lincoff AM, Garcia M, et al. JAMA. 2020 Nov 15;324(22):2268–2280. PMID 33190147.
Outcomes
- All-Cause Mortality RiskEvents: /
- Gastrointestinal adverse events 24.7% on omega-3 carboxylic acids vs 14.7% on corn oil.