Studie

Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk (STRENGTH)

Nicholls SJ, Lincoff A, Garcia M, et al.

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL Tier 1 2020

4 g/day EPA+DHA carboxylic acid (Epanova) showed no cardiovascular benefit vs corn oil and was stopped early for futility.

StudiedesignRANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
TierTier 1, Human RCT on the exact molecule
År2020
TidskriftJAMA
Publiceradnov 15, 2020
Tillagd i NO1GEVITYaug 7, 2026

STRENGTH randomiserade 13 708 statinbehandlade patienter med hög kardiovaskulär risk och hypertriglyceridemi. Epanova visade ingen signifikant nytta jämfört med placebo. The trial was stopped early for futility after 3.5 years. Triglycerides decreased 19% with omega-3 vs 0.9% with corn oil (P<0.001), but this did not translate to event reduction. Atrial fibrillation was significantly increased (2.2% vs 1.3%, P<0.001), as were gastrointestinal adverse events. A secondary analysis (JAMA Cardiol 2021) found no benefit even in patients achieving the highest EPA blood levels.

Among patients with high cardiovascular risk, the addition of omega-3 fatty acids to statin therapy did not reduce the composite outcome of major adverse cardiovascular events.
Kritikernoter

The contrast with REDUCE-IT raises the possibility that pure EPA is more effective than EPA+DHA combined, or that the mineral oil placebo in REDUCE-IT inflated its apparent benefit. Both trials found increased atrial fibrillation.

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