Results confirm the interim analysis, whereby the study was suspended for futility. Omega-3 fatty acids do not reduce cardiovascular events in patients with high triglycerides and low HDL.
Previous studies, such as REDUCE-IT, had shown positive results, but given this new research (presented at the American Heart Association [AHA] 2020 Congress and simultaneously published in JAMA), we need to come to terms with the fact that omega-3 fatty acids provide no benefit.
The problem in REDUCE-IT was that the control arm received mineral oil. That has a pro-inflammatory effect: it increases LDL, apolipoprotein B, and C reactive protein. All of that supported the interpretation that the differences between treatment arms were linked to the benefit derived from omega 3 acids, when they were probably due to the adverse events in the control group.
However, in the STRENGTH study, the control arm used corn oil, which has a neutral effect.
The study included 13,078 patients under statin treatment, presenting high risk for cardiovascular events, with high triglycerides (180 to 500 mg/dl), and low HDL (<42 mg/dl in males and <47 mg/dl in women).
Participants were randomized to corn oil or omega 3 fatty acids (such as eicosapentaenoic acid and docosahexaenoic acid).
At a mean 42 months of follow-up, omega 3 fatty acids did not reduce cardiovascular death, infarction, coronary revascularization, or hospitalization for unstable angina (12.0% vs. 12.2%; hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.90-1.09).
There was an increased risk for new atrial fibrillation (2.2% vs. 1.3%; HR: 1.69; 95% CI: 1.29-2.21) with omega 3, which is consistent with the results of REDUCE-IT.
STRENGTHOriginal Title: 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.
Reference: Nicholls SJ et al. JAMA. 2020; Epub ahead of print y presentado en el congreso AHA 2020.
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