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
The Omega-3 fatty acids have received considerable attention for its potential cardiovascular benefits recently. Still, the effect of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in reducing cardiovascular risk is unclear. The author Nicholls and colleagues (2020) conducted a study titled “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” published on JAMA network. The summary of findings is given below:
Objectives:
To investigate the effect of carboxylic acid formulation of EPA and DHA (omega-3 CA) on clinical outcomes in patients with a high risk of cardiovascular disease.
Method:
Total 13,078 statin-treated patients with high cardiovascular risk, low levels of high-density lipoprotein cholesterol (HDL-C), and hypertriglyceridemia were included in the study. A double-blind, randomized, multicenter trial was conducted for comparing omega-3 CA with corn oil in these participants at 675 academic and community hospitals in 22 countries.
Findings:
Findings suggest no effect of omega-3 CA in reducing the composite endpoint of cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, or coronary revascularization as compared with the use of corn oil. The previous research has reported positive outcomes with the administration of purified formulations of EPA. On the other hand, this study included omega-3 CA which was a combination of EPA and DHA.
Although previous studies have reported that EPA and DHA have different biological effects; investigators add that, lack of cardiovascular benefits might suggest an adverse effect of co-administration of DHA in this study. There was an association found between omega-3 CA administration and increased rate of gastrointestinal adverse events and study drug discontinuation. Additionally, there was an increase in the new onset of atrial fibrillation in patients receiving omega-3 CA. This finding is notable as the positive benefit observed with purified EPA might have been related to an increase in event rates in the mineral oil placebo treatment group.
Hence it is still unclear to identify whether the administration of any omega-3 fatty acid formulation is beneficial or not.
Limitation:
Whether omega-3 CA administration will benefit the population with a lower risk of the cardiovascular event remains unclear as the study included participants with a high risk of future cardiovascular events. The study included the fixed proportion of EPA and DHA administration (4g/d), hence the effect of different doses and proportion on cardiovascular risk is unknown. Lastly, there are no large clinical trials to study the effect of DHA on cardiovascular events conducted to date.
Image Credit: Image by Elias Shariff Falla Mardini from Pixabay