STRENGTH: Omega-3 Fatty Acids Fail To Improve CV Outcomes

A new analysis suggests that omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) failed to significantly improve cardiovascular outcomes compared with corn oil.

The paper, published in the Journal of the American Medical Association, reported the results of the STRENGTH study. STRENGTH was a double-blind, randomized trial that compared omega-3 carboxylic acid formulation of EPA and DHA with corn oil in a patient population of 13,078 statin-treated participants who had high cardiovascular risk, elevated triglycerides, and low HDL levels. Participants were randomized to either 4 g/day of omega-3 carboxylic acid (n=6,539) or corn oil (n=6,539) plus standard background therapy and statin treatment. The primary study endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

According to the study results, 1,384 participants experienced a study endpoint event, and the trial was suspended prematurely due to the low probability of clinical benefit of the omega-3 carboxylic acid formulation compared with corn oil. A total of 12,633 completed the trial with ascertainment of primary endpoint status. The primary endpoint occurred in 12.0% of patients in the omega-3 group vs. 12.2% in the corn oil arm (HR=0.99; 95% CI, 0.90 to 1.09; P=0.84). The authors reported an increase in gastrointestinal adverse events in the omega-3 group relative to the corn oil group (24.7% vs. 14.7%, respectively).

“Among statin-treated patients at high cardiovascular risk, the addition of omega-3 carboxylic acid, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events,” the authors concluded. “These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.”