Results of STRENGTH Trial with Omega-3 Fatty Acids Question Validity of REDUCE-It Trial
Author: Frank Domino, MD
In the article below, I review a recent article published in the Journal of the American Medical Association which asks the question: Does high dose omega-3 fatty acid improve major adverse cardiac events in patients with high cardiovascular risk?
Title: Results of STRENGTH Trial with Omega-3 Fatty Acids Question Validity of REDUCE-It Trial
Reference: JAMA. 2020 Nov 15;e2022258. doi: 10.1001/jama.2020.22258
Study Summary: This was a randomized trial comparing high dose omega 3 fatty acids to a placebo (corn oil) in over 13,000 patients at high risk of cardiovascular (CV) events. The mean age was 62.5 years; 35% were women and 70% had diabetes. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. The study was halted prematurely after 5 plus years from randomization as the primary end point occurred in 785 patients (12.0%) treated with omega-3 vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84).
Conclusion: For patients at high risk of CV disease and already on a statin, adding Omega-3 fatty acids did NOT lower risk of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
Discussion: You may recall the Reduce-IT trial, an industry funded trial of a prescription omega-3 vs mineral oil. This study found worse outcomes in the mineral oil group compared to the omega-3 group. It appears it was not the prescription omega-3’s that improved outcomes, but their control, the mineral oil, made matters worse.
Bottom Line: Do not use omega-3 fatty acid supplements or by prescription to prevent cardiovascular outcomes. Encourage patients to eat fish twice a week.
Stats Refresher: A confidence interval is a range where 95% of the point estimates were found. For the Hazard Ratio, when the CI crosses 1.0, there is NO statistical difference between the intervention group and the control group; in this case, there was no benefit of the omega-3 compared to the control group.
Dr. Frank Domino, MD, is a Professor of Family Medicine and Community Health at the University of Massachusetts Medical School, Worcester, MA. The views expressed in this post are his own and are not reflective of views held by Pri-Med.
