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The analysis expanded upon a well-known trial called REDUCE-IT, which evaluated the use of icosapent ethyl in 8,000 patients.
By: Mike Montemarano
March 31, 2020
Researchers expanding upon a trial called REDUCE-IT, which evaluated the cardiovascular health impact of purified fish oil, believe that a medical-grade fish oil, icosapent ethyl, can prevent 70,000 cardiovascular-related deaths per year in the U.S. The results of this REDUCE-IT indicated that those on the purified fish oil benefitted substantially from icosapent ethyl (IE), a highly-purified fish oil therapy. It was published in the New England Journal of Medicine in 2019. Icosapent Ethyl is a pharmaceutical-grade fish oil drug with a high EPA content which is currently marketed by a company called Amarin under the name Vascepa, and was recently approved for use by the U.S. Food and Drug Administration in conjunction with maximally tolerated statin therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels. It is available as a prescription drug and is not sold over the counter. REDUCE-IT was a double-blind, placebo-controlled trial which evaluated the cardiovascular health outcomes of patients with elevated triglyceride levels despite the use of statin. Half of the 8,000-plus participants received two milligrams of icosapent ethyl twice daily, while the other half were a placebo group. In the IE group, 17.2% of patients had adverse cardiovascular events including cardiovascular death, compared to 22% of the patients in the placebo group. “In REDUCE-IT, the risk of the primary composite end point of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina[…] was significantly lower, by 25% among the patients who received 2 g of icosapent ethyl twice daily than among those who received placebo,” REDUCE-IT authors wrote, indicating that the number needed to treat was 21 people. Researchers from the UCI School of Medicine used the REDUCE-IT findings to conduct a meta-analysis in order to estimate how many deaths could be prevented yearly in the U.S. through the use of purified, prescription-strength fish oil. The group, led by Nathan D. Wong, PhD, utilized data from the CDC’s National Health and Nutrition Examination Survey (NHANES) alongside the criteria from REDUCE-IT. Wong suggested that positive results seen in REDUCE-IT were not found in other trials possibly due to mixtures with other omega-3 fatty acids such as DHA, or inadequate dosages. “Our analysis extends the findings of the REDUCE-IT trial by estimating its potential impact on the U.S. population,” Wong said. “By using inclusion criteria and cardiovascular disesase event rates from the REDUCE-IT trial and applying it to data on U.S. adults from NHANES, we were able to estimate the beneficial impact icosapent ethyl could have on preventing initial and total cardiovascular events in eligible U.S. adults with cardiovascular disease or diabetes and multiple risk factors.” “When you consider that for every 21 patients treated with icosapent ethyl you can spare a cardiovascular event, you begin to see the implications of our results,” Wong continued.
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