A high dose of a purified omega-3 fatty acid, available by prescription only, was well tolerated; however, it did not substantially reduce incidents of hospitalizations and/or deaths among people with COVID-19, according to a late-breaking clinical trial presented today at the American Heart Association's Scientific Sessions 2021. The meeting is fully virtual, Saturday, November 13-Monday, November 15, 2021, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.
Researchers sought to determine whether a high dose of pure eicosapentaenoic acid (EPA) ethyl ester, called icosapent ethyl (IPE), would reduce the rate of hospitalizations and/or death among people with COVID-19.
The Prevention and Treatment of COVID-19 With EPA in Subjects at Risk - Intervention Trial (PREPARE-IT 2) included approximately 2,000 men and women, ages 40 and older, who tested positive for COVID-19 and experienced symptoms of the infection (fever, cough, sore throat, shortness of breath or muscle aches) for 7 days or less prior to study enrollment but did not clearly require hospitalization. Participants were randomized to receive either IPE or placebo pills. Those in the treatment arm received 8 grams of IPE as 4 capsules every 12 hours with food for 3 days, followed by 4 grams of IPE as 2 capsules every 12 hours with food for days 4-28. Neither the patients nor their health care professional knew if they received IPE or the placebo.
A subgroup of patients was asked to self-report the severity of their symptoms using a validated symptom diary, the FLU-PRO assessment, at the start of the study and at 28 days.
The researchers found that IPE treatment was safe and well tolerated, though there was a slightly higher rate of participants who stopped taking the pills in the IPE group. There was a positive, though not statistically significant, trend for a benefit with the treatment.
Prescription IPE has been approved by the FDA as an adjunctive therapy to reduce risk of cardiovascular events in some patients. PREPARE-IT 2 used twice the FDA-approved dose of IPE as a "loading dose" the first three days of treatment to examine the safety and tolerability of the higher dose of IPE. A loading dose is a higher amount of medicine given initially, before switching to a lower maintenance dose for the duration of treatment.
Based on observable outcomes, loading doses of IPE were safe and well tolerated. It's unclear if a larger trial might support or refute the positive trends noted here with high-dose IPE treatment."
Rafael Díaz, M.D., study author, director of Estudios Clínicos Latinoamérica in Rosario, Argentina
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