A high dose of a purified omega-3 fatty acid, available only by prescription, was well tolerated; however, it has not significantly reduced incidents of hospitalizations and / or death among people with COVID-19, according to a late-breaking clinical trial presented today at the 2021 American Heart Association Scientific Sessions . The meeting is completely virtual, on Saturday 13 November. -Monday November 15, 2021, and is a leading global exchange of the latest scientific advancements, research, and evidence-based clinical practice updates in cardiovascular science for healthcare worldwide.
Researchers set out to determine whether a high dose of pure eicosapentaenoic acid ethyl ester (EPA), called icosapent ethyl (IPE), would reduce the rate of hospitalizations and / or death in people with COVID-19.
Prevention and Treatment of COVID-19 with EPA in At-Risk Subjects – The Intervention Trial (PREPARE-IT 2) included approximately 2,000 men and women, aged 40 and over, who were tested positive for COVID-19 and had symptoms of the infection (fever, cough, sore throat, shortness of breath, or muscle pain) for 7 days or less before enrollment in the study, but did not clearly need hospitalization. Participants were randomized to receive either IPE or placebo pills. People in the treatment arm received 8 grams of EPI as 4 capsules every 12 hours with food for 3 days, followed by 4 grams of EPI as 2 capsules every 12 hours with food. during days 4-28. Neither the patients nor their healthcare professional knew whether they were receiving the PEI or the placebo.
A subset of patients were asked to self-report the severity of their symptoms using a validated symptom diary, the FLU-PRO assessment, at study baseline and at 28 days.
The researchers found that the IPE treatment was safe and well tolerated, although there was a slightly higher rate of participants who stopped taking the pills in the IPE group. There was a positive trend, although not statistically significant, for benefit with treatment.
Prescription PEI has been approved by the FDA as an adjunct to reduce the risk of cardiovascular events in some patients. PREPARE-IT 2 used twice the FDA-approved dose of EPI as a “loading dose” on the first three days of treatment to examine the safety and tolerability of the higher dose of EPI. 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 the observable results, loading doses of IPE were safe and well tolerated. It is not clear whether a larger-scale trial could support or refute the positive trends noted here with the high-dose IPE treatment. “
Rafael Díaz, MD, author of the study, director of Estudios Clínicos Latinoamérica in Rosario, Argentina
American Heart Association