DALLAS, Nov. 15, 2021 — 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,” said study author Rafael Díaz, M.D., director of Estudios Clínicos Latinoamérica in Rosario, Argentina. “It’s unclear if a larger trial might support or refute the positive trends noted here with high-dose IPE treatment.”
Co-authors are Deepak L. Bhatt, M.D., M.P.H., FAHA; Andrés Orlandini, M.D.; Alan Go, M.D.; Andrew Ambrosy, M.D.; Preston Mason, M.B.A., Ph.D.; Tabassome Simon, M.D., Ph.D.; Philippe Steg, M.D.; and Subodh Verma, M.D., Ph.D. Authors’ disclosures are listed in the abstract.
The study was funded by a grant from Amarin.
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