News Release

Prescription omega-3 pill didn’t affect outcome for non-hospitalized adults with COVID-19

American Heart Association Scientific Sessions 2021, LBS .06

Reports and Proceedings

American Heart Association

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.

Additional Resources:

Statements and conclusions of studies that are presented at the American Heart Association’s scientific meetings are solely those of the study authors and do not necessarily reflect the Association’s policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers and the Association’s overall financial information are available here.

The American Heart Association’s Scientific Sessions 2021 is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care professionals worldwide. The 3-day meeting will feature more than 500 sessions focused on breakthrough cardiovascular basic, clinical and population science updates in a fully virtual experience Saturday, November 13 through Monday, November 15, 2021. Thousands of leading physicians, scientists, cardiologists, advanced practice nurses and allied health care professionals from around the world will convene virtually to participate in basic, clinical and population science presentations, discussions and curricula that can shape the future of cardiovascular science and medicine, including prevention and quality improvement. During the three-day meeting, attendees receive exclusive access to more than 4,000 original research presentations and can earn Continuing Medical Education (CME), Continuing Education (CE) or Maintenance of Certification (MOC) credits for educational sessions. Engage in Scientific Sessions 2021 on social media via #AHA21.

About the American Heart Association

The American Heart Association is a relentless force for a world of longer, healthier lives. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public’s health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.orgFacebookTwitter or by calling 1-800-AHA-USA1.


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