REDUCE-IT(R) Heart Failure Analyses by VASCEPA(R) (Icosapent Ethyl)-Driven Serum Eicosapentaenoic Acid (EPA) Levels Suggest Potential Benefit in New Heart Failure in Studied At-Risk Patients as Presented at the American College of Cardiology's 70th Annual Scientific Session
2021-05-15 08:00:00 AM ET (GlobeNewswire)
Post hoc analyses by estimated on-treatment serum EPA levels in the VASCEPA group suggest potentially reduced incidence of new heart failure and new heart failure requiring hospitalization with higher achieved serum EPA levels
Amarin to Webcast Discussion of Data Presented at ACC.21 Monday, May 17, 2021 at 4:30 p.m., Eastern Time
Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT HEART FAILURE (HF) at ACC.21, the American College of Cardiology's 70th Annual Scientific Session, being held virtually from May 15 - 17, 2021. These new analyses supported by Amarin were presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
"The REDUCE-IT HF analyses provide interesting data about a potential new approach to addressing heart failure, a condition that continues to challenge patients and cardiologists worldwide," commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT. "The potential benefit of increased serum EPA levels in reducing the composite of cardiovascular death or new heart failure requiring hospitalization in at-risk patients is a novel finding for icosapent ethyl and requires further prospective validation. These results add to the growing body of knowledge regarding icosapent ethyl."
The REDUCE-IT HF analyses examined the effects of icosapent ethyl on the incidence of new heart failure by achieved on-treatment serum EPA levels in REDUCE-IT patients. New heart failure and new heart failure requiring hospitalization were prespecified tertiary endpoints and were not significant in the overall patient population. Post hoc analyses were conducted based on estimated average on-treatment EPA levels in patients in the icosapent ethyl group with available EPA measurements, as compared to patients in the placebo group with available EPA measurements; these analyses showed that new heart failure and new heart failure requiring hospitalization may be reduced in patients who achieve serum EPA levels higher than approximately 150 ug/mL, though this needs to be tested prospectively.
As previously reported, the REDUCE-IT cardiovascular outcomes study enrolled 8,179 patients who were required to be treated with statins and other conventional therapies, and all patients had controlled low-density lipoprotein cholesterol, elevated triglyceride levels, and either established cardiovascular disease or diabetes with other cardiovascular risk factors.
Heart failure is a major and often debilitating cardiovascular condition, significantly impacting not only patients and their loved ones, but also healthcare systems globally. In the United States (US), the latest statistical update from the American Heart Association (AHA) shows that approximately 6.0 million people have HF, with the prevalence projected to increase by 46% from 2012 to 2030, affecting >8 million people 18 years of age or older. The overall US cost of HF continues to rise as well; in 2012 the total cost for HF was estimated to be $30.7 billion, primarily attributable to direct medical costs. The trajectory we are on could lead to a 127% (or $69.8 billion) increase by 2030.
"Cardiovascular disease continues to be the leading cause of death worldwide, with the economic and societal burden increasing each year," said Steven Ketchum, Ph.D., senior vice president and president, research & development, and chief scientific officer, Amarin. "Heart failure, in particular, devastates patients, their families and economies with significant direct costs and societal impact. We owe it to at-risk patients to analyze the data from our cardiovascular outcomes study and explore whether therapies such as icosapent ethyl might ease the burden."
The REDUCE-IT HF analyses include both prespecified and post hoc analyses. Heart failure was a prespecified tertiary endpoint within REDUCE-IT. Approximately 14% of the patients did not have EPA levels determined at baseline; baseline characteristics and outcomes in those with or without EPA measures were similar. On-treatment EPA values were estimated from available annual serum samples.
Brigham and Women's Hospital receives research funding from Amarin for Dr. Bhatt's work as the REDUCE-IT study Chair.
The REDUCE-IT HF analyses can be found here. Additional REDUCE-IT and icosapent ethyl (EPA)-related topics will be presented at ACC.21 and can be found here.
Audio Webcast Information
Amarin will host an audio webcast on Monday, May 17, 2021, at 4:30 p.m. ET to further discuss these and other VASCEPA-related findings presented during ACC.21, with replay available for a period of 14 days. The discussion will include various clinicians and scientists and will be moderated by Amarin's chief medical officer, Craig Granowitz, M.D., Ph.D. To listen please register here, listen live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-545-0320 within the United States, 973-528-0016 from outside the United States. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 within the United States, 919-882-2331, PIN: 41266. Any opinions or views expressed by the clinicians and scientists on the audio webcast are theirs alone. They have neither been scripted nor previewed by Amarin. While Amarin respects the scientific opinions of these clinicians and scientists, Amarin takes no responsibility for those opinions. Rather, this audio webcast is intended to provide summaries of recently presented scientific data for consideration by Amarin's investors.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.
