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DUBLIN, Ireland and BRIDGEWATER, N.J., March 31, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), hosted a webcast yesterday to discuss important data with study authors who presented at the American College of Cardiology’s 69th Annual Scientific Session Together With World Congress of Cardiology (ACC.20/WCC), March 28-30. The data presented related to VASCEPA® (icosapent ethyl) capsules, the landmark clinical outcomes study REDUCE-IT®, as well as persistent cardiovascular risk in patients with elevated triglycerides, a type of fat in the blood.
“Administration of 4 g/day of VASCEPA, a highly cost-effective therapy, can potentially prevent over 70,000 cardiovascular events per year,” said Craig Granowitz, M.D., Ph.D., Amarin’s senior vice president and chief medical officer commenting on presentations made at ACC.20/WCC. “It is apparent that icosapent ethyl administration results in serum EPA levels necessary to reduce cardiovascular events. This positive effect has not been demonstrated for any other therapy on top of statin therapy. These new and important data will help inform ways to manage persistent cardiovascular risk and help curb the number one killer of Americans.”
About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise.1,2 There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are similar, accounting for 1 of every 19 U.S. deaths (approximately 1 every 40 seconds).3 In aggregate, from cardiovascular disease there is one death, stroke or heart attack every 14 seconds.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35% – but that still leaves a 65-75% risk remaining.4 People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.5,6,7
Key Data Presented at ACC.20/WCC and Reviewed During Amarin’s Webcast
“Eicosapentaenoic Acid Levels in REDUCE-IT and Cardiovascular Outcomes”– presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital
Highlights: Following administration of VASCEPA, a pure, stable, prescription EPA therapy, serum EPA levels showed an approximately 400% increase across the study from baseline (26.1 μg/mL) versus placebo, including to year 1 (144 μg/mL; p=1x10-30). Docosahexaenoic acid (DHA) levels were measured and showed a decrease of 2.9% (p=0.002).
On-treatment EPA levels in the VASCEPA group were associated strongly with reduced cardiovascular events, including benefits observed in the primary and key secondary endpoints, each component of these endpoints such as cardiovascular death, as well as benefits in heart failure and total mortality with high on-treatment EPA levels.
These analyses suggest that achieved EPA levels with 4 g/day of VASCEPA is a marker for the majority of the relative risk reduction observed in REDUCE-IT. The EPA levels achieved in REDUCE-IT were well above levels that can be achieved with diet or with dietary supplements. The clinical results achieved with VASCEPA have not been demonstrated for any other therapy, reflecting the uniqueness of this FDA-approved prescription therapy and its high EPA content, in stable form, without offset or dilution by other omega-3 molecules each of which act differently (e.g., enhanced dosing of DHA is associated with increases in LDL-cholesterol levels). Further study is needed to assess whether people with relatively large body mass might be safely and effectively treated with higher than 4 g/day of icosapent ethyl.
Biomarker analyses suggest minimal contribution of changes in measured lipid, lipoprotein, and inflammatory biomarkers to the cardiovascular benefit observed in REDUCE-IT.
“REDUCE-IT Eligibility and Preventable First and Total Cardiovascular Events in the US Population: An Analysis of the National Health and Nutrition Examination Survey (NHANES)” – Nathan D. Wong, Wenjun Fan, Peter P. Toth, Craig Granowitz, Sephy Philip
Highlights: The NHANES database was used to identify approximately 3 million REDUCE-IT eligible adults aged >45 years, 63% with prior CVD and 37% with DM + >1 risk factor. While this is not the full extent of VASCEPA’s label, this is the population reviewed in this presented analysis.
Based on such eligibility criteria and event rate applied to the US population, it is estimated that administration of VASCEPA (icosapent ethyl) could prevent 71,391 cardiovascular events/year, consisting of 29,798/year fewer first occurrence of a cardiovascular events, such as stroke, heart attack or death, and 41,593/year fewer recurring cardiovascular events.
“Cost-effectiveness of Icosapent Ethyl in US REDUCE-IT Patients” – William S. Weintraub, Deepak L. Bhatt, Zugui Zhang, Cheng Zhang, Sarahfaye Dolman, William E. Boden, P. Gabriel Steg, Michael Miller, Eliot A. Brinton, Jordan B. King, Adam P. Bress, Terry A. Jacobson, Jean-Claude Tardif, Christie M. Ballantyne, Paul Kolm
Highlights: Based on a variety of cost-effectiveness analyses conducted, icosapent ethyl is shown to provide excellent value. The results show a dominant (better outcome, lower cost) cost-effectiveness profile overall and in patients with established atherosclerosis. Analyses conducted consistently put icosapent ethyl within US willingness-to-pay thresholds of
