REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction in all-cause mortality

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, hosted a webcast today to discuss important data with study authors who presented at the American Heart Association 2019 Scientific Sessions, November 16-18. The data covered related to Vascepa® (icosapent ethyl) capsules, the landmark clinical outcomes study REDUCE-IT®[1] , as well as the cardiovascular risk of patients with elevated triglycerides, a type of fat in the blood.

“The more we study the REDUCE-IT data and the at-risk conditions of the patients studied in this important clinical trial, the better we understand the nature and extent of persistent cardiovascular risk among patients on statins and with elevated triglycerides, and how to address it,” said Craig Granowitz, M.D., Ph.D., chief medical officer, Amarin. “At Amarin, we are proud to have played a role in supporting and sharing data with the scientific and medical communities that could make a major difference in cardiovascular care, an area where the need for new and innovative treatment options is urgent and growing.”

About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise.2,[3] 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).4

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 high triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35% – but that still leaves 65-75% risk remaining.5 People with high triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,[7],[8]

Key Data Presented at AHA and Reviewed During Amarin’s Webcast

  • “REDUCE-IT USA: Results from the 3,146 Patients Randomized in the United States,” – presented by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital and Harvard Medical School.

    Highlights: This prespecified REDUCE-IT subgroup analysis showed substantial risk reductions in the USA patients treated with icosapent ethyl 4 g/day versus placebo across all prespecified composite and individual primary and secondary endpoints, including 31% relative risk reduction and 6.5% absolute risk reduction in first occurrence of 5-point major adverse cardiovascular events (MACE), corresponding to a number needed to treat of 15 (NNT=15), and a significant 30% relative and 2.6% absolute risk reduction (NNT=39) in all-cause mortality in the USA subgroup.

    Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results. These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.

    The REDUCE-IT USA subgroup consisted of 3,146 patients (nearly 40%) of the previously reported full trial cohort. REDUCE-IT was not specifically powered to examine individual subgroups. P-values presented for the USA subgroup are nominal and exploratory with no adjustment for multiple comparisons. Differences in efficacy outcomes for the USA patients are best viewed as qualitative and not quantitative; nevertheless, the data are useful and provide reassurance that the results in the USA are at least as strong as the results seen outside the USA and in the trial overall.

    The REDUCE-IT USA study results were also published in Circulation, AHA’s official scientific journal.9
  • “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” – presented by William S. Weintraub, M.D., MedStar Washington Hospital.

    Highlights: In this combined patient-level and simulation lifetime cost-effectiveness analysis, icosapent ethyl in high cardiovascular risk patients shows exceptional benefit with cardiovascular event reduction as well as cost-savings in-trial and over patients’ lifetime in many simulations. Findings of potential cost effectiveness of a medical therapy are rare. This analysis considered the current market cost for Vascepa and the potential savings from avoiding major adverse cardiovascular events, such as strokes and heart attacks, the cost of which can be high. This cost-effectiveness analysis was conducted by MedStar. As is typical, the cost-effectiveness analyses were not prespecified as part of the REDUCE-IT clinical trial design but did rely on the results of this landmark outcomes study.
     
  • “Many Statin Treated Persons with Borderline Triglyceride Levels are at Risk of ASCVD,” – presented by Nathan D. Wong, Ph.D., M.P.H, University of California, Irvine.  

    Highlights: This study showed prevalence of elevated risk of major cardiovascular events (a mean 10-year atherosclerotic cardiovascular disease (ASCVD) risk score greater than 20%) in more than 20% of patients on statins with triglycerides below 150 mg/dL. This suggests the need for greater lifestyle and other therapies to address remaining residual ASCVD risk.
     
  • “Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides (200 – 499 mg/dL) on Statin Therapy (EVAPORATE) study,” – presented by Matthew J. Budoff, M.D., Los Angeles Biomedical Research.

    Highlights: At the prespecified 9-month interim analysis, there was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque) (35% v. 43%, p=0.010), total plaque (non-calcified + calcified plaque) (p=0.0004), fibrous plaque (15% v. 26%, p=0.011) and calcified plaque (-1% v. 9%, p=0.001), after adjustment by baseline plaque, age, sex, diabetes status, baseline triglyceride levels, and statin use. However, there was no significant change in the primary endpoint of low attenuation plaque between active and placebo groups (74% vs 94%, p=0.469) at this 9-month interim look. This investigator-initiated study is continuing to its designed completion of an 18-month review.

    EVAPORATE is the first study in the United States, which enrolled a total of 80 patients, to use multidetector computed tomography (MDCT) to evaluate the effects of icosapent ethyl as an adjunct to statin therapy on plaque characteristics in a high cardiovascular-risk population with persistent high triglyceride levels. Patients underwent interim scans at 9 months and are currently being followed for an additional 9 months with MDCT. Final results from this study are anticipated in early 2020.

    Arterial plaque and coronary atherosclerosis are key factors leading to significant increases in the probability of acute obstructions and angina or other coronary artery disease signs and symptoms. 

All of the analyses highlighted above were funded by Amarin.

A replay of the webcast will be available for two weeks following the webcast. To hear a replay of the webcast, dial 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A replay of the webcast is also be available through the company's website, Amarincorp.com, in the Investor section. For both dial-in numbers please use conference ID 55923.

About Amarin
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.

About REDUCE-IT®
REDUCE-IT, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the cardioprotective effect of icosapent ethyl, a unique prescription therapy, as an add-on to statins in patients with high cardiovascular risk. As defined in the published results of the study, the high cardiovascular risk patients, despite stable statin therapy, had elevated triglyceride levels (lower enrollment target of TG >135 mg/dL). As per the study’s design, approximately 71% of the enrolled patients had established cardiovascular disease and the other patients were diagnosed, as per trial enrollment requirements, as having diabetes and other cardiovascular risk factors.

More information on the REDUCE-IT study results can be found at www.amarincorp.com.