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New REDUCE-IT® Data Show VASCEPA®/VAZKEPA® (icosapent ethyl) Reduced STEMI as Well as Other MI Subtypes

Published: 2022-08-26 12:19:00 ET
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-- Late-Breaking Data Show VASCEPA/VAZKEPA Significantly Reduced STEMI by 40% and NSTEMI by 27% in Pre-Specified, Post Hoc Analyses --

-- Data Presented During Late-Breaking Science Session at European Society of Cardiology (ESC) Congress 2022 in Barcelona --

DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 26, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that new REDUCE-IT data show that VASCEPA/VAZKEPA (icosapent ethyl) significantly reduced ST-segment elevation myocardial infarction (STEMI), non-ST segment elevated myocardial infarction (NSTEMI), and other MI subtypes in patients with established cardiovascular disease (CVD) or diabetes with risk factors.

The REDUCE-IT data presented today show STEMI was significantly reduced by 40% following treatment with icosapent ethyl (IPE) compared to placebo. IPE also significantly reduced NSTEMI by 27%. These data were presented today during a Late-Breaking Science Session at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain.

“This analysis of REDUCE-IT clearly shows that IPE 4 g/day as an adjunct to statin therapy in high-risk patients with residual hypertriglyceridemia provides a large and significant reduction in heart attacks,” said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of the REDUCE-IT trial. “Importantly, these new data show a significant reduction in the most important type of heart attack known as STEMI, as well as other MI subtypes.”

The REDUCE-IT study randomized 8,179 adult statin-treated patients with elevated triglycerides and either established CV disease or diabetes plus risk factors to IPE or placebo; median follow-up was 4.9 years. IPE treatment reduced the primary composite endpoint (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) and key secondary composite endpoint (CV death, nonfatal MI, or nonfatal stroke) endpoints 25% and 26%, respectively. Prespecified and post hoc analyses examined MI subtypes, which were independently adjudicated by a blinded Clinical Endpoint Committee.

In time to first event analyses, MI was significantly reduced with IPE treatment (HR=0.69; 95% CI 0.58, 0.81; P1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).

  • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
  • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
  • FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

    Europe

    For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    Forward-Looking StatementsThis press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning patients suffering from cardiovascular disease (CVD) and impacts on the risk of heart attack, stroke or other fatal or non-fatal cardiovascular events for patients who suffered a prior heart attack, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2021. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315IR@amarincorp.com

    Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028PR@amarincorp.com

    AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.

    1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart AssociationCirculation. 2020;141:e139-e596.2 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.6 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.7 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. Engl J Med. 2019;380:11-22.8 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802. 

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    Source: Amarin Corporation plc