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

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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; P<0.0001) with a number needed to treat (NNT) of 39. IPE significantly reduced STEMI (HR=0.60; 95% CI 0.44, 0.81; P=0.0008) and NSTEMI (HR=0.73; 95% CI 0.60, 0.89; P=0.001). There were clinically important and statistically significant reductions in MI subtypes, including MI leading to cardiac arrest (HR=0.49; 95% CI 0.28, 0.87; P=0.01) and resuscitated MI (HR=0.34; 95% CI 0.15, 0.76; P=0.006). IPE also significantly reduced the overall burden of total (first and subsequent) STEMI (rate ratio [RR]=0.59; 95% CI 0.43, 0.80; P=0.0006) and total NSTEMI (RR=0.72; 95% CI 0.58, 0.88; P=0.002) versus placebo.

All analyses highlighted above were funded by Amarin. Dr. Bhatt received research funding paid to Brigham and Women’s Hospital from Amarin for his role as the Chair of REDUCE-IT.

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