New Analysis Reveals Icosapent Ethyl Significantly Reduces Risk of Major Cardiovascular Events in Patients with Prior Myocardial Infarction (Heart Attack)
The latest prespecified and post hoc sub-analysis of the landmark REDUCE-IT® study, published today in the Journal of the American College of Cardiology (JACC), demonstrated that VASCEPA® (icosapent ethyl) significantly reduces the total ischemic event risk of cardiovascular death, stroke, myocardial infarction (heart attack), coronary revascularization, or hospitalization for unstable angina by 35% in patients who had a prior heart attack.(1)
Icosapent ethyl also resulted in significant reductions of 34% in myocardial infarction, 30% in CV death, and a 20% lower rate of all-cause mortality.
Sudden cardiac death and cardiac arrest were also significantly reduced.
DUBLIN, Ireland and BRIDGEWATER, N.J., May 03, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the publication in the Journal of the American College of Cardiology (JACC) of a new REDUCE-IT® data analysis further strengthening evidence of the benefits of icosapent ethyl in adult patients most at risk of suffering from a potentially fatal or non-fatal cardiovascular (CV) event. This new sub-analysis was led by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.
The patients identified in the new REDUCE-IT sub-analysis had experienced a prior myocardial infarction (MI), commonly called a heart attack, and as previously demonstrated, are therefore at much higher risk of another serious CV event without further intervention.(1) Research has shown that people who have had a heart attack are up to 50% more likely to have another CV event or heart procedure within only one year.(2)
The REDUCE-IT Prior MI sub-analysis studied 3,693 patients (45.2% of initial REDUCE-IT study population) who had a prior MI within a median of 4.8 years before randomization. Baseline characteristics were similar among patients randomized to icosapent ethyl versus placebo. Icosapent ethyl significantly reduced the primary composite endpoint (first occurrence of CV death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina) by 26% (HR 0.74, 95% CI 0.65-0.85, P=0.00001), equating to an absolute risk reduction of 5.9%. Total events (first and subsequent events) were significantly reduced by 35% (RR 0.65, 95% CI 0.56-0.77, P=0.0000001) in patients with prior MI who are at high risk of another major event.(1)
Icosapent ethyl also led to a 29% reduction in the key secondary composite endpoint of CV death, non-fatal MI, or non-fatal stroke (equating to an absolute risk reduction of 4.7% (HR 0.71, 95% CI 0.61-0.84, P=0.00006)). Rates of sudden cardiac death and cardiac arrest were also significantly reduced, showing 40% relative risk reduction (P=0.02) and 56% relative risk reduction (P=0.02), respectively.(1)
The safety of icosapent ethyl among patients with prior MI was consistent with the main study findings in the entire population, with increased rates of atrial fibrillation and of minor bleeding, though no significant increase in major bleeding. These data included both prespecified and post hoc analyses. It Is important to note that the exploratory nature limited the post hoc analysis. REDUCE-IT was not powered for subgroup analyses and all P-values should be considered hypothesis generating.(1)
The landmark REDUCE-IT cardiovascular outcomes study, published in New England Journal of Medicine (NEJM) in 2019, enrolled 8,179 patients for a median of 4.9 years, who were required to be treated with statins and other standard of care therapies. All patients had controlled low-density lipoprotein cholesterol (LDL-C), elevated triglyceride levels, and either established CVD or diabetes with other cardiovascular risk factors. (11)
Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT and senior author of the REDUCE-IT Prior MI analyses, said: “The REDUCE-IT Prior MI analyses provide valuable new data on the use of icosapent ethyl in patients who have had previous heart attacks. Treatment decisions for heart attack patients are particularly important given their elevated risk for another serious and potentially fatal cardiovascular event. These results build upon the positive findings from the main REDUCE-IT analysis and further strengthen the case for eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl in appropriate high-risk patients, such as those with prior heart attacks.”
Cardiovascular disease (CVD) is the leading cause of death and economic burden in many countries and regions around the world, including in industrialized countries. In the U.S., for example, someone dies of a CVD every 36 seconds, on average.(3) The estimated economic burden from CVD in the U.S. is projected to exceed $1 trillion by 2035.(4) Europe’s single biggest killer, CVD, is responsible for more than 4 million(5) patient deaths each year in the WHO European Region and has an economic health burden of €210 billion.(6)
Multiple trials have shown that statin therapy delivers a significant risk reduction of 25% to 35%(7, 8, 9, 10) for CV events, but this leaves a residual risk, beyond LDL-C treatment, of 65% to 75%.(7, 8, 9, 10) The high level of remaining risk strongly suggests the need for additional cardioprotective measures to help patients avoid a potentially life-changing or lethal CVD event by reducing the underlying CV risk beyond LDL reduction.
The REDUCE-IT Prior MI subgroup analysis was funded by Amarin. Dr Bhatt receives research funding from Amarin that goes to Brigham and Women’s Hospital.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
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