Amarin’s Vascepa Data From REDUCE-IT PRIOR MI Presented at ESC

August 26, 2021—Amarin Corporation plc announced the presentation of new data on Vascepa/Vazkepa (icosapent ethyl) in patients with previous myocardial infarction (MI) who are at risk for major adverse cardiovascular events. The data from REDUCE-IT PRIOR MI included both prespecified and post hoc analyses of study patients who had previous MI before trial randomization to determine if treatment with Vascepa reduced further ischemic events in those patients.

Principal investigator Deepak L. Bhatt, MD, is delivering “Reduction in Ischemic Events, Including Cardiovascular Mortality, with Icosapent Ethyl in Patients with Prior Myocardial Infarction: REDUCE-IT PRIOR MI,” as a late-breaking trial presentation at the European Society of Cardiology’s (ESC) Congress 2021 held virtually August 27-30, 2021.

The company advised that the presentation is available on-demand from August 23 through the completion of the ESC Congress. Additional REDUCE-IT and icosapent ethyl–related topics will be presented at the ESC Congress 2021 and can be found here, when registered for the ESC Congress.

Dr. Bhatt, who served as Global Principal Investigator and Steering Committee Chair for the REDUCE-IT study, discussed the findings in Amarin’s press release.

“The REDUCE-IT PRIOR MI analyses provide valuable data supporting an effective new approach to prevent ischemic events using prescription icosapent ethyl in patients who have had previous heart attacks,” commented Dr. Bhatt, who is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

Dr. Bhatt continued, “The benefits in these heart attack patients at-risk for another cardiovascular event are particularly important given these patients are at elevated risk for recurrent cardiovascular problems. These results further strengthen the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction by physicians caring for this high-risk population.”

As reported in the company’s announcement, the REDUCE-IT PRIOR MI investigators concluded, “Icosapent ethyl 4 g/day significantly reduced first and total primary endpoints of a five-point major adverse cardiovascular event (MACE), comprised of cardiovascular death, MI, stroke, coronary revascularization, and hospitalization for unstable angina by 26% and 35%, respectively, in patients with prior MI (P = .00001 and P = .0000001, respectively).”

The investigators further stated, “Icosapent ethyl led to generally robust reductions across the prespecified hierarchy of secondary endpoints, and in sudden cardiac death and cardiac arrest. The benefits of icosapent ethyl in patients with prior MI were consistent in those with or without a history or prior revascularization.”

According to Amarin, REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of Vascepa in adult patients with low-density lipoprotein cholesterol controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors, including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). The REDUCE-IT trial was conducted over 7 years and completed in 2018. The trial was composed of 8,179 patients at > 400 clinical sites in 11 countries with the largest number of sites located within the United States.

In November 2018, Amarin announced that the results from the REDUCE-IT trial were presented by Dr. Bhatt as a late-breaking clinical trial at the American Heart Association 2018 Scientific Sessions and published by Dr. Bhatt, et al in The New England Journal of Medicine (2019; 380:11-22).

Findings from the REDUCE-IT PCI analysis of the clinical impact of Vascepa in patients undergoing percutaneous coronary intervention (PCI) were presented by Benjamin E. Peterson, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

The REDUCE-IT PCI analysis evaluated 3,408 (41.7%) patients enrolled in REDUCE-IT who had undergone a previous PCI. These patients were randomized a median of 2.9 years after PCI. Baseline characteristics were similar among patients randomized to Vascepa versus placebo.

The post hoc exploratory analyses of the subgroup of 3,408 patients with a previous PCI showed that for the primary composite endpoint of five-point MACE, time to first event was significantly reduced with Vascepa versus placebo by 34% (P < .0001) and total (first and subsequent) events were also reduced by 39% (P < .0001). For the key secondary composite endpoint of three-point MACE, time to first event was reduced by 34% (P < .0001) in the subgroup of patients with a previous PCI.

Vascepa was launched in the United States in January 2020 after FDA approval for the treatment of high-risk patients with persistent cardiovascular risk after statin therapy. Vascepa was initially launched in the United States in 2013 based on the drug’s initial FDA-approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

In addition to the United States, Vascepa is approved and commercially available in Canada, Lebanon, and the United Arab Emirates.

In March 2021, the company received marketing authorization in the European Union for icosapent ethyl under the brand name Vazkepa for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, stated the company.