Amarin’s Vascepa Evaluated in REDUCE-IT Prior MI Subanalysis

May 3, 2022—Amarin Corporation plc announced that a new subanalysis from the REDUCE-IT trial further strengthened evidence of the benefits of icosapent ethyl (Vascepa, in the United States; Vazkepa, in Europe) in adult patients most at risk of experiencing a potentially fatal or nonfatal cardiovascular (CV) event. The subanalysis data, which included both prespecified and post hoc analyses, were published by Prakriti Gaba, MD, et al, in the Journal of the American College of Cardiology.

The subanalysis was led by REDUCE-IT Principal Investigator Deepak L. Bhatt, MD. Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

The landmark REDUCE-IT CV outcomes study 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, elevated triglyceride levels, and either established CV disease or diabetes with other CV risk factors. The REDUCE-IT findings were presented 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).

According to Amarin, the patients identified in the REDUCE-IT subanalysis had experienced a previous myocardial infarction (MI). These patients, as previously demonstrated, are at much higher risk of another serious CV event without further intervention. Patients who have had previous MI have been shown to be up to 50% more likely to have another CV event or heart procedure within 1 year.

The “REDUCE-IT Prior MI” subanalysis studied 3,693 patients (45.2% of the initial REDUCE-IT study population) who had a previous MI within a median of 4.8 years before randomization. Baseline characteristics were similar among patients randomized to icosapent ethyl versus placebo.

The company advised 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.

Amarin reported the following findings from the REDUCE-IT Prior MI subanalysis:

• Icosapent ethyl significantly reduced the primary composite endpoint of first occurrence of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina by 26% (hazard ratio [HR], 0.74; 95% CI, 0.65-0.85; P = .00001), equating to an absolute risk reduction of 5.9%.
• Total events (first and subsequent events) were significantly reduced by 35% (relative risk [RR], 0.65; 95% CI, 0.56-0.77; P = .0000001) in patients with previous MI who are at high risk of another major event.
• Icosapent ethyl led to a 29% reduction in the key secondary composite endpoint of CV death, nonfatal MI, or nonfatal stroke (HR, 0.71; 95% CI, 0.61-0.84; P = .00006), equating to an absolute risk reduction of 4.7%.
• Rates of sudden cardiac death and cardiac arrest were also significantly reduced, showing 40% RR reduction (P = .02) and 56% RR reduction (P = .02), respectively.
• The safety of icosapent ethyl among patients with previous MI was consistent with the main study findings in the entire population, with increased rates of atrial fibrillation and minor bleeding but no significant increase in major bleeding.

Dr. Bhatt commented in Amarin’s press release, “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 CV event. These results build upon the positive findings from the main REDUCE-IT analysis and further strengthen the case for eicosapentaenoic acid in the form of prescription icosapent ethyl in appropriate high-risk patients, such as those with prior heart attacks.”

In March 2022, Amarin announced the publication of the REDUCE-IT Prior PCI post hoc subanalysis findings by Benjamin E. Peterson, MD, et al in Journal of the American Heart Association.