Analysis results show taking iscosapent ethyl reduces the potential for CV death, coronary revascularization, hospitalization for unstable angina, myocardial infarction, and stroke by 35%.
Amarin Corporation has announced a data analysis from the REDUCE-IT study, which further strengthens the evidence of benefits of icosapent ethyl in adults who are at the highest risk of suffering from a potentially fatal or non-fatal cardiovascular (CV) event.
The new findings were published in the Journal of the American College of Cardiology, and the study was led by Deepak Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at the Brigham and Women’s Hospital at Harvard Medical School in Boston, Massachusetts.
“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,” Bhatt said in a statement.
“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,” he said.
Investigators identified individuals who had experienced a prior myocardial infarction (MI), or a heart attack, and were at an increased risk of another serious CV event without further intervention.
The REDUCE-IT Prior MI sub-analysis included 3693 individuals who had a prior MI within a median of 4.8 years before randomization. The baseline characteristics were similar among those randomized to icosapent ethyl and the placebo.
Investigators found that icosapent ethyl significantly reduced the primary composite endpoint by approximately 26%, which equated to an absolute risk reduction of approximately 5.9%.
The total events were significantly reduced by approximately 35% with icosapent ethyl in individuals with prior MI who are at elevated risk of another major event.
Additionally, icosapent ethyl led to an approximately 29% reduction in the key secondary composite endpoint of CV death, non-fatal MI, or non-fatal stroke. The rates of sudden cardiac death and cardiac arrest also showed a 40% and 56% relative risk reduction, respectively.
The safety of icosapent ethyl was consistent with the main study findings, with increased rates of atrial fibrillation and minor bleeding. However, there were no significant increases of major bleeding.
The data was included in both prespecified and post-hoc analysis. The landmark REDUCE-IT study findings were published in the New England Journal of Medicine in 2019 and included 8179 individuals for a median of 4.9 years, who were required to be treated with statins and other standard-of-care therapies.
All individuals in the study had controlled low-density lipoprotein cholesterol, elevated triglyceride levels, and other either established cardiovascular disease or diabetes with other CV risk factors.
“These and prior findings with icosapent ethyl are in stark contrast to clinical trial results and updates for other classes of therapy, particularly widely used fibrates, once thought to have the potential to reduce cardiovascular risk but which are now known to not adequately serve cardiovascular patients who are on statin therapy,” Karim Mikhail president and CEO of Amarin, said in the statement.
New analysis reveals icosapent ethyl significantly reduces risk of major cardiovascular events in patients with prior myocardial infarction (heart attack). Amarin. News release. May 3, 2022. Accessed May 3, 2022. https://investor.amarincorp.com/news-releases/news-release-details/new-analysis-reveals-icosapent-ethyl-significantly-reduces-risk