Taking a high dose of icosapent ethyl—a pure and stable prescription form of the omega-3 fatty acid known as EPA—significantly reduces the occurrence of first, subsequent and total ischemic events, including heart attacks, strokes and related deaths, among people at high cardiovascular risk despite already being on statin therapy, according to research presented at the American College of Cardiology’s 68th Annual Scientific Session.
Compared with placebo, icosapent ethyl cut the combined rate of first and subsequent cardiovascular deaths; nonfatal heart attacks or strokes, procedures for coronary artery disease such as stenting; or hospitalizations for unstable angina (the study’s primary endpoint); by 30 percent, demonstrating the drug may be more protective than previously reported.
Earlier analyses of the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT); which were primarily focused on the first occurrence of a major adverse cardiovascular event; found a 25 percent reduction. This latest analysis aimed to determine the extent to which the drug reduced; the total burden of (first and subsequent) cardiovascular events.
Interventional cardiovascular programs
“In looking at the totality of events—not just the first ones, but subsequent ones too; we see that the drug provides even greater reductions in ischemic events. By looking only at first events, we underestimate the true underlying treatment benefit offered,” said Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs; at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and the study’s lead author. “From a patient’s perspective certainly, and from a physician’s point of view; icosapent ethyl’s impact on total events is what matters most.”
Bhatt said that patients with high triglycerides who also have atherosclerosis or diabetes; are especially vulnerable to repeat cardiovascular complications; so finding ways to prevent subsequent events is important and potentially lifesaving. Over a median follow-up period of approximately five years; there were nearly 3,000 events; 1,606 first events and 1,303 subsequent events, which included 762 second events, 272 third events and 269 fourth or more events.
For patients taking icosapent ethyl, first events were reduce 25 percent; second events by 32 percent, third events by 31 percent and fourth or more events were cut nearly in half (48 percent). The drug also prevented 1 in 5 cardiovascular-related deaths, as previously reported.
Burden of medical care
“With this drug, we are not only preventing that first heart attack but potentially the second stroke and maybe that third fatal event,” Bhatt said. “Prevention of such subsequent cardiovascular events could improve patient outcomes and quality of life and may lower the total cost burden of medical care.”
REDUCE-IT include 8,179 patients with elevate cardiovascular risk; who were already being treating with statins. Patients with well-controlled LDL-cholesterol (>40 and ?100 mg/dL) and with elevated triglycerides (135 to 499 mg/dL) and other cardiovascular risk factors were enrolled at 473 sites in 11 countries between 2011 and 2016. About 70 percent of patients in the study had established cardiovascular disease and the rest had diabetes without known cardiovascular disease but with at least one additional cardiovascular risk factor. At baseline, median triglyceride levels were 216 mg/dL and median LDL-cholesterol was 75 mg/dL.