New findings show Vascepa significantly reduces cardiovascular events in high-risk patients

Icosapent ethyl (Vascepa—Amarin) may be more effective in preventing ischemic events than previously reported. The drug significantly reduced not only first but subsequent cardiovascular events among high-risk patients already receiving statin therapy, according to results of REDUCE-IT, presented at the American College of Cardiology’s (ACC) 68th Annual Scientific Session.

Icosapent ethyl, a prescription drug containing a highly purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA), made waves in November 2018 when early results of REDUCE-IT (Reduction of Cardiovascular Events with EPA–Intervention Trial) showed that the medication lowered the risk of first-time cardiovascular events by 26% for statin-treated patients with or at high risk of developing cardiovascular disease.

The new findings of the trial, published online March 18 in the Journal of the American College of Cardiology, showed that the drug reduced the rate of total cardiovascular events—including first and subsequent cardiovascular deaths, nonfatal heart attacks or strokes, coronary revascularization, and hospitalization for unstable angina—by 30%.

“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,” said lead author Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, in a statement.

The trial randomized 8,179 statin-treated patients with triglycerides between 135 mg/dL and 500 mg/dL and LDL-cholesterol levels between 40 mg/dL and 100 mg/dL to either icosapent ethyl 4 g daily or placebo. Of these patients, 71% had a history of atherosclerosis, and 29% had a history of diabetes.

Throughout the trial period of 4.9 years, 2,909 cardiovascular events occurred within the study population, of which 1,606 were first events and 1,303 were subsequent events. Compared with placebo, the icosapent ethyl group experienced a 25% reduction of first events, 32% of second events, 31% of third events, and 48% of fourth or more events.

While some are skeptical of the drug’s protective effects, the promising results of the study have garnered plenty of buzz.

“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.”

The study reported that icosapent ethyl was “well tolerated … and indicative of a favorable risk–benefit profile.” While the icosapent ethyl group displayed an increased incidence of atrial fibrillation and serious bleeding compared with the placebo group, the researchers noted that the overall rates of these adverse effects were low and did not increase the risk of stroke.

Amarin, the maker of icosapent ethyl, funded this study and was involved in the study design, collection, analysis, and interpretation.