Icosapent ethyl was associated with a more significant reduction in first, subsequent, and total ischemic events in patients at high cardiovascular risk who are taking statins than initially thought, results from a study presented at the American College of Cardiology Annual Scientific Session in New Orleans.
Researchers for this analysis of the previously reported results of the REDUCE-IT trial, which included 8,179 patients randomly assigned to icosapent ethyl 4 g daily or to placebo in patients with established cardiovascular disease (about 70% of enrollees), diabetes, elevated triglycerides and elevated LDL-C levels, focused specifically on the effect of the therapy on first and other events. The research team led by Deepak Bhatt, MD, of MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, used multiple validated statistical models (negative binomial regression, Andersen-Gill, Wei-Lin-Weissfeld with Li and Lagakos modification, and joint-frailty) to examine the different study categories of events. Patients were followed for a media follow-up of 4.9 years.
Even More Efficacious
The study results showed a significant decrease in the total number of endpoint events (61 vs. 89 per 1,000 patient years for icosapent ethyl compared to placebo, respectively; RR=0.70; 95% CI, 0.62 to 0.78; P<0.0001). The results also showed a significant decrease in the key secondary endpoints compared to placebo (P=0.0000006) at five years. Icosapent ethyl also reduced each individual component of the primary endpoint, as well as key secondary endpoint events (32 vs. 44 per 1,000 patient years for icosapent ethyl compared to placebo, respectively; RR=0.70; 95% CI, 0.63 to 0.82; P<0.0001).
The analysis identified 1,606 first events in the patient population (55%), and 1,303 subsequent events (45%). Patients taking icosapent ethyl saw a nearly 25% reduction in first events, a 32% reduction in second events, a 31% reduction in third events, and almost half as many (48%) fourth or more events, according to the analysis.
“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, Dr. Bhatt said in a press release. “By looking only at first events, we underestimate the true underlying treatment benefit offered. 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.”
“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.”
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