In high-risk patients taking icosapent ethyl, EPA levels linked to HF rates
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In patients from the REDUCE-IT trial assigned icosapent ethyl, those who achieved high or moderate levels of eicosapentaenoic acid had better HF outcomes compared with those who achieved low levels, researchers reported.
The REDUCE-IT trial had an overall population of 8,179 patients who had established CVD or risk factors, well-controlled LDL (41 mg/dL to 100 mg/dL) and elevated triglycerides (135 mg/dL to 499 mg/dL). For an analysis presented at the American College of Cardiology Scientific Session, the researchers compared HF outcomes in patients assigned icosapent ethyl (Vascepa, Amarin) 4 g daily during a median follow-up of 4.9 years. Patients were stratified into tertiles based on on-treatment serum eicosapentaenoic acid (EPA) levels.
“The REDUCE-IT HF analyses provide interesting data about a potential new approach to addressing HF, a condition that continues to challenge patients and cardiologists worldwide. The potential benefit of increased serum EPA levels in reducing the composite of cardiovascular death or new HF requiring hospitalization in at-risk patients is a novel finding for icosapent ethyl and requires further prospective validation. These results add to the growing body of knowledge regarding icosapent ethyl,” Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center, professor of medicine at Harvard Medical School, who presented the new findings, said in a press release.
According to the researchers, there was no difference between the icosapent ethyl and placebo groups for the prespecified tertiary endpoints of new HF (HR = 0.95; 95% CI, 0.77-1.17; P = .63) and new HF requiring hospitalization (HR = 0.97; 95% CI, 0.77-1.22; P = .78).
In post hoc analyses of patients in the icosapent ethyl group only, compared with the lowest on-treatment EPA tertile (median, 55 µg/mL), patients in the middle (median, 139 µg/mL) and upper (median, 215 µg/mL) tertiles had reduced risk for new HF (HR for middle vs. low = 0.55; 95% CI, 0.37-0.81; P = .003; HR for high vs. low = 0.41; 95% CI, 0.27-0.63; P < .0001) and new HF that required hospitalization (HR for middle vs. low = 0.47; 95% CI, 0.3-0.74; P = .0008; HR for high vs. low = 0.45; 95% CI, 0.29-0.7; P = .0005).
“Heart failure, in particular, devastates patients, their families and economies with significant direct costs and societal impact. We owe it to at-risk patients to analyze the data from our cardiovascular outcomes study and explore whether therapies such as icosapent ethyl might ease the burden,” Steven Ketchum, PhD, senior vice president, president of research and development and chief scientific officer of Amarin, said in the release.
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Bhatt DL, et al. Heart Failure and Cardiomyopathies: Clinical Trials. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).
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