|The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.|
CHICAGO — Among patients with hypertriglyceridemia, the risk for ischemic events (including cardiovascular death) is significantly lower with icosapent ethyl than placebo, according to late-breaking data presented at the 2018 Scientific Sessions of the American Heart Association, held November 10-12, 2018, in Chicago, Illinois and simultaneously published in the New England Journal of Medicine.1,2
Icosapent ethyl is a highly purified eicosapentaenoic acid ethyl ester indicated as adjunct therapy to lower triglyceride (TG) levels in adults with severe hypertriglyceridemia. Researchers led by Deepak L. Bhatt, MD, MPH, of Brigham and Women’s Hospital in Boston, Massachusetts, and colleagues, conducted REDUCE-IT (ClinicalTrials.gov Identifier: NCT01492361), a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other cardiovascular risk factors.
Included patients (N=8179) had been receiving statin therapy with a fasting TG level of 135mg to 499mg/dL (1.52–5.63mmol/L) and a low-density lipoprotein cholesterol (LDL-C) level of 41mg to 100mg/dL (1.06–2.59mmol/L). They were randomly assigned to receive either icosapent ethyl 2g twice daily or placebo; patients were followed for a median of 4.9 years.
The primary efficacy endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The major secondary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
The data showed the risk for the primary composite endpoint was significantly lowered by 25% among patients who received 2g of icosapent ethyl twice daily vs those who received placebo.
A primary composite outcome event occurred in 17.2% of the icosapent ethyl-treated patients vs 22.0% of those in the placebo group (hazard ratio [HR] 0.7; 95% CI, 0.68–0.83; P <0.001). Secondary outcome events occurred in 11.2% and 14.8% of patients in the icosapent ethyl and placebo arms, respectively (HR 0.74; 95% CI, 0.65–0.83; P <0.001).
Study authors also observed a significantly lower rate of additional ischemic endpoints (including the rate of cardiovascular death) in the icosapent ethyl group vs placebo (4.3% vs 5.2%, HR 0.80; 95% CI, 0.66–0.98; P =0.03).
Overall rates of adverse events were similar between the treatment groups. Rates of atrial fibrillation (5.3% vs 3.9%) and peripheral edema (6.5% vs 5.0%) were significantly higher in the icosapent ethyl group vs placebo. However, the rates of anemia (4.7% vs 5.8%) and gastrointestinal adverse events (33.0% vs 35.1%) were significantly lower in the icosapent ethyl group vs placebo. without any fatal bleeding events in either group.
“The results of REDUCE-IT stand apart from the negative findings of several contemporary trials of other agents that also lower triglyceride levels, including other n–3 fatty acids, extended-release niacin, fenofibrate, and cholesteryl ester transfer protein inhibitors,” the researchers concluded.
Disclosures: REDUCE-IT trial NCT01492361 was funded by Amarin Pharmaceuticals. Please refer to reference for full list of author disclosures.
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1. Bhatt BL, Steg PG, Miller M, et al. The primary results of the REDUCE-IT trial. Presented at: AHA 2018. November 10-12, 2018; Chicago, Illinois. Late-Breaking Session LBS.01.
2. Bhatt BL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia [published online November 10, 2018]. doi: 10.1056/NEJMoa1812792