Bhatt DL, et al. – Given that individuals with high triglyceride levels are at increased risk for ischemic events and icosapent ethyl (a highly purified eicosapentaenoic acid ethyl ester) can reduce these levels, experts assessed the potential impact of icosapent ethyl on ischemic events. According to findings, among those with high triglyceride levels, the risk of ischemic events—including cardiovascular death—was substantially lower among those who received 2 g of icosapent ethyl twice a day (BID) vs those who received placebo.

Methods

• This multicenter, randomized, double-blind, placebo-controlled trial included patients with cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135-499 mg/dL and a low-density lipoprotein cholesterol level of 41-100 mg/dL.
• Researchers randomized patients to receive icosapent ethyl 2 g BID or placebo.
• A composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina comprised the primary end point.
• A composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke comprised the key secondary end point.

Results

• Study participants included 8,179 patients who were followed for a median of 4.9 years.
• In 17.2% of the patients in the icosapent ethyl group, a primary end-point event occurred vs 22.0% of the patients in the placebo group (HR, 0.75; 95% CI, 0.68 to 0.83; P < 0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (HR, 0.74; 95% CI, 0.65 to 0.83; P < 0.001).
• In the icosapent ethyl group, the rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower vs the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%, respectively; HR, 0.80; 95% CI, 0.66 to 0.98; P=0.03).
• Findings suggested that a larger percentage of patients in the icosapent ethyl group were hospitalized for atrial fibrillation or flutter than in the placebo group (3.1% vs. 2.1%, respectively; P=0.004).
• They noted serious bleeding events in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).