Abstract Body (Do not enter title and authors here): BACKGROUND: REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) was a multinational, double-blind trial that randomized 8,179 statin-treated patients with controlled low-density lipoprotein cholesterol, elevated triglycerides, and cardiovascular (CV) risk, to icosapent ethyl (IPE) 4 g daily or placebo. Randomization was stratified by established CV history (70.7%), or diabetes and other risk factors (29.3%).
METHODS/RESULTS: We evaluated IPE in patients with CV history, further characterized as having a documented history of coronary artery disease (CAD), or not. Primary (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, hospitalization for unstable angina) and key secondary (CV death, nonfatal MI, nonfatal stroke) CV endpoints were evaluated. Of the 5,785 (70.7%) REDUCE-IT patients with established CV disease, 4,532 patients had a history of CAD (multi vessel CAD, prior MI, hospitalization for high-risk non-ST-segment elevation acute coronary syndrome) and 1,253 patients did not. IPE reduced primary and key secondary first and total (first plus recurrent) events in patients with and without a history of CAD. In patients with CAD, IPE demonstrated a 25% relative risk reduction in first (HR 0.75; 95% CI 0.66, 0.84; P<0.0001; NNT 17) and 32% reduction in total primary endpoint events (RR 0.68; 95% CI 0.59, 0.78; P<0.0001) compared with placebo (Figure 1A). In patients without CAD, IPE demonstrated a 34% relative risk reduction in first (HR 0.66; 95% CI 0.51, 0.85; P=0.0012; NNT 13) and 47% reduction in total primary endpoint events (RR 0.53; 95% CI 0.40, 0.70; P<0.0001) (Figure 1B). In patients with and without CAD, similar robust reductions were observed for key secondary endpoint events. CV risk reductions were generally consistent across subgroup analyses by CAD history. Safety findings in patients with or without CAD were generally consistent with the overall study findings and did not differ substantially in patients with or without CAD.
CONCLUSION: IPE demonstrated robust CV benefit in statin-treated patients with CV disease. Patients with and without CAD experienced large reductions in absolute and relative risk of CV events.