6/29/23, 1:09 AM REDUCE-IT Pathway Feedback Search Clinical Topics Home Studies REDUCE IT REDUCE IT Disease Disease Dyslipidemia Hypertriglyceridemia Trial question What is the role of icosapent ethyl in patients with elevated triglyceride levels despite statins? Study design Multi-center Double blinded RCT Population Characteristics of study participants 29.0% female N = 8179 71.0% male 8179 patients (2357 female, 5822 male) Inclusion criteria: patients with elevated triglyceride levels despite the use of statins Key exclusion criteria: severe HF, active severe liver disease, history of acute or chronic pancreatitis, a planned coronary intervention or surgery, a glycated Hgb level > 10.0% Interventions N=4089 icosapent ethyl (2 g BID with food) N=4090 placebo (mineral oil BID) Primary outcome Major adverse cardiovascular events 22.0 % 22 https://web.pathway.md/studies/rec3pKWLW7X9jdi1e 1/2 6/29/23, 1:09 AM REDUCE-IT Pathway 17.2 16.5 % 11.0 % Significant decrease 5.5 % NNT = 21 0.0 % Icosapent ethyl Placebo Significant decrease in major adverse cardiovascular events (17.2% vs. 22%; HR 0.75, 95% CI 0.68 to 0.83) Secondary outcomes Significant decrease in CV death, nonfatal MI or nonfatal CVA (11.2% vs. 14.8%; HR 0.74, 95% CI 0.65 to 0.83) Significant decrease in cardiovascular death (4.3% vs. 5.2%; HR 0.8, 95% CI 0.66 to 0.98) No significant difference in death from any cause (6.7% vs. 7.6%; HR 0.87, 95% CI 0.74 to 1.02) Safety outcomes No significant differences in serious adverse bleeding events (2.7% vs. 2.1%, p=0.06) and serious adverse event, pneumonia (2.6% vs. 2.9%, p=0.42). Significant differences in a larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for AF or flutter (3.1% vs. 2.1%, p = 0.004). Conclusion In patients with elevated triglyceride levels despite the use of statins, icosapent ethyl was superior to placebo with respect to major adverse cardiovascular events. Reference Bhatt DL, Steg PG, Miller M et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. Open reference URL https://web.pathway.md/studies/rec3pKWLW7X9jdi1e 2/2