6/28/23, 11:45 PM ORIGIN n-3 Fatty Acids Pathway Feedback Search Clinical Topics Home Studies ORIGIN n-3 Fatty Acids ORIGIN n-3 Fatty Acids Disease Diabetes mellitus type 2 Trial question What is the role of n-3 fatty acids in patients with or at risk for T2DM mellitus? Study design Multi-center Double blinded RCT Population Characteristics of study participants 35.0% female N = 12536 65.0% male 12536 patients (4386 female, 8150 male) Inclusion criteria: patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes Key exclusion criteria: unwilling to discontinue use of a nonstudy preparation of n-3 fatty acids, glycated Hgb level 9%, CABG within the previous 4 years with no intervening cardiovascular event, severe HF, or cancer that might affect survival Interventions N=6281 n-3 fatty acid supplementation (1 g capsule containing at least 900 mg of ethyl esters) N=6255 placebo (capsule containing 1 g of olive oil) Primary outcome https://web.pathway.md/studies/reczH9enCwL3F4epv 1/2 6/28/23, 11:45 PM ORIGIN n-3 Fatty Acids Pathway Cardiovascular death 9.3 % 9.3 9.1 7.0 % 4.7 % 2.3 % No significant difference 0.0 % N-3 fatty acid supplementation Placebo No significant difference in cardiovascular death (9.1% vs. 9.3%; HR 0.98, 95% CI 0.87 to 1.1) Secondary outcomes No significant difference in major vascular events (16.5% vs. 16.3%; HR 1.01, 95% CI 0.93 to 1.1) No significant difference in death from any cause (15.1% vs. 15.4%; HR 0.98, 95% CI 0.89 to 1.07) No significant difference in arrhythmic death (4.6% vs. 4.1%; HR 1.1, 95% CI 0.93 to 1.3) Safety outcomes No significant difference in adverse effects. Significant differences in triglycerides (-23.5 vs. -9.0 mg/dL, p < 0.001). Conclusion In patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes, n-3 fatty acid supplementation was not superior to placebo with respect to cardiovascular death. Reference ORIGIN Trial Investigators, Bosch J, Gerstein HC et al. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. Open reference URL https://web.pathway.md/studies/reczH9enCwL3F4epv 2/2