Table 6.
Randomized Controlled Trials of free Omega-3 Carboxylic Acid (EPA and DHA) Supplementation in Primary and/or Secondary Prevention of CVD by Sex and Race
| Study Year |
# subjects Female/male |
Mean age Follow-up |
Race ethnicity | Characteristics (exposure) n-3 type and dosage Baseline TG and % reduction |
Endpoint | Outcome of the exposure or intervention |
|---|---|---|---|---|---|---|
| OMEMI 33 2021 All post-MI for 2-8 weeks |
1,027 patients 29% female |
Mean±SD age: 75±3.6 years (range 70-82 years) 2 year follow-up |
4 Centers in Norway White: 99.8% |
EPA: 930 mg DHA: 660 mg vs corn oil placebo Mean triglyceride: 111.4±61.9 mg/dL. |
Primary Endpoint Secondary endpoint: |
Composite of nonfatal MI, unscheduled revascularization, stroke, all-cause death, heart failure hospitalization 21.4% on n-3 PUFA vs 20.0% on placebo (HR, 1.08 [95% CI, 0.82–1.41]; P=0.60). Afib: 7.2% (28) on n-3 PUFA vs 4.0% (15) on placebo (1.84 [0.98–3.45]; P=0.06). |
| STRENGTH34 2020 55.9% with CVD; n= 7,316 70% with DM and either CVD or at least 1 additional risk factor |
13,078 35% women CVD group: n-3 = 3,638 Placebo: 3,678 |
Mean age 62.5±9 years Median follow-up: 42 months |
22 countries Black=345 *Other= 654 TG reduction: −19.0% vs −0.9%; net −18.1% for omega-3; Non-HDL: −6.1% vs −1.1%; net 5% for omega-3 |
Omega-3 carboxylic acid 4 g- EPA: 2,200 mg; DHA: 800 mg daily vs corn oil placebo -Primary outcome: cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization Primary prevention Secondary prevention -Secondary outcome of coronary events: cardiac death, MI, revasc and hospitalized unstable angina |
Total group Men n=8,510 Women n=4,563 Asian n=1355 n = 5,762 n=7,316 Secondary endpoint: Total group |
HR: 0.99; 95% CI, 0.90-1.09; P=0.84 HR: 1.01; 95% CI: 0.90-1.13 HR: 0.94; 95% CI: 0.78-1.14 HR: 0.72;95% CI: 0.54-0.96 HR: 1.16; 95% CI: 0.95-1.41 HR: 0.94; 95% CI: 0.84-1.05 HR: 0.85; 95% CI: 0.75-0.97, P=0.02 |
Other: American Indian or Alaskan Native, Native Hawaiian or Pacific Islander, multiple race or unknown
Abbreviations: Afib indicates atrial fibrillation; CI, confidence interval; CVD, cardiovascular disease; DHA, docosahexaenoic acid; DM, diabetes mellitus; EPA, eicosapentaenoic acid; g, gram; HR, hazard ratio; MI, myocardial infarction; n-3, omega-3; OMEMI, Omega-3 Fatty acids in Elderly with Myocardial Infarction; PUFA, polyunsaturated fatty acid; RR, relative risk; STRENGTH, Long-Term Outcomes Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia; TG, triglyceride.