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. 2022 May 28;17:100148. doi: 10.1016/j.ahjo.2022.100148

Table 2.

Overview of contemporary cardiovascular outcomes trials with omega-3 fatty acids.a, b, c, d

REDUCE-IT [17] STRENGTH [24] OMEMI [25] ASCEND [26] VITAL [27]
Intervention 2 g icosapent ethyl twice daily vs 2 g twice daily mineral oil placebo 4 g/day omega-3 carboxylic acids or 4 g/day corn oil placebo 1.8 g/day (930 mg EPA + 660 mg DHA) vs 1.8 g/day corn oil placebo 1 g/day (460 mg EPA + 380 mg DHA) or 1 g/day olive oil placebo 1 g/day (460 mg EPA + 380 mg DHA) or 1 g/day olive oil placebo
Total number of patients 8179 13,078 1027 15,480 25,871
Entry criteria
  • •

    TG 150–499 mg/dL

  • •

    LDL-C 41–100 mg/dL

  • •

    ≥45 years of age with established CV disease

OR
≥50 years of age with diabetes mellitus and ≥1 additional CV disease risk factor
  • •

    Stable statin
  • •

    TG 180–499 mg/dL

  • •

    LDL-C <100 mg/dL or on maximally tolerated statin

  • •

    HDL-C <42 mg/dL for men and <47 mg/dL for women

  • •

    Adult patients with established ASCVD

OR
Type 1 or 2 diabetes (≥40 years of age for men and ≥50 years of age for women) with ≥1 additional CV risk factor
OR
High-risk primary prevention patients (≥50 years of age for men and ≥60 years of age for women) with ≥1 additional CV risk factor
  • •

    Stable statin
  • •

    Patients hospitalized due to acute MI, 70–82 years of age
  • •

    Diabetes mellitus without evidence of CV disease

  • •

    ≥40 years of age
  • •

    Men ≥50 years of age and women ≥55 years of age
Patients with established CVD, % 70.7 55.9 100 – –
Concomitant statin, % 100 100 95.2 75.2 34.9
Median baseline metabolic parameters
TG, mg/dL 216 240 111.4a – –
LDL-C, mg/dL 75 75 76.1a – –
Median follow-up 4.9 years 42 months 24 months 7.4 years 5.3 years
Primary endpoint Composite of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina Composite of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina First major CV event, consisting of nonfatal MI, unscheduled revascularization, stroke, or all-cause deathb First serious vascular event (composite of nonfatal MI or stroke, transient ischemic attack, or vascular death excluding intracranial hemorrhage) Major CV events (composite of MI, stroke, and death from any CV cause)
Primary endpoint result, HR (95% CI) 0.75 (0.68–0.83; P < 0.001) 0.99 (0.90–1.09; P = 0.84) 1.07 (0.82–1.40; P = 0.62) 0.97 (0.87−1.08; P = 0.55)c 0.92 (0.80−1.06)
Components of the primary endpoint, HR (95% CI)
All-cause mortality – – 1.01 (0.54–1.88; P = 0.98) – –
CV death 0.80 (0.66–0.98) 1.09 (0.90–1.31; P = 0.37) – 0.81 (0.67−0.99)d 0.96 (0.76−1.21)
MI – – – – 0.72 (0.59−0.90)
Nonfatal MI 0.70 (0.59–0.82) 0.97 (0.81–1.17; P = 0.77) 1.14 (0.72–1.80; P = 0.57) 0.93 (0.76−1.14) –
Stroke – – 1.37 (0.65–2.88; P = 0.41) – 1.04 (0.83−1.31)
Nonfatal stroke 0.71 (0.54–0.94) 1.14 (0.90–1.45; P = 0.28) – 1.01 (0.84−1.22) –
Transient ischemic attack – – – 1.03 (0.84–1.26) –
Coronary revascularization 0.66 (0.58–0.76) 0.94 (0.83–1.08; P = 0.41) 0.66 (0.34–1.30; P = 0.23) – –
Hospitalization for unstable angina 0.68 (0.53–0.87) 0.84 (0.63–1.12; P = 0.23) – – –
Hospitalization for heart failure – – 1.19 (0.62–2.26; P = 0.61) – –
Secondary endpoint Composite of CV death, nonfatal MI, or nonfatal stroke Composite of CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina in patients with established CV disease at baseline New-onset atrial fibrillation Serious vascular event or revascularization Major CV events plus coronary revascularization
Secondary endpoint result, HR (95% CI) 0.74 (0.65–0.83; P < 0.001) 0.94 (0.84–1.05; P = 0.27) 1.84 (0.98–3.44; P = 0.056) 1.00 (0.91−1.09) 0.93 (0.82−1.04)
Median placebo-corrected percent change in metabolic parameters after 1 year
TG, mg/dL −20.1 −18 −13.2% – –
LDL-C, mg/dL −6.6 +3 −0.7% – –

ASCEND, A Study of Cardiovascular Events in Diabetes; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid; HDL-C, high-density lipoprotein cholesterol; HR, hazard ratio; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; OMEMI, Omega-3 Fatty acids in Elderly with Myocardial Infarction; qd, daily; REDUCE-IT, Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial; STRENGTH, Statin Residual Risk Reduction With Epanova in High CV Risk Patients With Hypertriglyceridemia; TG, triglyceride; VITAL, Vitamin D and Omega-3 Trial.

a

Mean.

b

Hospitalization for heart failure was added to the definition of major cardiovascular events.

c

Rate ratio.

d

Vascular death.