VITAL and REDUCE-IT: positive results and presentations around omega-3 for heart health

29 January 2019
Omega-3 for heart health

Vitamin D and Omega-3 TriaL (VITAL Study):

VITAL investigated whether taking daily vitamin D3 and/or EPA+DHA (omega-3-acid ethyl esters) reduces the risk of major cardiovascular disease (CVD) events. These events were specifically defined as the composite of myocardial infarction (MI), stroke and CVD death. VITAL also looked at total invasive cancer in people who do not have a prior history of these illnesses. This is the first large-scale primary prevention trial — subjects included 25,871 men and women — looking at heart disease as an outcome.
For VITAL, omega-3s demonstrated no benefit for cancer outcomes compared to placebo and did not achieve the trial’s primary outcome of significantly reducing major CVD events. However, the following results were statistically significant, providing long-awaited evidence that omega-3s do provide benefits for primary prevention:
•    Total MI: 28% risk reduction (omega-3s: 145 events vs placebo: 200 events)
•    Total CHD: 17% risk reduction (omega-3s: 308 events vs placebo: 370 events)
•    Fatal MI: 50% risk reduction (omega-3s: 13 events vs placebo: 26 events)

Reduction of Cardiovascular Events With EPA – Intervention Trial (REDUCE-IT Study):

Amarin's Vascepa reduced major adverse cardiovascular events by 25% in a large-scale trial.
REDUCE-IT evaluated in 8,171 men and women whether EPA (icosapent ethyl), combined with a statin therapy, is superior to statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.
The following results from REDUCE-IT were statistically significant when the treatment group was compared to placebo:
•    Primary Endpoint Composite of the first occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization: 25% risk reduction (as previously reported)
•    Key Secondary Composite of CV death, MI, or stroke: 26% risk reduction
•    Cardiovascular Death or Nonfatal Myocardial Infarction: 25% risk reduction
•    Fatal or Nonfatal Myocardial Infarction: 31% risk reduction
•    Urgent or Emergent Revascularization: 35% risk reduction
•    Cardiovascular Death: 20% risk reduction
•    Hospitalization or Unstable Angina: 32% risk reduction
•    Fatal or Nonfatal Stroke: 28% risk reduction
•    Total Mortality, Nonfatal Myocardial Infarction or Nonfatal Stroke: 23% risk reduction

N Engl J Med 2019; 380:11-22. DOI: 10.1056/NEJMoa1812792.
N Engl J Med 2019; 380:91-93. DOI: 10.1056/NEJMe1814933.
N Engl J Med 2019; 380:23-32. DOI: 10.1056/NEJMoa1811403.
N Engl J Med 2019; 380:11-22. DOI: 10.1056/NEJMoa1812792.