n-3 fatty acids in patients with multiple cardiovascular risk factors

The Risk and Prevention Study Collaborative Group. n-3 fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med. 2013;368(19):1800-1808.

Results from the Risk and Prevention Study showed no effect of omega-3 fatty acids on cardiovascular (CV) events and mortality among subjects at high CV risk.

A null result was seen for the primary endpoint, a composite of time to death from CV causes or hospital admission for CV causes, over 5 years of follow-up (median): the primary endpoint occurred among 11.7% of subjects in the omega-3 fatty acid group vs 11.9% in the placebo group (adjusted hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.88–1.08; P=0.58).

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Slide27 - Risk and Prevention Study No Effect of Omega-3  

 Null results were also seen for all secondary endpoints. Selected endpoints in the omega-3 fatty acid and placebo groups, respectively:

  • Death from CV cause: 2.3% vs 2.2%, HR, 1.03 (95% CI, 0.82–1.30); P=0.80
  • Hospitalization for CV cause: 9.9% vs 10.1%; HR, 0.98 (95% CI, 0.87–1.09); P=0.68
  • Death or nonfatal myocardial infarction (MI) or stroke: 7.8% vs 7.5%, HR, 1.03 (95% CI, 0.91–1.17); P=0.64
  • Death from CV cause or nonfatal MI or stroke: 4.6% vs 4.4%, HR, 1.05 (95% CI, 0.89–1.23); P=0.59
  • Death from coronary cause: 1.3% vs 1.2%, HR, 1.07 (95% CI, 0.78–1.46); P=0.66
  • Sudden death from cardiac cause: 0.8% vs 0.6%, HR, 1.22 (95% CI, 0.80–1.85); P=0.36

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Slide28 - Risk and Prevention Study Secondary Endpoints  

Subjects were randomized to 1 g omega-3 fatty acids/day (n=6,239) or placebo (olive oil; n=6,266) in this double-blind, placebo-controlled study. High CV risk was considered ≥1 of the following: multiple CV risk factors, evidence of atherosclerotic vascular disease, or any other condition putting the patient at high CV risk. Individuals with prior MI were excluded from the study.

The study's initial primary endpoint was cumulative rate of death, nonfatal MI, and nonfatal stroke. At 1 year, the event rate was lower than expected, and the primary endpoint was revised to a composite of death from CV causes or hospital admission for CV causes.

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Slide26 - Risk and Prevention Study Design  

 

The pharmacologic agents discussed are approved for use in the United States by the U.S. Food and Drug Administration (FDA) unless otherwise noted. Consult individual prescribing information for approved uses outside of the United States. 

May 2013 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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