Rapid Review Alert May 10, 2013
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ADVANCES
 In EPA & DHA Research
Abstract (as published in NEJM)

Background
Trials have shown a beneficial effect of n−3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction.

Methods
In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n−3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes.

Results
Of the 12,513 patients enrolled, 6244 were randomly assigned to n−3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n−3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n−3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points.

Authors’ Conclusions
In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n−3 fatty acids did not reduce cardiovascular mortality and morbidity. 
Rapid Review Alert
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Omega-3s & Cardiovascular Risk Factors

Review of:
The Risk and Prevention Study Collaborative Group (2013). n–3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors. N Engl J Med 368:1800-1808. 


GOED Take-Away

  • The totality of the publicly available scientific evidence demonstrates a cardiovascular benefit of EPA and DHA in healthy populations, as well as in the majority of populations with pre-existing cardiovascular ailments. 
  • The list of long-chain omega-3 recommendations from professional organizations and government bodies continues to grow because the cardiovascular benefits associated with EPA and DHA are so compelling.

What Else Should You Know? 

  • For women only, the event rate for the primary outcome was significantly lower among those receiving omega-3 fatty acids compared to those receiving placebo.
  • The results of the study cannot be generalized to the general “healthy” population.
  • Compared to past studies demonstrating cardiovascular benefits of omega-3s, subjects in the current trial received better pharmaceutical treatment with: ACE inhibitors, angiotensin-receptor blockers, diuretic agents, calcium-channel blockers, beta-blockers, oral hypoglycemic drugs, insulin, statins and antiplatelet agents. Such treatment makes it less likely to be able to see a benefit of omega-3s. Note that the addition of another drug would unlikely yield an additional benefit without drastically increasing the power. 
  • While fish consumption was reported (43% consumed fish 1x/wk, 27% consumed fish 2x/wk), omega-3 blood levels were not. Among other things, this would have provided insight into compliance.  
  • Hospital admissions due to heart failure were significantly lower in the omega-3 group (96) versus placebo (142)
  • At the beginning of the trial, the primary efficacy end point was defined as the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. However, after a blinded assessment at 1 year showed an event rate that was lower than expected, the primary efficacy end point was revised as the composite of time to death from cardiovascular causes or hospital admission for cardiovascular causes.
  • 1 g EPA + DHA may have been too low a dose to demonstrate any significant cardiovascular benefit(s).   
  • There was a significant reduction in triglycerides in the omega-3 supplemented group compared to the placebo group, corroborating omega-3s ability to lower triglycerides. Of course, if the patients had atherosclerotic vascular disease then it may be a case of too little too late. 
  • In general, when testing the benefits of omega-3s, olive oil is considered a poor placebo.

Suggested Citation

Global Organization for EPA and DHA Omega-3s (2012). Omega-3s & Cardiovascular Risk Factors [Peer commentary on the paper “n–3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors” by The Risk and Prevention Study Collaborative Group (2013). N Engl J Med 368:1800-1808.].

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