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Clinical Summary

Omega-3 drug reduces ischemic events among statin-treated patients

Takeaway

  • An omega-3 drug reduces ischemic events among patients taking statins and who have well-controlled low-density lipoprotein cholesterol and existing cardiovascular (CV) risk factors.
  • Treating 1000 patients could prevent 159 events each year.
  • Results are from planned analysis of Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) of icosapent ethyl (IE; Vascepa), a derivative of the omega-3 fatty acid eicosapentaenoic acid.

Why this matters

  • This drug is already used to lower high triglycerides.

Study design

  • REDUCE-IT data for 8179 patients taking IE 4 g/day or placebo followed for a median 4.9 years.
  • Primary composite endpoint: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina.
  • Secondary composite endpoint: cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
  • Funding: Amarin Pharma, which markets Vascepa.

Key results

  • Overall, IE was associated with fewer primary endpoint events vs placebo:
    • 61 vs 89 per 1000 patient years;
    • Rate ratio, 0.70 (95% CI, 0.62-0.78; P<.0001).
  • Similar reductions for secondary endpoint events.

Limitations

  • Exploratory (but prespecified) analysis, used 1 post hoc method of several applied.

References


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