Omega-3 surprise: CVD risk is reduced in highly anticipated trial results

  • Amarin Corporation

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • With the omega-3 drug Vascepa (Amarin Corporation), risk for major adverse cardiovascular events (MACE) dropped by 25% among patients with elevated cardiovascular disease (CVD) risk who were taking statins.

Why this matters

Key results

  • Median follow-up, 4.9 years.
  • MACE risk reduced by about 25% in the intention-to-treat group (P<.001 vs placebo>
  • In a statement, the company says there were “robust demonstrations of efficacy across multiple secondary endpoints.”
  • Company says drug was well-tolerated, with no safety signals beyond existing experience with omega-3s.
  • Similar adverse event rates between treatment and placebo; most common was arthralgia (2.3% treatment vs 1.0% placebo).
  • Company will provide more details at American Heart Association meeting in November 2018.

Study design

  • Enrollees in  REDUCE-IT trial had low-density lipoprotein 41-100 mg/dL, were taking statins, had CVD risk factors (increased triglycerides plus either CVD or diabetes and at least 1 more risk factor).
  • Drug dose: 4 g/day.
  • Funding: Amarin.

Limitations

  • Specific patient population; generalizability not known.

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