- 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
- 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.
- 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.
- Specific patient population; generalizability not known.