Vascepa’s ACS Advantage

Amarin’s fish oil-based Vascepa (icosapent ethyl, aka IPE) made its mark in 2018’s REDUCE-IT trial after achieving a 25% MACE reduction among high-risk statin users, and new post hoc analysis of the same data suggests that IPE might have an even greater benefit among patients who recently had acute coronary syndrome (ACS).

Researchers analyzed 840 REDUCE-IT participants (10.3% of total trial) who experienced ACS within 12 months of trial randomization, finding that most patients who received IPE treatments had better five-year outcomes than those who received a placebo, including:

  • 36% reduced incidence of the composite primary endpoint (CV death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina)
  • 44% fewer urgent or emergent revascularizations
  • 36% reduced incidence of the composite secondary outcomes (CV death, non-fatal MI, or non-fatal stroke)

Patients in the IPE group also enjoyed a 9.3% absolute risk reduction for experiencing a first composite primary event (18.7% vs. 28%) and had a “number needed to treat” to avoid a primary event of 11 patients. 

  • That appears to suggest that IPE treatment timing is crucial with ACS. IPE had a far lower absolute risk reduction and much higher number needed to treat (4.7% & 21) among 3,651 patients in the original REDUCE-IT trial who experienced ACS 12 months or more before randomization.

IPE treatments also showed a positive safety profile with recent ACS patients, matching the placebo group for patients with at least one treatment-emergent adverse event (78.8% vs. 76.7%), total bleeding (6.9% vs. 8.1%), and bleeding-related serious adverse events (1.6% vs. 3.2%), even among patients who received DAPT.

  • IPE’s bleeding risk advantages are notable given that ACS patients generally receive intensive antithrombotic therapy. However, like the original REDUCE-IT trial, IPE had higher treatment-related rates of AFib or flutter (7.4% vs. 2.9%).

The Takeaway

With two FDA clearances and 20 million prescriptions so far, IPE has achieved quite a bit, but it hasn’t yet reached what some viewed as its early potential — and even the REDUCE-IT trial has faced its share of criticism. This study might not drastically alleviate IPE’s headwinds, but it does provide solid evidence supporting initiating IPE “as soon as possible after ACS.”

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