Amarin’s Vascepa Evaluated in High-Risk Patients With Recent ACS Event

March 17, 2023—Amarin Corporation plc, headquartered in Dublin, Ireland, and Bridgewater, New Jersey, recently announced that a new analysis from the REDUCE-IT study showed the effectiveness of Vascepa/Vazkepa (icosapent ethyl [IPE]) in patients with recent acute coronary syndrome (ACS; < 12 months before randomization).

The post hoc analysis showed that IPE substantially and significantly reduced the risk of first and total ischemic events by 37% and 36%, respectively, in patients with recent ACS without increasing bleeding, supporting early initiation of IPE after ACS.

The data were presented at ACC.23/WCC, the American College of Cardiology’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana.

According to Amarin, this post hoc ACS analysis of the landmark REDUCE-IT study compared 840 patients (10.3% of the total trial cohort) who experienced recent ACS—defined as myocardial infarction (MI) or unstable angina < 12 months before randomization—versus 3,651 patients with ACS ≥ 12 months before randomization. Investigators assessed the efficacy of Vascepa/Vazkepa on first and total primary event endpoints.

The company reported that the absolute risk reduction for first events with IPE treatment over 5 years for the primary composite endpoint was 9.3%, with a number needed to treat (NNT) of 11. The absolute risk reduction for first events with IPE treatment in patients with ACS ≥ 12 months was 4.7%, with an NNT of 21.

Additionally, Amarin noted that overall tolerability and adverse event patterns with IPE and placebo in patients with recent ACS were consistent with the full study. Bleeding event rates were no more frequent with IPE than placebo despite extensive use of dual antiplatelet therapy.

Limitations of the analysis findings include that REDUCE-IT was not powered for multiple subgroup analyses, and this was a post hoc–defined subset among post-ACS patients, advised the company.

“Patients who have experienced ACS are at very high risk of a recurrent event, which can be life-threatening, particularly in the weeks following the index event,” commented Philippe Gabriel Steg, MD, in the company’s press release. “These results demonstrate that the addition of IPE to the treatment regimen of patients who have experienced ACS within the last 12 months can substantially reduce their risk of another cardiovascular event (with an absolute risk reduction of 9.3%) and that the earlier a patient begins treatment with IPE after ACS, the greater the absolute risk reduction for those patients.” Dr. Steg is Chief of Cardiology at Hôpital Bichat, Greater Paris University Hospitals–AP-HP, and Professor at Université Paris-Cité in Paris, France.

Nabil Abadir, MBChB, Chief Medical Officer and Head of Global Medical Affairs at Amarin, added, “As we know, the REDUCE-IT trial demonstrated the clear risk reduction benefits of IPE in reducing ischemic events among patients at high risk for cardiovascular disease. [These] data not only underscore the benefit for patients at risk for a cardiovascular event within 12 months following ACS but also build on the consistency of data across subpopulations in REDUCE-IT, with demonstrated positive outcomes for patients, including those with prior MI, prior revascularization, prior peripheral arterial disease, and diabetes.”