New REDUCE-IT Analyses Show VASCEPA/VAZKEPA (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

-- Findings Presented on VASCEPA/VAZKEPA Utility in REDUCE-IT Patient Subgroups by Baseline High/Low Lp(a), LDL-C Levels --

-- Lp(a) Results Published Simultaneously in the Journal of the American College of Cardiology (JACC) –

DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted two data presentations at ACC.24 describing the effects of VASCEPA/VAZKEPA (icosapent ethyl) on reducing MACE (Major Adverse Cardiovascular Events) in patients with baseline high or low Lipoprotein(a) [Lp(a)] levels, as well as reducing the risk of cardiovascular (CV) events in patients irrespective of baseline LDL-C level. The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College of Cardiology (JACC).

“These new findings provide additional important evidence about the clinical utility of VASCEPA/VAZKEPA and further demonstrate its value in reducing cardiovascular events in at-risk patients in key subgroups,” said Nabil Abadir, MB. CH.B., Chief Medical Officer and Head of Global Medical Affairs, Amarin. “At Amarin, we’re focused on the continuous generation of science to further advance the medical community’s understanding of the role and value of VASCEPA/VAZKEPA in reducing cardiovascular events in at-risk patients globally, and we are proud to add to the body of research that further demonstrates our commitment to value creation.”

The subgroup analyses and their key findings are outlined below:

Icosapent Ethyl Reduces MACE in Patients with Elevated Triglycerides and High or Low Lipoprotein(a) Concentrations: A REDUCE-IT Subanalysis

High Lp(a) concentrations are associated with increased CV event risk, even when LDL-C levels are well-managed. There are no treatments currently approved to reduce residual CV risk on top of contemporary medical therapy in patients with high Lp(a) levels.

In this post hoc analysis of REDUCE-IT, the relationship between continuous baseline Lp(a) concentration and risk of MACE was analyzed in models that also accounted for baseline LDL-C, baseline triglycerides (TG), and double-blind treatment.

REDUCE-IT participants were randomized to receive either 2g twice daily of icosapent ethyl (IPE) or matching placebo and followed for a median 4.9 years. In this subanalysis, there were 7,026 REDUCE-IT patients with baseline Lp(a) data and a median Lp(a) value of 11.6 (Q1-Q3: 5.0-37.4) mg/dL. Results showed that baseline Lp(a) had a strong and significant relationship with MACE irrespective of baseline LDL-C, baseline TGs, and treatment assignment, and that the benefit of IPE was consistent across Lp(a) concentrations. Importantly, the treatment benefit of IPE was evident across subgroups with both high (≥50 mg/dL) and low (<50 mg/dL) Lp(a) concentrations. Specifically, for first MACE, the relative IPE treatment effects for Lp(a) ≥50 mg/dL and <50 mg/dL were HR 0.79 (95% CI 0.64-0.97; P=0.0248) and HR 0.75 (95% CI 0.66-0.84; P<0.0001), respectively. Absolute risk reductions at 5 years with IPE were 6.5% and 5.7% for Lp(a) ≥50 mg/dL and <50 mg/dL, respectively.¹