HLS Therapeutics Inc. highlighted two data presentations at the 73rd Annual Scientific Sessions of the American College of Cardiology (ACC.24) describing the effects of VASCEPA (icosapent ethyl) on reducing Major Adverse Cardiovascular Events (MACE) 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 in the Journal of the American College of Cardology (JACC). 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.

These data are important and show that among adults with increased CV risk and elevated TGs, icosapent ethyl clearly reduced the rate of CV outcomes irrespective of baseline LDL-C. All analyses highlighted above were funded by Amarin. Dr. Deepak L. Bhatt served as the principal investigator for REDUCE-IT and his institution received research funding from Amarin.