Amarin presents new REDUCE-IT analyses at ACC.24

Amarin highlighted two data presentations at ACC.24 describing the effects of VASCEPA(R)/VAZKEPA on reducing MACE, or Major Adverse Cardiovascular Events, in patients with baseline high or low Lipoprotein(a) levels, as well as reducing the risk of cardiovascular events in patients irrespective of baseline LDL-C level. The subgroup analyses and their key findings are outlined below: 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 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 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 and low Lp(a) concentrations. Specifically, for first MACE, the relative IPE treatment effects for Lp(a) greater than or equal to50 mg/dL and less than50 mg/dL were HR 0.79 and HR 0.75, respectively. Absolute risk reductions at 5 years with IPE were 6.5% and 5.7% for Lp(a) greater than or equal to50 mg/dL and less than50 mg/dL, respectively. Limitations include that participants in REDUCE-IT were not selected on the basis of their baseline Lp(a) concentration and that not all REDUCE-IT patients had available baseline Lp(a) data. In a post hoc analysis, investigators explored REDUCE-IT data to determine if IPE reduces CV outcomes among high-risk CV patients irrespective of baseline LDL-C. Patients were stratified by LDL-C less than55 vs greater than or equal to55 mg/dL. The primary outcome was a composite of CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. Among statin-treated REDUCE-IT patients with baseline LDL-C data, 1,058 had LDL-C less than55 mg/dL and 7,117 had LDL-C greater than or equal to55 mg/dL. The primary outcome rate among patients with LDL-C less than55 mg/dL was 16.2% in the IPE group and 22.8% in the placebo group, HR 0.66. Findings were consistent in the LDL-C greater than or equal to55 mg/dL subgroup, with rates of 17.4% in the IPE group and 21.9% in the placebo group, HR 0.76. No significant interaction by baseline LDL-C was observed. Limitations are that randomization was not stratified by baseline LDL-C, however, baseline characteristics were similar among the two baseline LDL-C subgroups. REDUCE-IT patients were on statin therapy, but with low rates or unavailability of other lipid therapies such as ezetimibe, proprotein convertase subtilisin-kexin type 9 inhibitors, or small interfering RNA therapies. All analyses highlighted above were funded by Amarin.