New REDUCE-IT Analyses Show VASCEPA/VAZKEPA (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups - Seite 2

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 this analysis, IPE showed a clear clinical benefit for patients with both high and low Lp(a) levels. IPE provided a relative risk reduction of 21% among patients with an Lp(a) level of ≥50 mg/dL and 25% for those patients with an Lp(a) level of <50 mg/dL,” said Dr. Michael Szarek, professor, Division of Cardiology, University of Colorado School of Medicine and a faculty member at CPC Clinical Research. “These findings are important, as high baseline Lp(a) concentrations are a predictor for MACE, and this analysis reinforces IPE’s clinical benefit in these at-risk patient sub-populations.”

The analysis and its findings were published simultaneously online in JACC.

Efficacy of Icosapent Ethyl for Reducing Cardiovascular Outcomes by Baseline Low Density Lipoprotein Cholesterol Level

Elevated low-density lipoprotein cholesterol (LDL-C) is a well-established major CV risk factor supported by clinical evidence showing decreased atherosclerotic disease events when LDL-C is therapeutically lowered. Recent international guidelines recommend lowering LDL-C to <55 mg/dL in those patients who are at very high risk for a future CV event.

In this 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 <55 vs ≥55 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 (12.9%) had LDL-C <55 mg/dL and 7,117 (87.1 %) had LDL-C ≥55 mg/dL. The primary outcome rate among patients with LDL-C <55 mg/dL was 16.2% in the IPE group and 22.8% in the placebo group, HR 0.66 (95% CI 0.50-0.87; P=0.003). Findings were consistent in the LDL-C ≥55 mg/dL subgroup, with rates of 17.4% in the IPE group and 21.9% in the placebo group, HR 0.76 (95% CI 0.69-0.85; P<0.0001). No significant interaction by baseline LDL-C was observed.