Developing Topics

Background: The omega-3 fatty acid eicosapentaenoic acid (EPA) has positive benefits for cardiovascular risk, reducing inflammation and improving endothelial function. Evidence suggests that Icosapent ethyl, a purified form of EPA, can improve cardiovascular outcomes in at-risk patients. Veterans are at higher risk for vascular dysfunction, a risk factor of Alzheimer's disease (AD), thus improving vascular health may be pivotal for delaying or preventing AD among Veterans.

Method: Cognitively healthy VA-eligible Veterans at William S. Middleton Memorial Veteran's Hospital in Madison, Wisconsin ages 50 through 75 were invited to enroll into an 18-month randomized, placebo-controlled, double-blind, parallel-group clinical trial which assessed the efficacy of Vascepa® IPE. 206 Veterans were screened for exclusion criteria, leading to the randomization of 131 Veterans to either the placebo or 4mg daily IPE. Triglyceride, low-density lipoprotein (LDL) cholesterol, and blood pressure were collected at baseline, 9-months, and 18-months. New adverse events were self-reported at all study visits. Lipid levels, blood pressure, and new adverse events were analyzed to determine any differences between Veterans receiving the study treatment or placebo.

Result: Our preliminary analysis indicated no differences for triglycerides, systolic and diastolic blood pressures, and LDL cholesterol between treatment and placebo at baseline (p-value range: 0.552-0.880). Cohen's d values for these ranged from 0.026-0.108 at baseline. Individuals in the placebo group reported more new adverse events than treatment group (Fisher test = 0.007). Analyses examining if there is any significant change in lipids and blood pressure due to study drug over study duration will be presented at the conference.

Conclusion: Placebo and treatment groups were well balanced in relation to baseline health measures. Study drug was well tolerated. Analyses of study drug efficacy are ongoing.