This article is part of MPR‘s coverage of the American Diabetes Association’s 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.

At the American Diabetes Association 77th Scientific Sessions in San Diego, CA, Amarin announced new data from ANCHOR study analyses evaluating Vascepa (icosapent ethyl) in statin-treated women with type 2 diabetes and persistent high triglycerides (TG).

The 12-week ANCHOR study evaluated the efficacy of Vascepa in adults at high-risk for cardiovascular disease with persistent high TG (≥200mg/dL and <500mg/dL) after stable stain therapy. The post-hoc analysis aimed to study the risks and benefits associated with Vascepa therapy specifically in women with diabetes and elevated TG.

In the post-hoc analysis of a subgroup of statin-treated women with persistent high TG and type 2 diabetes (n=146), treatment with Vascepa 4g daily lowered TG, other atherogenic lipid markers, and inflammatory markers, and significantly increased blood eicosapentaenoic acid (EPA) levels vs. placebo. These findings were consistent with the general ANCHOR study results.

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A separate ;in vitro mechanistic study found that EPA may be a new approach to lower blood vessel cell dysfunction. In the study, EPA was shown to have antioxidant properties different from docosahexaenoic acid (DHA) that helped maintain cellular functions within blood vessel cells under disease-like conditions. 

Amarin also presented an update on the REDUCE-IT cardiovascular outcomes study (n=8,175) that was initiated in 2011 to evaluate the effects of pure EPA prescription therapy or any TG-lowering therapy as an add-on to statins in patients with cardiovascular risk who have high TG (200–499mg/dL) despite stable statin therapy. The study reached the onset of ~80% of the target number of primary cardiovascular events and there are plans for a pre-specified interim efficacy analysis. The onset of the target final primary cardiovascular event is expected to be reached by the end of the year.

Vascepa, an ethyl ester of EPA, is currently indicated as adjunct to diet to lower TG levels in adults with severe hypertriglyceridemia. It is available in 0.5g and 1g strength soft gelatin capsules.

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