15th Annual World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease :

Prescription Omega-3 Lowers High Triglycerides in Women with T2D

Presentation by Megan Montgomery, PhD, with commentary from Eliot Brinton, MD, and Marc Cornier, MD

A prescription form of omega 3, eicosapentaenoic acid (EPA), reduced serum triglyceride levels in women with type 2 diabetes (T2D) without increasing LDL-C,1 according to research presented at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease.

"This study proved a totally new class of drugs works," said Elliot Brinton, MD, FAHA, FNLA, president of the Utah Lipid Center in Salt Lake City, Utah, and “most lipidologists will not be surprised by these findings.”

“Yet, the findings lend credence to the practice of being aggressive about lipid-lowering,” Dr. Brinton told EndocrineWeb, and while treatment always must be individualized,''these findings do invite us to treat more aggressively."

A prescription level omega 3 EPA might reduce triglycerides more than statins alone.

Evaluating Addition of EPA in Patients with High Triglycerides

"Overall, in women with type 2 diabetes and high triglycerides, four grams of EPA when compared to placebo did produce a reduction in triglyceride levels and did not raise LDL-cholesterol," said Megan Montgomery, PhD, a medical science liaison at Amarin Pharma, which makes Vascepa who presented the findings on behalf of the study authors.

Vascepa is FDA-approved to reduced TG levels in those with severe hypertriglyceridemia of 500 mg/dL or higher. It is a purified form of fish oil that includes only EPA, but no docosahexaenoic acid.  

The researchers conducted a subanalysis of participants in the ANCHOR study, in which they analyzed the EPA, Vascepa, as an add-on therapy in patients treated with statins who had persistently high triglycerides of 200 mg/dL or higher but under 500 mg/dL.

In the ANCHOR protocol, patients receiving statin therapy also received EPA for 12 weeks. The patients studied were women, the majority of whom were Caucasian.

A Closer Look at the Subanalysis

The phase 3b, double-blind trial had a four to six-week lead in phase with lifestyle and statin stabilization, and a non-study medication washout period.1

In this ANCHOR subanalysis, the researchers looked at patients with baseline TG levels of 200 to 400 mg/dL who were then treated with EPA over 12 weeks. The results evaluated outcomes for women who received EPA daily as compared to a cohort who were given a placebo.

The researchers examined not only at TG levels but many other parameters, including atherogenic lipid levels, lipoprotein.fractions, apolipoprotein levels, and inflammatory markers.1

The patients' baseline LDL-C was 40-99 mg/dL on statins; 74 women were randomized to EPA, 72 were placed in the placebo group.1

Methodology for the EPA Subanalysis

The average age of patients in the ANCHOR study was 61 years old among those in the EPA group and 62 years old for the placebo cohort. The average body mass index (BMI) was 32 for the EPA-treated group, and 33 for the patients receiving placebo.  

Among the median percent change in atherosclerosis risk parameters were:1

  • 22% reduction in TG (P < 0.0001)
  • 7% reduction in LDL-C (nonsignificant)
  • 15% in Non-HDL (P < 0.001)
  • 13% in total cholesterol (P < 0.0001)
  • 22% in VLDL-C (P < 0.001)
  • 27% in VLDL-TG (P < 0.001)

Expert Clinical Perspective

''Basically, the results of this study offers support for well-known data that fish oil reduces triglycerides in patients with hypertriglyceridemia,'' said Marc Cornier, MD, FAHA, FTOS, an endocrinologist and a professor of medicine at the University of Colorado School of Medicine in Aurora.

"What these findings add is that there are other markers of cardiovascular risk that are improved when EPA is introduced to patients receiving statin therapy," Dr. Cornier told EndocrineWeb.

He added a crucial caveat: "We don't know if it actually improves outcomes for these women. Still, this research is important since data has found that hypertriglyceridemia is especially associated with cardiovascular risk in women and especially women with diabetes.

“Until outcomes data is available, it is impossible to say if these results should trigger a change in practice,” Dr. Cornier said.

Awaiting Findings of REDUCE-IT Trial

The outcomes research is underway with REDUCE-It (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial).2

The double-blind, placebo-controlled trial will address the question of whether adding EPA to statin-treated patients with persistently high TGs may reduce cardiovascular outcomes. 2There are 8,000 patients enrolled in REDUCE-It worldwide.

Patients in the treated group will receive four grams of EPA daily (taken in two-2 gram doses) and compared to a placebo cohort.

"The REDUCE-It trial will examine a long-standing scientific question in testing the effectiveness of {omega 3] EPA to reduce cardiovascular events in patients with elevated TG and residual cardiovascular risk despite statin therapy," said Dr. Briton on behalf of the study team.

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