Physicians' Academy for Cardiovascular Education

Patients with severe hypertriglyceridemia benefit from omega-3 carboxylic acids 2 g/day

Omega-3 carboxylic acids in patients with severe hypertriglyceridemia: EVOLVE II, a randomized, placebo-controlled trial

Stroes ESG, Susekov AV, de Bruin TWA, et al. - J of Clin Lipidol 2017; printed online ahead of print

Background

Severe hypertriglyceridemia (SHTG) is characterized by a serum TG concentration ≥ 500 mg/dL (5.65 mmol/L), and is associated with a high risk of acute pancreatitis and CVD [1,2]. International guidelines state that the treatment goal is to minimize TG concentration in this condition, for example by administration of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) [3,4]. A new formulation of omega-3 carboxylic acids (OM3-CA), derived from fish oils and containing EPA and DHA, provides improved bioavailability compared with ethyl ester formulations, and is approved for treatment of SHTG with a daily dose of 2 g or 4 g as an adjunct to diet [5,6].

In this randomized, double-blind, phase 3 trial, the primary objectives were to assess the efficacy and safety of OM3-CA 2 g daily compared with olive oil 2 g daily in reducing serum TG and lipid concentrations over a 12-week treatment period. This study enrolled 162 patients with SHTG, including patients with qualifying TG concentrations > 885 mg/dL (10 mmol/L) and patients with Fredrickson Type V hyperlipidemia, a condition which is biochemically defined as TG:VLDL-c ratio ≥ 6.

The secondary objectives of the study were to determine the effects of OM3-CA 2 g daily, compared with olive oil 2 g daily, on non-HDL-c and HDL-c concentrations over a 12-week treatment period, whereas the effects of the study medication on LDL-c and LVDL-c comprised the exploratory objectives of this investigation.

Eligible participants had a BMI ≥ 20 kg/m2, untreated dyslipidemia or dyslipidemia treated with lipid-lowering therapy, and qualifying serum TG concentrations of ≥ 500 mg/dL and < 2500 mg/dL (< 2000 mg/dL in Canada).

Main results

Conclusion

Patients with SHTG treated with OM3-CA 2 g daily had a statistically significant reduction in TG and non-HDL-c concentrations compared with those treated with olive oil 2 g daily. Patients with qualifying TG concentrations > 885 mg/dL (> 10 mmol/L) showed a larger TG reduction than those in the overall study population. These findings suggest that OM3-CA may be useful for the prevention of acute pancreatitis and CVD in these patients.

References

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Find this article online at J Clin Lipidol 2017