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

ABSTRACT

BACKGROUND: Adult patients with severe hypertriglyceridemia (SHTG) are at increased risk of developing acute pancreatitis and cardiovascular disease. Omega-3 carboxylic acids (OM3-CA) are approved for treatment as an adjunct to diet to reduce triglyceride (TG) concentrations in patients with SHTG. OBJECTIVE: The aim of the study was to assess efficacy and safety of the intermediate dose of OM3-CA (2 g daily), compared with olive oil 2 g daily, in reducing serum TG and lipid concentrations in patients with SHTG. METHODS: A randomized, double-blind, olive oil-controlled, parallel-group trial involving 162 adults with qualifying serum TG concentrations of at least 500 mg/dL (5.65 mmol/L) and <2500 mg/dL (28.25 mmol/L; <2000 mg/dL [22.60 mmol/L] in Canada). The treatment period after randomization was 12 weeks. Blood samples for measurement of fasting serum lipid concentrations were taken at baseline, 6, 10, and 12 weeks. RESULTS: Treatment with OM3-CA 2 g daily led to a significant reduction in TG concentrations (median of differences, -14.2% [95% confidence interval -26.2%, -2.8%; P = .017]) and non-high-density lipoprotein cholesterol concentrations (median of differences, -9.0% [95% confidence interval -14.8%, -2.8%; adjusted P = .018]) from baseline to the Week 12 endpoint, when compared with olive oil 2 g daily. These treatment effects were more pronounced in patients with qualifying TG concentrations >885 mg/dL (10 mmol/L). CONCLUSION: An intermediate dose of OM3-CA (2 g daily) significantly lowers TG and non-high-density lipoprotein cholesterol concentrations in patients with SHTG and may benefit individuals at risk of acute pancreatitis and cardiovascular disease.