Omega-3 fatty acid yielded significant reductions in triglycerides

A 4-g daily formulation of omega-3 fatty acid AMR101 was linked to decreases in triglyceride levels of more than 20% compared with placebo, according to recent results.

The aim of the ANCHOR trial was to determine the efficacy of AMR101 (Amarin) in reducing triglyceride levels without increasing LDL cholesterol in 702 individuals with high triglycerides who had experience with background statin therapies, including simvastatin (Zocor, Merck), atorvastatin (Lipitor, Pfizer) or rosuvastatin (Crestor, AstraZeneca). High triglycerides were defined as 200 mg/dL to 500 mg/dL. Eligible participants had mixed dyslipidemia, and 73% were diabetic.

Four grams of AMR101 was associated with a 21.5% decrease in triglyceride levels (P<.0001). The 2-g formulation reduced triglycerides by 10.1% (P=.0005).

Both doses of the drug yielded decreases in LDL that met predetermined noninferiority criteria. Compared with placebo, a 6.2% decrease in LDL was observed from baseline among patients receiving the 4-g dose. Among patients receiving 2 g per day, LDL was reduced by 3.6% compared with placebo (P=.0867).

Secondary endpoint results indicated that, compared with placebo, non-HDL cholesterol decreased by 13.6% in the 4-g per day group (P<.0001) and by 5.5% in the 2-g per day group (P =.0054).

Adverse event profiles were similar between treatment and placebo groups, and no drug-related adverse events were reported.

The primary outcome measure was the percentage change in triglyceride levels from baseline among patients on the AMR101 compared with placebo after 12 weeks. The trial was also powered to demonstrate a lack of LDL-elevating effect of the study drug compared with placebo. Secondary endpoints included the difference in other lipid and biomarker levels between treatment and placebo groups.

Disclosure: The ANCHOR study received funding from Amarin Corp.

Follow EndocrineToday.com on Twitter.