Epanova (omega-3-carboxylic acids)

Epanova is an FDA approved prescription medication used alongside a low fat and low cholesterol diet that lowers high triglyceride (fat) levels in adults.^[1] Epanova is the third prescription formulation of omega-3 polyunsaturated fatty acid approved in the United States but the first in free fatty acid form.^[2] It is derived from fish oil and an ultra pure mixture of the free fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The drug contains a concentration of DHA at 15-25 % and a concentration of EPA at 50-60%. The active ingredient of Epanova is a mixture of these free fatty acids derived from crude marine fish oil – a natural occurring substance.

Compared to other prescription omega-3s medications, Epanova has a dosing option as few as two capsules once a day.^[3] AstraZeneca, the company that developed Epanova, is commercializing the drug in the United States as a prescription monotherapy for patients with severe hypertriglyceridemia, and researching the safety and efficacy of combination therapy using Epanova and statins for patients with mixed dyslipidemia.^[1]

Medical Uses

Epanova has been shown to be effective in treating hypertriglyceridemia. Approximately 4 million American adults have hypertriglyceridemia, a condition where fat accumulates in the blood.^[4] More specifically, these patients have high levels of triglycerides, fats carried in the blood with lipoproteins, above 200 mg/dL leading to an increased risk of cardiovascular disease. The disease stems from both genetic and environmental factors including obesity, high-caloric diet and a sedentary lifestyle. The prevalence of hypertriglyceridemia is rapidly increasing across the United States and throughout the world. A National Health and Nutrition Examination Survey suggests that the “percentage of patients with severe hypertriglyceridemia has risen sharply along with the dramatic increases in obesity.”

Clinical Trials

Epanova was FDA approved in May 2014 following successful clinical trials that illustrated the drug’s effectiveness in treating hypertriglyceridemia.^[5] Specifically, this approval was based on two pharmacokinetic and Phase 3 trials often referred as EVOLVE (Epanova for Lowering Very High triglycerides) and ESPRIT (Epanova combined with a Statin in Patients with Hypertriglyceridemia to Reduce Non-HDL Cholesterol ). These trials were conducted in 6–12 weeks in a randomized and controlled group setting with 399 participants for the EVOLVE trial and 647 participants for the ESPRIT trial to test the efficacy of the drug. Ultimately, the trials concluded that triglyceride levels were in fact lowered across the groups after taking Epanova.^[6]

Benefits

Epanova effectively reduces triglyceride levels in adult patients. Other benefits of Epanova include a more consistent absorption rate compared to similar drugs, and a lower dosage for full effects.^[4]

Side Effects

There are safety concerns to consider while using Epanova such as close monitoring in therapy, and special caution should be taken with patients with fish and shellfish allergies. In addition, Epanova have experienced prolonged bleeding time, diarrhea, nausea, abdominal pain, and or eructation (burping).^[7] There have also been cases of increased LDL cholesterol levels.^[8]

References