Adjunct to dietary therapy to reduce very high (≥500 mg/dL) triglyceride concentrations in adults. Efficacy in reducing risk of pancreatitis or risk of cardiovascular morbidity or mortality in these patients not established.
Has been used as monotherapy to reduce high (200–499 mg/dL) triglyceride concentrations† in adults. However, because most of these patients are expected to receive statins as initial therapy, some experts state that efficacy should be further evaluated in patients receiving concomitant statin therapy. Preliminary data indicate additive effects on reduction of triglyceride and VLDL-cholesterol concentrations when used with statins.
Treatment may result in increases in LDL- and non-HDL-cholesterol concentrations in some individuals.
Prevention of Cardiovascular Events
Marine- and plant-derived omega-3 fatty acids (i.e., EPA, DHA, α-linolenic acid) have been used for primary† or secondary prevention† of CHD. However, additional studies needed to confirm and further define the health benefits of omega-3 fatty acids for such use. (See Prevention of Cardiovascular Events under Dosage and Administration.)
Dosage and Administration
General
Patients should be placed on a standard cholesterol-lowering diet before initiation of omega-3-acid ethyl esters therapy and should remain on this diet during treatment with the drug.
Administration
Oral Administration
Administered with meals in clinical studies.
Dosage
Each 1-g capsule contains ≥900 mg of the ethyl esters of omega-3 fatty acids (approximately 465 mg from ethyl esters of EPA and 375 mg from ethyl esters of DHA).
Adults
Dyslipidemias
Hypertriglyceridemia
Oral
Patients with very high (≥500 mg/dL) triglyceride concentrations: 4 g daily administered as a single dose or in 2 equally divided doses. Discontinue if adequate response not achieved after 2 months of therapy.
Prevention of Cardiovascular Events
Oral
AHA suggests incorporating omega-3 fatty acids in diet, although benefit in reducing CHD risk or total mortality not established. For primary prevention†, AHA suggests consumption of a variety of fish (preferably fatty fish such as herring, mackerel, salmon, sardines, or tuna) at least twice weekly and inclusion of oils and foods rich in α-linolenic acid (e.g., canola/flaxseed/soybean oils, flaxseeds, English walnuts) in diet. For secondary prevention†, AHA suggests consumption of approximately 1 g of a combination of EPA and DHA daily, preferably through dietary means (i.e., consumption of fatty fish); if intake cannot be achieved with diet alone, may consider supplements, but only in consultation with a clinician.
National Cholesterol Education Program (NCEP) expert panel has not recommended specific amount of omega-3 fatty acids for daily intake but does support AHA's recommendation to include fish in diet. Higher dietary intakes (1–2 g daily) identified by NCEP expert panel as an option for secondary prevention, but more definitive clinical trials required before such high dosages can be strongly recommended for either primary or secondary prevention.
Special Populations
No special population recommendations at this time.
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