Omega-3 acid ethyl esters

Omega-3 acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester and docosahexaenoic acid-ethyl ester that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia, and outside the US, in combination with other drugs to prevent heart attacks. This was the first class of fish oil-based drug to be approved for use as a drug. The first approvals came in Europe in 2001 and the first approval in the US came in 2004. These fish oil drugs are similar to fish oil dietary supplements but the ingredients are better controlled and have been tested in clinical trials.

Omega-3 acid ethyl esters are used in addition to changes in diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia.

In the European markets and other major markets outside the US, omega-3 acid ethyl esters are indicated for hypertriglyceridemia as a monotherapy, or in combination with a statin for patients with mixed dyslipidemia and as secondary prevention after heart attack in addition to other standard therapy (e.g. statins, anticoagulants, beta-blockers, and ACE-I).

Intake of large doses (2.0 to 4.0 g/day) of long-chain omega-3 fatty acids as prescription drugs or dietary supplements are generally required to achieve significant (> 15%) lowering of triglycerides, and at those doses the effects can be significant (from 20% to 35% and even up to 45% in individuals with levels greater that 500 mg/dL). It appears that both eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) lower triglycerides, but DHA appears to raise LDL-C ("bad cholesterol") more than EPA, while DHA raises HDL-C ("good cholesterol") while EPA does not.

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