Lovaza is a brand name prescription drug. The capsule developed by GlaxoSmithKline contains esterified fish oils and is approved by the U.S. Food and Drug Administration to lower very high triglyceride levels. It is metabolized into Omega-3 fatty acids. It is a dietary supplement that has been purified, chemically altered, branded, and been put through the FDA's approval process; in these respects it is considered a pharmaceutical: unlike unregulated extracts, there is no risk of contamination by methyl mercury, arsenic [1], or other pollutants that are now omnipresent in the world's oceans. Each 1-gram capsule is 38% DHA, 47% EPA, and 17% other fish oils in the form of the ethyl ester.
Lovaza is named Omacor in Europe (and this name was once used in the US).[2]
Lovaza is approved in the U.S. for treatment of patients with very high triglycerides (hypertriglyceridemia).[3]
In the European markets and other major markets outside the US Lovaza is known as Omacor, and is indicated for:
Lovaza has been demonstrated to reduce triglycerides in patients with high or very high triglycerides. [3]
Lovaza has also been demonstrated to reduce VLDL-cholesterol and non-HDL-cholesterol, and increase HDL-cholesterol. In some patients LDL-cholesterol is moderately increased. The LDL raising activity correlates with a reduction in ApoB levels. Lovaza, through the stimulation of Lipoprotein Lipase, seems to stimulate the production of less atherogenic LDL species.
Effects on significant patient outcomes such as acute myocardial infarction, stroke, cardiovascular and all-cause mortality have been studied in patients who have suffered a myocardial infarction. Lovaza has not been shown to lower the rates of all cause mortality and cardiovascular mortality, and as well as the combination of mortality and non-fatal cardiovascular events.[3]
GlaxoSmithKline's patent expires in September 2012, when generic versions may be made available. Other DHA/EPA products containing similar amounts of Omega-3 fatty acids are currently sold over the counter in the United States as dietary supplements.