Lovaza

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Lovaza is a brand name prescription drug. The capsule sold by GlaxoSmithKline but developed by Reliant Pharmaceuticals, 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 approval process of the U.S. Food and Drug Administration (FDA); in these respects it is considered a pharmaceutical. Due to the esterification process during manufacturing there is no risk of contamination[citation needed] by methylmercury, arsenic,[1] or other pollutants that are often seen 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]

Effectiveness[edit]

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:

  1. Hypertriglyceridemia. Used as monotherapy, or in combination with a statin for patients with mixed dyslipidemia.[citation needed]
  2. Secondary prevention after myocardial infarction (heart attack)[citation needed]

in addition to other standard therapy (e.g. statins, antiplatelets medicinal products, beta-blockers, and ACE-I).

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. But, it can raise LDL-cholesterol up to 45%.[4] The LDL raising activity correlates with a reduction in ApoB levels, though. Lovaza, through the stimulation of Lipoprotein Lipase, seems to stimulate the production of less atherogenic LDL species. In some patients, it can elevate alanine transaminase levels, so liver enzymes should be checked, periodically.[4]

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, or the combination of mortality and non-fatal cardiovascular events.[3]

GlaxoSmithKline's patent expired in September 2012. Generic versions may be made available at that time. 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.

Competitors[edit]

In July 2012, Amarin Corporation received U.S. FDA marketing approval for Vascepa, also referred to as AMR-101.[5] Vascepa will undoubtedly become a major competitor for Lovaza.[6] In clinical trials, Vascepa was shown to lower triglycerides; while Lovaza also lowers the triglyceride concentration, Vascepa also lowers LDL-C; Lovaza does not. Lovaza was approved to treat people with very high triglyceride levels (>500 mg/dl), Vascepa is also approved for this market; however the company has also demonstrated that the drug can impact levels in people with high triglyceride (> 200 mg/dl and < 500 mg/dl) levels and will file an sNDA for this indication late in 2012.[7]

Forms of Lovaza[edit]

Lovaza is available as 1-gram soft-gelatin capsules.[8]

Active Ingredient: Omega-3-acid ethyl esters

Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)

References[edit]

External links[edit]