|
Lovaza is a brand name prescription drug. The capsule sold by GlaxoSmithKline but developed by Reliant Pharmaceuticals, contains esterified fatty acid ethyl esters and is described in detail in . Pronova BioPharma is the innovator company for the APIs in Lovaza/Omacor. It is synthesized from fish body oils, typically from oily fish such as mackerel and anchovy. It is approved by the FDA (Food and Drug Administration) to lower very high triglyceride levels. It is a pro-drug that is metabolized into Omega-3 fatty acids and ethanol. It is not a dietary supplement. It is a pharmaceutical drug with the two main active pharmaceutical ingredients (API) being EPA-ethyl ester and DHA-ethyl ester. After the esterification process, molecular distillation is used to decrease organic pollutants, methylmercury, arsenic,〔(NIFES (Nasjonalt institutt for ernærings- og sjømatforskning – Norwegian National Institute for Nutrition and Seafood Research) )〕 or other pollutants that are often seen in the world's oceans. Each capsule weighs (drug product) 1.43089 g and contains 0.99461 grams of liquid. This is composed of 465 mg EPA ethyl ester and 375 mg DHA ethyl ester. There is an additional approximately 130 mg of other omega-3 fatty acid ethyl esters. Lovaza is named ''Omacor'' in Europe (and this name was once used in the US).〔(University of Utah Pharmacy Services (August 15, 2007) "Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza" )〕 ==Effectiveness== Lovaza is approved in the U.S. for treatment of patients with very high triglycerides (hypertriglyceridemia).〔(GSK Information for Medical Professionals )〕 In the European markets and other major markets outside the US Lovaza is known as Omacor, and is indicated for: # Hypertriglyceridemia. Used as monotherapy, or in combination with a statin for patients with mixed dyslipidemia. # Secondary prevention after myocardial infarction (heart attack) 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. 〔 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%.〔(Pharmacy & Therapeutics (May, 2008) "Omega-3-acid Ethyl Esters (Lovaza) For Severe Hypertriglyceridemia" )〕 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.〔 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.〔 GlaxoSmithKline's patent expired in September 2012. Generic versions of Lovaza were introduced in America in April 2014.〔http://www.empr.com/teva-launches-generic-lovaza/article/342205/ Teva Launches Generic Lovaza〕 Other DHA/EPA products containing similar amounts of omega-3 acid ethyl esters that are currently sold over the counter in the United States as dietary supplements. These products also produce ethanol as a metabolite. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Lovaza」の詳細全文を読む スポンサード リンク
|