Lovaza - Effectiveness

Effectiveness

Lovaza is approved in the U.S. for treatment of patients with very high triglycerides (hypertriglyceridemia).

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.
2. 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%. 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 (this is in the US; however, data from GISSI-P showed a combined end-point of all-cause death, non-fatal MI, and non-fatal stroke was significantly reduced by 15%). 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 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.