LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
LOVAZA« (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting LOVAZA therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as betaáblockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined.
Published Studies Related to Lovaza (Omega-3-Acid Ethyl Esters)
Prescription omega-3-acid ethyl esters reduce fasting and postprandial triglycerides and modestly reduce pancreatic beta-cell response in subjects with primary hypertriglyceridemia. [2011.09]
Treatment with prescription omega-3-acid ethyl esters (POM3) reduces triglycerides (TG) and TG-rich lipoprotein particles, but has been associated with increased fasting glucose (2-6mg/dL). This double-blind, randomized, controlled crossover trial in 19 men and women with hypertriglyceridemia (fasting TG >/=150 and </=499mg/dL) examined lipid responses and indices of insulin sensitivity and secretion following a liquid meal tolerance test...
Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. [2011.04]
This double-blind, randomized crossover study investigated the effects of 6 weeks of treatment with prescription omega-3-acid ethyl esters (POM3, 4 g/day) versus placebo (soy oil) on low-density lipoprotein cholesterol (LDL-C) and other aspects of the fasting lipid profile in 31 men and women with primary, isolated hypercholesterolemia (LDL-C 130-220 mg/dL and triglycerides less than 150 mg/dL while free of lipid-altering therapies)...
Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in
subjects with primary hypercholesterolemia. 
This double-blind, randomized crossover study investigated the effects of 6 weeks
of treatment with prescription omega-3-acid ethyl esters (POM3, 4 g/day) versus
placebo (soy oil) on low-density lipoprotein cholesterol (LDL-C) and other
aspects of the fasting lipid profile in 31 men and women with primary, isolated
hypercholesterolemia (LDL-C 130-220 mg/dL and triglycerides less than 150 mg/dL
while free of lipid-altering therapies)...
Effects of prescription omega-3-acid ethyl esters, coadministered with
atorvastatin, on circulating levels of lipoprotein particles, apolipoprotein
CIII, and lipoprotein-associated phospholipase A2 mass in men and women with
mixed dyslipidemia. 
mixed dyslipidemia... CONCLUSION: This analysis supports the view that LDL-P concentration is not
Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients. [2010.04]
OBJECTIVE: Assess the long-term efficacy and safety of prescription omega-3-acid ethyl esters (P-OM3) coadministered with simvastatin in an extension of the Combination of Prescription Omega-3 Plus Simvastatin (COMBOS) trial... CONCLUSIONS: In this 24-month extension study, P-OM3 was generally well tolerated, and produced sustained reductions in non-HDL-C levels in simvastatin-treated patients with TG levels between 200 and 500 mg/dL (2.26 mmol/L and 5.64 mmol/L). CLINICAL TRIAL REGISTRY NUMBER: NCT00903409.
Clinical Trials Related to Lovaza (Omega-3-Acid Ethyl Esters)
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia [Recruiting]
Study hypothesis: Lovaza (purified prescription fish oil) is likely to help HDL (the "good
cholesterol") work better.
Study summary: We are testing effects of Lovaza versus placebo, on various aspects of HDL
and other lipoproteins, in patients with high triglyceride levels.
Study funding: This study is being funded by an investigator-initiated research grant from
Glaxo Smith Kline.
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease [Recruiting]
Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription
for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be
a reduction in hepatic production of triglycerides. Also decreases the hepatic production of
very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The
thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is
two fold. It would help in the decrease production of triglycerides by the liver and have
antioxidant properties decreasing the production of free radicals in the liver. In doing so,
steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.
Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals [Recruiting]
The primary objective of this study is to determine the effect of Epanova« on the
pharmacokinetic and anticoagulant activity of warfarin.
The secondary objective of this study is to compare the systemic exposure of EPA and DHA
following multiple-dose administration of Epanova«, a free fatty acid mixture, to Lovaza«, a
mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are
likely to be administered to patients with cardiovascular disease who are recommended to
consume low-fat meals.
Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Heart Function in Patients With Mitral Valve Disease [Recruiting]
In the absence of treatment, severe mitral valve regurgitation (MR) results in left atrium
(LA) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and
heart failure. One promising intervention for the prevention of the deleterious effects of
pressure overload-induced cardiac hypertrophy and heart failure is dietary supplementation
with n-3 polyunsaturated fatty acids (PUFAs). However, the molecular targets and mechanisms
by which n-3 PUFAs exert their effects are not completely defined. A possible target of n-3
PUFAs is the mitochondrial membrane which has broad implications given that mitochondrial
dysfunction and altered metabolism have been associated with cardiac hypertrophy and heart
failure. The investigators have recently identified significant mitochondrial dysfunction
in the LA of patients with severe MR, as compared to their non-hypertrophied right atrium
(RA). However, the investigators have not addressed the possibility that intervention with
purified n-3 PUFAs (Lovaza) could improve mitochondrial function. From a mechanistic
perspective, the investigators have observed in vitro that n-3 PUFAs accumulate
predominately into the mitochondrial membrane of cardiomyocytes where the investigators
believe they exert their effects on the biophysical organization of the membrane.
Therefore, the CENTRAL HYPOTHESIS is that administering Lovaza to patients with severe MR
will reduce apoptosis and improve mitochondrial function in LA (Aim 1). This change in
mitochondrial function will be driven by significant biochemical and biophysical remodeling
of the mitochondrial membrane (Aim 2).
Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia [Not yet recruiting]
Omacor«/Lovaza« is an effective, and very safe mix of PO-3A, and the drug is currently
approved by the Federal authorities for the drug management of post-infarction patients with
high blood triglycerides. Given the growing length of CAD progression, it is pertinent that
many more patients will yield extra benefit from Lovaza« on top of aggressive antiplatelet
regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet
properties of PO-3A will be a highly desirable and attractive commodity of this medication.
The investigators believe that Omacor┬«/Lovaza┬« is ideally positioned for the chronic
management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with
statins or aspirin.
The investigators hypothesize that addition of Omacor may add mild antiplatelet protection
for CAD patients.
The study objectives are:
- To assess the ex vivo effects of Omacor┬« on platelet function in patients with coronary
artery disease (CAD).
- To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor
and statin combination versus statin alone in patients with chronic stable coronary
- To establish the relation of changes in platelet activity (if any) with the lipid
profile to prove an additional benefit of Omacor┬« on top of statin and aspirin.
Reports of Suspected Lovaza (Omega-3-Acid Ethyl Esters) Side Effects
Product Quality Issue (50),
Drug Ineffective (28),
Blood Triglycerides Increased (27),
Abdominal Pain Upper (23),
Therapeutic Response Unexpected (22),
Abdominal Discomfort (20), more >>