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
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 beta blockers, 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.
Media Articles Related to Lovaza (Omega-3-Acid Ethyl Esters)
Hyperlipidemia: Causes, Diagnosis and Treatments
Source: Statins News From Medical News Today [2015.06.18]
Hyperlipidemia refers to increased levels of lipids in the blood, including cholesterol and triglycerides. Managing hyperlipidemia means controlling cholesterol and triglycerides.
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)
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.
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension [Completed]
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid
ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of
patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of
adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects
treated with fenofibrate in lowering serum triglyceride (TG) levels.
Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia [Withdrawn]
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.
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia [Completed]
This study will build upon a previous finding that showed a triglyceride lowering effect of
prescription omega-3 in combined therapy with statins. The proposed study will use a simple
change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin
therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 -
screening (blood draw for qualification and safety); day 7 - before taking prescription
omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 - after taking
prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study
will include up to 15 subjects and will utilize several different measures of lipoprotein
structure and function. The investigators will measure functional parameters such as the
binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The
investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma,
very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density
Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides [Terminated]
The investigators will conduct a randomized clinical trial to evaluate the efficacy of
Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years
old whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will
be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6
months or the control condition, a corn oil placebo, 4 tablets a day for 6 months.
Participants in both the treatment and control groups will receive the standard of care,
which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet
that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of
fishes rich in omega-3 fatty acids, consistent with the American Heart Association
recommendations. The primary outcome will be change in fasting triglycerides from baseline
to 3 months. The investigators hypothesize that patients who receive LOVAZA will have
significantly greater reductions in plasma triglyceride levels when compared to patients on
placebo at 3 months.
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 >>