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Lovaza (Omega-3-Acid Ethyl Esters) - Summary

 
 



LOVAZA SUMMARY

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 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.


See all Lovaza indications & dosage >>

NEWS HIGHLIGHTS

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.

more news >>

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. [2011]
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. [2011]
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.

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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 lipoprotein (HDL).

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.

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Reports of Suspected Lovaza (Omega-3-Acid Ethyl Esters) Side Effects

Product Quality Issue (50)Nausea (35)Dysgeusia (35)Diarrhoea (35)Eructation (30)Drug Ineffective (28)Blood Triglycerides Increased (27)Abdominal Pain Upper (23)Therapeutic Response Unexpected (22)Abdominal Discomfort (20)more >>


Page last updated: 2015-06-18

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