(omega-3-acid ethyl esters) Capsules
Omacor, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each one gram capsule of Omacor (omega-3 acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).
Omacor is indicated as an adjunct to diet to reduce very high (≥ 500 mg/dL) triglyceride (TG) levels in adult patients.
According to accepted clinical guidelines, excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia (HTG) and should be addressed before initiating any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, (such as hypothyroidism or diabetes mellitus) should be looked for and adequately treated. Estrogen therapy, thiazide diuretics, and beta blockers are sometimes associated with massive rises in plasma TG levels. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy for HTG.
The use of lipid-regulating agents should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use lipid-regulating agents, the patient should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet. (See PRECAUTIONS).
Published Studies Related to Omacor (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, 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
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)...
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 Omacor (Omega-3-Acid Ethyl Esters)
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment [Completed]
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-Acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects Followed by a 2 Year Extension. [Completed]
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl
esters) combined with simvastatin for lowering non-high-density lipoprotein cholesterol in
subjects with persistent high triglycerides despite statin therapy.
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 2 Extensions [Completed]
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.
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia [Completed]
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid
ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein
cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia [Completed]
The primary objective of this study is to compare the effect of simvastatin plus Omacor to
simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects
with mixed dyslipidemia.
Reports of Suspected Omacor (Omega-3-Acid Ethyl Esters) Side Effects
OFF Label USE (7),
Premature Labour (6),
Liver Function Test Abnormal (5),
Blood Cholesterol Increased (5),
Blood Bilirubin Increased (4),
Blood Alkaline Phosphatase Increased (4), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Omacor has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Omacor review by 40 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || high cholesterol|
|Dosage & duration:|| || 2 capsules taken 2 times daily for the period of 4 months|
|Other conditions:|| || gastroparesis; tachycardia; migraines; asthma|
|Other drugs taken:|| || topamax; nexium; potassium; advair; rhinocort; singulair; xoepenix|
|Benefits:|| || lowered total cholesterol by 40 points |
|Side effects:|| || continual belching of "fishy" taste|
|Comments:|| || Both my husband & I have taken this medication. His results have been more dramatic than mine. He has seen a total cholesterol level lowering of 60 points to less than 200. Mine has lowered to just above 200 at 215, which is the lowest I've seen. There are minimal side effects. Mostly a "fishy" taste for 2-4 hours after taking the medication. Since I have difficulty digesting most vitamins, this is to be expected. My husband has had no side effects with this medication what so ever. It has the additional effect of lowering triglycerides. While it is a prescription medication, it is concentrated Omega 3's & has proven the safest way for us to bring our high cholesterol to a manageable level after failing with diet & exercise.|
Page last updated: 2013-02-10