OMACOR SUMMARY
OMACOR®
(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.
Usage Considerations
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).
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NEWS HIGHLIGHTSMedia Articles Related to Omacor (Omega-3-Acid Ethyl Esters)
omega-3-acid ethyl esters (Lovaza)
Source: MedicineNet Angina Specialty [2009.11.10]
Title: omega-3-acid ethyl esters (Lovaza)
Category: Medications
Created: 11/10/2009 2:53:00 PM
Last Editorial Review: 11/10/2009 2:53:29 PM
Published Studies Related to Omacor (Omega-3-Acid Ethyl Esters)
Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation: a prospective study. [2009.08]
BACKGROUND: Atrial fibrillation (AF) continues to be one of the most common cardiac problems, placing an expanding burden on the public health system. In several circumstances, AF can increase the risk of stroke and heart failure. Current pharmacologic treatment options are associated with the potential for significant adverse events, which often outweigh the benefits of achieving sinus rhythm. There is evidence to suggest antiarrhythmic benefits of omega-3 polyunsaturated fatty acids; however, the data are not conclusive. This study is designed to further assess the effect of prescription omega-3 ethyl esters (P-OM3) in the prevention of recurrent AF in patients with AF without (significant) structural heart disease... CONCLUSION: This is the first randomized blinded trial to assess the antiarrhythmic effects of 4 g/d P-OM3 in paroxysmal AF.
Effect of omega-3-acid ethyl esters on the steady-state plasma pharmacokinetics of rosuvastatin in healthy adults. [2008.12]
BACKGROUND: Patients with persistent hypertriglyceridemia while on statin therapy may require adjunctive lipid-lowering therapy to meet treatment goals. OBJECTIVE: To assess the effect of concomitant administration of prescription omega-3-acid ethyl esters (P-OM3), triglyceride-lowering agents, on the steady-state pharmacokinetics of rosuvastatin... CONCLUSIONS: Administration of P-OM3 with rosuvastatin did not affect the pharmacokinetics of rosuvastatin under steady-state conditions in healthy individuals.
Effect of omega-3-acid ethyl esters on steady-state plasma pharmacokinetics of atorvastatin in healthy adults. [2008.12]
BACKGROUND: Prescription omega-3-acid ethyl esters (P-OM3) have been used as adjunctive therapy to statin drugs in patients with mixed hyperlipidemia. OBJECTIVE: To assess the effect of concomitant administration of 4 g P-OM3 on the steady-state pharmacokinetics of the maximum recommended daily dose of atorvastatin (80 mg) in healthy volunteers... CONCLUSIONS: After 14 days of dosing, the rate and extent of exposure (AUCtau, C(max,ss)) to atorvastatin and its active metabolites were similar with both treatments, indicating that administration of P-OM3 did not affect the steady-state bioavailability of orally administered atorvastatin.
Study of the pharmacokinetic interaction between simvastatin and prescription omega-3-acid ethyl esters. [2006.07]
The coadministration of prescription omega-3-acid ethyl esters (P-OM3) with a statin may present a treatment option for patients with mixed hyperlipidemia. This open-label, randomized, 2-way crossover, drug-drug interaction study evaluated the impact of P-OM3 capsules on plasma simvastatin pharmacokinetics in 24 healthy volunteers...
Effect of Omacor on HRV parameters in patients with recent uncomplicated myocardial infarction - A randomized, parallel group, double-blind, placebo-controlled trial: study design [ISRCTN75358739]. [2003.10.15]
BACKGROUND: A large body of data derived from animal, epidemiological and clinical studies indicate that n-3 polyunsaturated fatty acids have a favourable effect on the prognosis of patients with cardiovascular disease in general, and on reducing sudden death in particular.Depressed heart rate variability (HRV), an indicator of impairment of the autonomic nervous system, has been shown to be a powerful predictor of subsequent mortality in patients surviving an acute myocardial infarction...
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| 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 | | |
Reported Results |
| 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. |
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Page last updated: 2009-11-10
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