Omega-3-Acid Ethyl Esters

Hypertriglyceridemia

Treatment

2 FDA approvals

6 Active Studies for Omega-3-Acid Ethyl Esters

What is Omega-3-Acid Ethyl Esters

Omega-3-acid ethyl esters

The Generic name of this drug

Treatment Summary

Omega-3-acid ethyl esters are a type of prescription medication used to lower triglyceride levels in adults with very high triglyceride levels (above 500 mg/dL). The drug is found under the brand name Lovaza in the US, EU, and other regions. It is taken in combination with dietary changes to reduce triglyceride levels.

Tandem DHA

is the brand name

image of different drug pills on a surface

Omega-3-Acid Ethyl Esters Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tandem DHA

Omega-3-acid ethyl esters

2007

57

Approved as Treatment by the FDA

Omega-3-acid ethyl esters, also called Tandem DHA, is approved by the FDA for 2 uses which include Severe Hypertriglyceridemia (sHTG) and Hypertriglyceridemia .

Severe Hypertriglyceridemia (sHTG)

Helps manage Severe Hypertriglyceridemia (sHTG)

Hypertriglyceridemia

Helps manage Severe Hypertriglyceridemia (sHTG)

Effectiveness

How Omega-3-Acid Ethyl Esters Affects Patients

Omega-3-acid ethyl esters help to lower triglyceride levels, speed up how your body breaks down fatty acids, prevent fatty acids from being released, increase the rate at which triglycerides are cleared from the body, and reduce very low density lipoprotein cholesterol (VLDL-C).

How Omega-3-Acid Ethyl Esters works in the body

Omega-3-acid ethyl esters lower triglyceride levels in the body by reducing the amount of triglycerides produced in the liver. They also block the release of fatty acids, which helps the body break down triglycerides faster. Finally, they increase the activity of an enzyme called lipoprotein lipase, which helps clear away triglycerides from the body.

When to interrupt dosage

The prescribed dosage of Omega-3-Acid Ethyl Esters is contingent upon the determined condition. The amount of dosage may be found in the table beneath, contingent upon the technique of administration.

Condition

Dosage

Administration

Hypertriglyceridemia

, 1000.0 mg, 300.0 mg, 900.0 mg, 1.0 mg/mg, 500.0 mg, 250.0 mg, 667.0 mg, 1050.0 mg, 430.0 mg, 400.0 mg, 200.0 mg, 310.1 mg, 1220.0 mg

Capsule, liquid filled, , Oral, Capsule, liquid filled - Oral, Capsule - Oral, Capsule, Capsule, Delayed Release, Capsule, Delayed Release - Oral, Kit, Kit - Oral, Tablet - Oral, Tablet

Warnings

Omega-3-Acid Ethyl Esters has one contraindication and should never be taken in the presence of any of the conditions described in the following table.

Omega-3-Acid Ethyl Esters Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Omega-3-acid Ethyl Esters may interact with Pulse Frequency

There are 20 known major drug interactions with Omega-3-Acid Ethyl Esters.

Common Omega-3-Acid Ethyl Esters Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Minor

The risk or severity of bleeding can be increased when Omega-3-acid ethyl esters is combined with (R)-warfarin.

(S)-Warfarin

Minor

The risk or severity of bleeding can be increased when Omega-3-acid ethyl esters is combined with (S)-Warfarin.

4-hydroxycoumarin

Minor

The risk or severity of bleeding can be increased when Omega-3-acid ethyl esters is combined with 4-hydroxycoumarin.

Abciximab

Minor

The risk or severity of bleeding can be increased when Omega-3-acid ethyl esters is combined with Abciximab.

Acenocoumarol

Minor

The risk or severity of bleeding can be increased when Omega-3-acid ethyl esters is combined with Acenocoumarol.

Omega-3-Acid Ethyl Esters Toxicity & Overdose Risk

Studies in rats have found that omega-3-acid ethyl esters are not dangerous and do not affect fertility. It is unclear if it is safe to use during pregnancy, but it has been linked to an embryocidal effect in rats when taken in high doses. It is also unknown if it is safe for nursing mothers or children, and it has not been tested on those under the age of 60.

image of a doctor in a lab doing drug, clinical research

Omega-3-Acid Ethyl Esters Novel Uses: Which Conditions Have a Clinical Trial Featuring Omega-3-Acid Ethyl Esters?

Currently, there are 4 active trials assessing the potential of Omega-3-Acid Ethyl Esters to treat Hypertriglyceridemia.

Condition

Clinical Trials

Trial Phases

Hypertriglyceridemia

5 Actively Recruiting

Phase 3

Omega-3-Acid Ethyl Esters Reviews: What are patients saying about Omega-3-Acid Ethyl Esters?

5

Patient Review

2/28/2021

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

I had extremely high triglyceride levels when I started taking this medication, but they normalized within five weeks.

5

Patient Review

2/16/2016

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

No noticeable side effects when taking 4 grams per day.

4.7

Patient Review

8/6/2015

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

Lovaza has been hugely effective in managing my cholesterol and osteoarthritis. I don't have any swelling or pain in my joints anymore.

4.7

Patient Review

8/30/2011

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

4

Patient Review

2/23/2008

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

2.3

Patient Review

3/20/2022

Omega-3-Acid Ethyl Esters for High Amount of Triglyceride in the Blood

I took this medication for two months and saw no results. In fact, my Thyroid Stimulating Ultrasens, Alanine Aminotraseferase, and Aspartate Aminotraneferase have all increased. Now I'm worried about my health condition.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about omega-3-acid ethyl esters

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is omega-3-acid ethyl esters used for?

"Omega-3-acid ethyl esters are used to lower triglyceride levels when following a proper diet. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes. This medicine is available with a doctor's prescription."

Answered by AI

Is omega-3-acid ethyl esters safe?

"Omega-3-Acid Ethyl Esters capsules may cause serious side effects, including changes in certain blood tests. Omega-3-Acid Ethyl Esters capsules may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels."

Answered by AI

What is the difference between omega-3 and omega-3 ethyl esters?

"The two different forms of omega-3 fatty acids, EPA and DHA, occur naturally in fish in the triglyceride form. The ethyl ester form is synthesized from the triglyceride form."

Answered by AI

Clinical Trials for Omega-3-Acid Ethyl Esters

Image of Clinical Research Site 4 in Santa Clarita, United States.

Plozasiran for Hypertriglyceridemia

18+
All Sexes
Santa Clarita, CA

This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Phase 3
Recruiting

Clinical Research Site 4 (+9 Sites)

Arrowhead Pharmaceuticals

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