Clinical benefit is strongest for lowering the risk of coronary artery disease and decreasing serum triglycerides. Reductions in the risk for all-cause mortality, cardiac death, and sudden death have been established for omega-3 fatty acid supplementation for at least 1 year's duration. The United States Food and Drug Administration (FDA) has approved the use of fish oil for reducing very high triglyceridemia (at least 500 mg/dL [5.65 mmol/L]) in adults as an adjunct to diet. Evidence for use of parenteral fish oil lipid emulsion is mounting in severely ill and surgical patients. Evidence for a role in rheumatoid arthritis remains equivocal but promising. No consistent relationship between fish oil consumption and reduction in the risk of stroke or maintenance in inflammatory bowel disease has been established. Other areas of interest in the therapeutic use of fish oils requiring further study include asthma and allergy, dysmenorrhea, mental health, and the promotion of postnatal growth and development.
Vascepa/ Lovaza fish oil contains Omega 3 acid ethyl esters has been approved by the FDA in reducing the risk of cardiovascular diseases.
It reduces plaque formation and cardiovascular mortality.
Vascepa/ Lovaza (Omega-3-acid ethyl esters) Uses:
Dietary supplement:
Used as dietary supplements for patients at early risk of coronary artery disease
Note:
Recommendations from the American Heart Association (AHA) state that patients without documented coronary heart disease (CHD) should eat a variety of fish, preferably oily fish (eg, salmon), at least twice weekly, or daily in patients with documented CHD.
Hypertriglyceridemia (Lovaza and Vascepa):
As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.
Note:
The Endocrine Society recommends that omega-3 fatty acids may be considered for triglyceride levels >1,000 mg/dL and may be used alone or in combination with HMG-CoA reductase inhibitors.
A number of OTC formulations containing omega-3 fatty acids are marketed as nutritional supplements; these do not have FDA-approved indications and may not contain the same amounts of the active ingredient.
Off Label Use of Omega-3-acid ethyl esters Adults:
Cardiovascular risk reduction with mild hypertriglyceridemia
IgA nephropathy
Omega-3-acid ethyl esters dose in the treatment of Cardiovascular risk reduction with mild hypertriglyceridemia (off-label):
Note:
Consider for use in patients with a history of cardiovascular disease (CVD) or diabetes plus additional CVD risk factors who are already receiving a stable statin dose and have an LDLcholesterol <100 mg/dL, but continue to have fasting triglycerides of 150 to 499 mg/dL.
Oral:
Vascepa: 2 g twice daily with meals.
Vascepa/ Lovaza Dose in the treatment of Hypertriglyceridemia:
Lovaza:
4 g (4 capsules) orally once daily or 2 g (2 capsules) twice a day.
Vascepa:
2 g (2 [1 gram] capsules or 4 [0.5 g] capsules) orally twice a day with meals.
Lovaza Dose in the treatment of IgA nephropathy (off-label):
Oral:
Lovaza: 4 g (4 capsules) once daily.
Omega-3-acid ethyl esters Use in children:
The safety and efficacy of Omega-3-acid ethyl esters in children are not established.
Pregnancy Risk Factor C
Animal reproduction studies have shown that adverse events can be observed.
It is important to get enough omega-3 fatty acid during pregnancy.
Supplementation by mothers or dietary intake of omega-3 fatty acid (containing eicosapentaenoic and docosahexaenoic acids [DHA]), can have an impact on fetal concentrations.
As normal fetal development requires, glyceride levels increase in pregnancy.
If increases are more than expected, supervised dietary interventions may include omega-3 fatty acid supplements.
Prescription omega-3 fatty acids products may be an option for women with very severe hypertriglyceridemia or at high risk of developing pancreatitis.
Omega-3-acid ethyl esters use during breastfeeding:
Breast milk contains Omega-3 fatty acid and dietary supplements can affect milk concentrations.
According to the manufacturer of the product, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks to infant exposure, the benefits to the infant and the benefits to the mother.
Omega-3-acid ethyl esters Dose in Kidney Disease:
No dosage adjustments provided in the manufacturer’s labeling (has not been studied). EPA and DHA are not renally excreted.
Vascepa Dose in Liver Disease:
No dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Common Side Effects of Vascepa (Omega-3-acid ethyl esters):
Gastrointestinal:
Diarrhea
Less Common Side Effects of Vascepa (Omega-3-acid ethyl esters):
Gastrointestinal:
Nausea
Abdominal Pain
Dysgeusia
Eructation
Dyspepsia
Neuromuscular & Skeletal:
Arthralgia
Side effects of Omega-3-acid ethyl esters (Frequency not known):
Central Nervous System:
Fatigue
Dermatologic:
Pruritus
Skin Rash
Endocrine & Metabolic:
Increased LDL Cholesterol
Gastrointestinal:
Abdominal Distension
Constipation
Flatulence
Gastrointestinal Disease
Vomiting
Hematologic & Oncologic:
Prolonged Bleeding Time
Hepatic:
Increased Serum Alanine Aminotransferase
Increased Serum Aspartate Aminotransferase
Respiratory:
Nasopharyngitis
Oropharyngeal Pain
Contraindications to Vascepa (Omega-3-acid ethyl esters):
Hypersensitivity to omega-3 fatty acid or any component of the formulation (eg, anaphylactic response)
Warnings and precautions
Fish allergy
Patients with an allergy to shellfish or fish should be cautious.
Hepatic effects
The ALT could increase without AST concurrently
Monitor the hepatic transaminases of patients with hepatic impairment periodically.
The Lipid Effects
May raise LDL levels
Monitor LDL levels periodically.
Longer bleeding time
Some clinical studies using omega-3 fatty oils have shown that bleeding times do not increase beyond normal limits.
Patients with coagulopathy and those on anticoagulation therapy or therapeutic anticoagulation should be cautious.
Monitor for changes in INR following initiation and dosage changes of omega-3 fatty acids in patients receiving warfarin.
Atrial fibrillation (AF):
Flutter or AF is not a condition that Omega-3 fatty acids can be used to treat.
Patients with persistent or symptomatic AF may experience recurrent AF.
In clinical trials, omega-3 fatty acid therapy was more frequent than placebo.
These results are not clinically significant.
Conditions that are associated with abnormal lipids
Concurrent conditions such as diabetes, hypothyroidism or excessive alcohol intake can be managed to prevent lipid abnormalities.
Monitoring Parameters:
Triglycerides and other lipids (LDL-C) should be monitored at baseline and periodically.
In patients with hepatic impairment, monitor hepatic transaminase levels, particularly ALT, periodically.
Consider evaluation for GI disturbances, skin changes, and bleeding during therapy.
How to administer Vascepa (Omega-3-acid ethyl esters)?
Lovaza:
Administer with or without food.
Administer whole; do not break, crush, dissolve, or chew.
Vascepa:
Administer with meals.
Administer whole; do not break, crush, dissolve, or chew.
Mechanism of action of Vascepa (Omega-3-acid ethyl esters):
Reduced production by the liver of triglyceride rich very-low density lipoproteins.
One possible mechanism is inhibition of acyl CoA1:2, diacylglycerol-acyltransferase, increased liver mitochondrial and peroxisomal benzo-oxidation, as well as a decrease in hepatic synthesis for triglycerides.
Absorption:
The small intestine absorbs Omega-3-carboxylic acid directly.
Administration of high-fat meals results in an increase in overall exposure to total and free baseline-adjusted EPA, respectively, compared with fasting conditions.
A 40% increase in AUC was observed for baseline-adjusted DHA.
Icosapent ethyl:
De-esterified to an active metabolite (EPA) which is absorbed in the small intestine
Protein binding:
EPA: >99%
Metabolism:
EPA and DHA are mainly oxidized in the liver similar to fatty acids derived from dietary sources.
EPA: minor via CYP-450
Half-life elimination:
EPA: ~37 to 89 hours;
DHA: ~46 hours
Time to peak plasma concentrations:
Omega-3-carboxylic acids:
Following repeat dosing with low-fat meals for ~2 weeks (steady-state)
EPA: 5 to 8 hours
DHA: 5 to 9 hours
Icosapent ethyl:
EPA: ~5 hours
Toxicology
Research reveals limited information regarding toxicology with the use of fish oil supplementation. Omega-3 acid ethyl esters have shown an embryocidal effect in pregnant rats when given in doses 7 times the recommended human dose of 4 g/day based on a body surface area comparison
International Brands of Omega-3-acid ethyl esters:
Dialyvite Omega-3 Concentrate
Expecta LIPIL
Fish Oil Concentrate
Lovaza
Maximum Red Krill
Ocean Blue MiniCaps Omega-3
Odorless Coated Fish Oil
Omega Power
Omega-3 2100
Omega-3 Fish Oil Ex St
Omega-3 IQ
Pro Nutrients Omega 3
Salmon Oil-1000
Sam-E.P.A.
Sea-Omega
Triklo
Vascepa
Agemo
Dualtis
Epax
Equiplen
Nebbaro
Omacor
Omaron
Ysomega
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