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Medications> Dyslipidemia>
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Omega-3 fatty acids (Fish Oils)

Simeon Margolis, M.D. and Paul A. Pham, Pharm.D.
04-14-2010

INDICATIONS

FDA

  • To reduce very high (> 500 mg/dL) triglyceride (TG) levels in adults (as an adjunct to diet).
NON-FDA APPROVED USES

  • Prevention of cardiovascular events and sudden death in patients with known cardiovascular disease (secondary prevention) (Lancet article; Rupp; Oikawa)
  • Prevention of arrhythmias (Rupp)

MECHANISM

Unknown mechanism, but omega-3 fatty acids appear to lower blood triglyceride levels by inhibiting triglyceride formation in the liver and reducing the release of very low density lipoproteins (VLDL) (Chan; Harris).

USUAL ADULT DOSING

  • Lovaza 4 gm (4 capsules) once-daily or 2 g (2 capsules) twice-daily.
  • Fish oil capsules 4 to 12 capsules per day.

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Lovaza omega-3-acid ethyl esters GlaxoSmithKline oral
soft gel capsule
1 gm
$1.52 per capsule
Fish oilomega-3 fatty acids Several major pharmaceutical and other supplement manufacturersoral
capsules
1 gm
$0.10 per capsule

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

DOSING IN SPECIAL POPULATIONS

RENAL

  • No special dosing needed
HEPATIC

  • No data
PREGNANCY

  • Category C: not teratogenic in animal studies
BREASTFEEDING

  • No data.

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated
  • Weight gain
COMMON

  • Increase LDL cholesterol (Balk)
OCCASIONAL

  • GI: nausea, abdominal pain, and eructation (belching)
  • Taste perversion
  • Rash
  • Increased ALT levels were observed without increase in AST

DRUG INTERACTIONS

Limited data and no human studies

  • Aspirin: may increase bleeding time.
  • Warfarin: may increase bleeding time. Although in clinical studies omega-3-fatty acid did not produce clinically significant bleeding episodes, patients should be closely monitored.
  • Clopidogrel: may increase bleeding time.
  • Propranolol: may enhance anti-hypertensive effect.
  • Lopinavir: did not affect lopinavir plasma concentrations.

PHARMACOKINETIC

COMMENTS

  • Fish oils are safe and effective way to lower triglyceride levels in patients with diabetes, although no Phase I studies have been performed using fish oils.
  • They can lower triglycerides by about 30-50% in patients with severe hypertriglyceridemia (> 500 mg/dL) compared to placebo (Balk; Harris).
  • Lovaza:nearly 90% long-chain omega-3 fatty acids. More expensive, but taking smaller amounts of fatty acids in Lovaza than in standard fish oil capsules reduces potential weight gain and the likelihood of unpleasant upper GI symptoms.
  • Convincing evidence that fish oil is effective in preventing cardiovascular events in secondary prevention (Lancet article; Oikawa).
  • In combination with fibrate and/or statins, Lovaza can further decrease serum TG levels, but may increase LDL by 6 mg/dl (Balk, Davidson).
  • The major coronary heart disease benefit: prevention of sudden death, probably by stabilizing or preventing dangerous arrhythmias (Lancet article; Rupp; Oikawa).

REFERENCES


 
 
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