Clinical Review & Education

From The Medical Letter on Drugs and Therapeutics

Fish Oil Supplements Long-chain omega-3 polyunsaturated fatty acids (PUFAs), which are present in cold-water fish such as herring or salmon and are commercially available in capsules (over the counter and by prescription), can decrease fasting triglyceride concentrations 20-50% by reducing hepatic triglyceride production and increasing triglyceride clearance.1 With long-term intake, they may increase HDL-C.

Efficacy The results of recent studies do not offer any convincing evidence that fish oil supplements either prevent cardiovascular disease or improve outcomes in patients who already have it.2,3 Lovaza (formerly Omacor), a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), was the first omega-3 PUFA product to be approved by the FDA for treatment of severe hypertriglyceridemia (Table). Daily doses of 3-12 g can lower triglycerides by 20-50%, but have not been shown to prevent pancreatitis, which is a major concern in patients with very high triglycerides. Vascepa, the second FDA-approved omega-3 PUFA prod-

uct for treatment of severe hypertriglyceridemia, is the ethyl ester of EPA. In controlled trials, it has reduced triglyceride levels by 22-33% compared to placebo.4

Adverse Effects DHA can increase LDL-C levels, but EPA apparently does not. Fish oil supplements are generally well tolerated. Adverse effects have included eructation, dyspepsia, and an unpleasant aftertaste. Worsening glycemic control has been reported in diabetic patients taking large doses. Fish oil in large doses can also inhibit platelet aggregation and increase bleeding time; whether it could cause clinically significant bleeding has not been established.

Conclusion Omega-3 polyunsaturated fatty acids can lower high plasma triglycerides, but they have not been shown to decrease the risk of pancreatitis. The results of recent studies do not offer any convincing evidence that fish oil supplements prevent cardiovascular disease.

Table. Some Fish Oil Products Drug

Some Available Formulations

Usual Adult Daily Dosagea

Cost, $b

1000 mg capsc

2 caps bidd,e

184.00 210.80

Fish oil capsules Vascepa (Amarin)

f

Lovaza (GSK)

1000 mg caps

4 caps once or 2 caps bide

USP-verified fish oil capsulesg

1, 1.2 g capsh

4 caps tid

a

Dosage adjustment may be needed for renal or hepatic impairment.

b

Approximate wholesale acquisition cost (WAC) for 30 days’ treatment with the lowest usual adult dosage. Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) December 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may be higher.

c

Each 1-gram capsule contains 1000 mg EPA.

d

Should be taken with food.

e

FDA-approved dose for treating hypertriglyceridemia (ⱖ500 mg/dL).

f

Each 1-gram capsule contains about 465 mg EPA and 375 mg DHA

ARTICLE INFORMATION Once a month, JAMA selects for publication one article previously published in The Medical Letter.

(total 900 mg polyunsaturated fatty acids [PUFAs]). g

The US Pharmacopeia has verified that certain fish oil products contain their labeled content, are soluble in the body, and contain neither heavy metals nor contaminants. USP-verified fish oil products are manufactured by Berkley & Jensen, Kirkland, and Nature Made. Available without a prescription.

h

Most 1-gram capsules contain 300 mg PUFAs (180 mg EPA and 120 mg DHA); Nature Made Capsules are 1.2 g containing 360 mg PUFAs (216 mg EPA and 144 mg DHA). Three capsules are approximately equal to one Lovaza capsule.

i

Cost of 2 bottles containing 400 Nature Made capsules based on retail price at Costco.com. Accessed December 10, 2013.

subscriptions, books, software, continuing education materials, and licenses.

fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med. 2013;368(19):1800-1808.

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3. Kwak SM, Myung SK, Lee YJ, Seo HG; Korean Meta-analysis Study Group. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med. 2012;172(9):686-694.

Previous Publication: This article was previously published. Adapted from “Drugs for Lipids.” Treat Guidel Med Lett. 2014;12(137):1-6. ©The Medical Letter Inc.

Editors: Mark Abramowicz, MD, Editor in Chief; Gianna Zuccotti, MD, MPH, Executive Editor; JeanMarie Pflomm, PharmD, Editor

About The Medical Letter: The Medical Letter is a nonprofit organization that publishes biweekly new drug evaluations and treatment recommendations. The Medical Letter does not accept advertisements, gifts, grants, or donations. Financial support comes solely from sales of

REFERENCES

jama.com

18.00i

1. Fish oil supplements. Med Lett Drugs Ther. 2012; 54(1401):83-84. 2. Roncaglioni MC, Tombesi M, Avanzini F, et al; Risk and Prevention Study Collaborative Group. n-3

4. Isosapent ethyl (Vascepa) for severe hypertriglyceridemia. Med Lett Drugs Ther. 2013;55 (1415):33-34.

JAMA August 27, 2014 Volume 312, Number 8

Copyright 2014 American Medical Association. All rights reserved.

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