STEPS

New Drug Reviews

Icosapent Ethyl (Vascepa) for Hyperlipidemia/Hypercholesterolemia to Reduce Risk of Heart Attack and Stroke

 

Am Fam Physician. 2021 Jan 15;103(2):117-118.

Icosapent ethyl (Vascepa) is a purified ethyl ester of eicosapentaenoic acid (EPA).1 It can be used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels (150 mg per dL [1.69 mmol per L] or greater) and established cardiovascular disease (CVD) or diabetes mellitus and two or more additional risk factors for CVD.1,2 It can also be used as an adjunct to diet and lifestyle to treat patients with severe hypertriglyceridemia (i.e., triglyceride levels greater than 500 mg per dL [5.65 mmol per L]).1

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DrugDosageDose formCost*

Icosapent ethyl (Vascepa)

2 g taken twice daily with food

Capsules: 0.5 g, 1 g

$130


*—Estimated lowest GoodRx price for 30 days of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed December 7, 2020; zip code: 66211).

DrugDosageDose formCost*

Icosapent ethyl (Vascepa)

2 g taken twice daily with food

Capsules: 0.5 g, 1 g

$130


*—Estimated lowest GoodRx price for 30 days of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed December 7, 2020; zip code: 66211).

Safety

Atrial fibrillation occurs slightly more often in patients treated with icosapent ethyl (number needed to harm = 72) compared with placebo. Icosapent ethyl is also associated with an increased rate of hospitalization for atrial fibrillation or flutter (number needed to harm = 91).1,3 The likelihood of bleeding was slightly higher when patients taking an antithrombotic were given icosapent ethyl instead of placebo (12% vs. 10%).1,3 Because EPA is obtained from fish oil, there is a theoretical potential for allergic reaction in patients allergic to fish or shellfish.

Tolerability

Icosapent ethyl is generally well-tolerated. Adverse effects occur significantly more often with icosapent ethyl than with placebo and include musculoskeletal pain (35.9% vs. 34.4%), arthralgia (7.7% vs. 6.7%), edema (6.5% vs. 5.0%), constipation (5.4% vs. 3.6%), and gout (4.2% vs. 3.1%).1,3,4 Rates of indigestion and burping, which are common with fish oil, have not been reported.

Effectiveness

Icosapent ethyl reduces the risk of ischemic events in patients who have established CVD or

Address correspondence to Leena Myran, PharmD, BCPS, at lmyran@uwyo.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. Daily Med. Drug label information. Vascepa—icosapent ethyl capsule. Accessed July 30, 2020. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508...

2. Mach F, Baigent C, Catapano AL, et al.; ESC Scientific Document Group. 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41(1):111–188.

3. Bhatt DL, Steg PG, Miller M, et al.; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11–22.

4. U.S. Food and Drug Administration. FDA briefing document. Endocrinologic and Metabolic Drugs Advisory Committee meeting. November 14, 2019. Accessed July 30, 2020. https://www.fda.gov/media/132477/download

5. Bhatt DL, Steg PG, Brinton EA, et al.; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: reduction of cardiovascular events with icosapent ethyl–intervention trial. Clin Cardiol. 2017;40(3):138–148.

6. Maki KC, Guyton JR, Orringer CE, et al. Triglyceride-lowering therapies reduce cardiovascular disease event risk in subjects with hypertriglyceridemia. J Clin Lipidol. 2016;10(4):905–914.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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