Vascepa Approved for Prevention of Cardiovascular Events

By Jessica Pyhtila, PharmD, BCGP, BCPS

On December 13, 2019, the FDA approved icosopent ethyl, sold under the brand name Vascepa, for the prevention of cardiovascular events as an add-on to maximally tolerated statin therapy (1). Vascepa already had FDA approval for hypertriglyceridemia in people with triglycerides of 500 mg/dL or above. This newest approval expands FDA approval of Vascepa to people who meet the following criteria (1):

-Serum triglycerides of 150 mg/dL or higher AND

-Established cardiovascular disease OR

-Diabetes and at least two additional cardiovascular risk factors

Vascepa at a dose of 2 grams twice daily was studied in the REDUCE-IT trial in patients with a history of cardiovascular disease or diabetes with other risk factors (2). The agent was used as an adjunct to statin therapy in patients with an LDL of 41 to 100 mg/dL. Patients had a baseline fasting serum triglyceride level of 150 to 499 mg/dL. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization or unstable angina. Results showed that the primary endpoint occurred in 17.2% of patients in the Vascepa group versus 22% of patients in the control group. This difference was statistically significant with a hazard ratio of 0.75 in favor of Vascepa.

The mechanism behind Vascepa’s cardioprotective effects is not completely understood at this time (1). However, high serum triglycerides have been linked to atherosclerosis. Further, a slightly higher bleeding risk in Vascepa patients in the REDUCE-IT trial suggested to the researches that an antithrombotic mechanism may play a role (2).

It is important to note that other prescription and over-the-counter fish oil preparations have not shown the same clinical benefit as Vascepa (2). This is possibly due to the fact that other fish oil formulations contain a mixture of both docosahexaenoic acid, or DHA, as well as eicosapentaenoic acid, or EPA. DHA has been shown to increase serum LDL levels, while EPA has not (2). As an FDA-approved EPA ethyl ester, Vascepa does not have a DHA component (3).

Vascepa is available in two different strengths, 0.5 gram and 1 gram (3). As hard gelatin capsules, they must be swallowed whole. Patients may take two of the 1 gram capsules twice a day. As these capsules are 25 millimeters in length, patients may instead elect to take four of the 0.5 gram capsules twice daily as they are smaller, 15 millimeters in length. Although not contraindicated in patients with a history of fish or shellfish allergies, Vascepa should be used with caution in this population as it is a fish oil-derived product.

References:

1) U.S. Food and Drug Administration. “FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups.” December 13, 2019. Accessed December 29, 2019. Retrieved from: https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups

2) Bhatt, Deepak L; et al. “Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.” The New England Journal of Medicine, January 3, 2019. Accessed December 29, 2019. Retrieved from: https://www.nejm.org/doi/full/10.1056/NEJMoa1812792

3) U.S. National Library of Medicine. “Vascepa.” September 20, 2019, Accessed December 29, 2019. Retrieved from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508