The patient states adherence with healthy lifestyle and medications. During the clinician-patient discussion, she states that she is willing to take additional medications with proven cardiovascular risk reduction benefits.
Which of the following medications may be considered at this time for this patient?
The correct answer is: B. Icosapent ethyl 2 grams PO twice daily.
This patient's characteristics closely match the inclusion criteria (diabetes requiring treatment with medication, age ≥50 years and one additional risk factor) for the patients with diabetes that were included in the Reduction of Cardiovascular Events With EPA - Intervention Trial (REDUCE-IT). She is taking metformin for diabetes, is 52 years of age, and she has hypertension and HDL-C < 50 mg/dL. Her LDL-C is between 41-100 mg/dL, and her triglycerides are between 135-499 mg/dL. She is on a stable statin dose. In the REDUCE-IT trial, the group that received icosapent ethyl 2 grams twice daily was superior to placebo in reducing the primary composite cardiovascular (CV) endpoint (CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) and secondary composite CV endpoint (CV death, nonfatal MI, or nonfatal stroke) when compared to placebo among patients with elevated triglycerides and either clinical ASCVD or patients with diabetes and risk for developing ASCVD.1
Option A is an incorrect choice. Fenofibrate has not been shown to reduce CV events when combined with statin therapy.2,3
Option C is an incorrect choice. Dietary supplement products are not intended to treat, diagnose, prevent, or cure diseases. Omega-3 supplements should not be substituted for prescription omega-3 products. The prescription omega-3 products have demonstrated safety and effectiveness in lowering triglycerides. However, the FDA does not evaluate the safety or effectiveness of dietary supplements, including fish oil supplements. In addition, the potency, purity, shelf life, and quality of dietary supplements is not tightly regulated. The amount of active ingredients in dietary supplements is variable between products. There may also be some differences in tolerability between FDA approved prescription products and the supplements. The omega-3 supplements have been frequently associated with gastrointestinal side effects, like burping, fish taste, and dyspepsia. The labeling of the omega-3 supplements may also be confusing to patients and clinicians. The amount of fish oil listed on the front of a supplement bottle may not accurately reflect the total amount of long-chain omega-3 fatty acids, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in each capsule. It is common for fish oil supplements with 1000 mg listed on the front of the bottle to only contain 300 mg of the combined total of EPA and DHA in each capsule. For this particular fish oil supplement, the patient would have to take 14 capsules to get at least 4000 mg of the combined total of EPA and DHA. In contrast, the FDA evaluated the prescription strength omega-3 products for safety and efficacy. Each prescription strength omega-3 capsule has the designated amount of EPA or combination of EPA and DHA that is in the product labeling.4
Option D is an incorrect choice. Niacin has not been shown to reduce CV events when combined with statin therapy.5,6
Please note that all authors affiliated with this educational content did not accept honoraria for their participation in this grant.
Educational grant support provided by: Amarin.
To visit the hub for the CV Risk Beyond LDL Grant, click here!
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
Keech A, Simes RJ, Barter P, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 2005;366:1849-61.
Group AS, Ginsberg HN, Elam MB, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74.