ICOSAPENT ETHYL CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- History of hypersensitivity to icosapent ethyl or to any of its components
- Not on a statin or unable to tolerate statins
- Severe NYHA Class IV congestive heart failure
- Severe renal insufficiency (e.g., creatinine clearance <30 mL/min) or on dialysis
- Severe comorbid non-cardiovascular condition(s) expected to limit life expectancy to <2 years
- Uncontrolled or poorly controlled diabetes (e.g., HGB A1C > 10 %)
Inclusion Criteria
- > 45 years of age with established cardiovascular disease (history of acute coronary syndrome, myocardial infarction, ischemic stroke and/or symptomatic peripheral arterial disease)
- Receiving a moderate to high dose statin (or maximally tolerated statin) and LDL is between 41 mg/dL and 100 mg/dL
- Fasting triglyceride level of > 150 mg/dL
- Secondary causes of hypertriglyceridemia have been considered and managed as appropriate before considering addition of icosapent ethyl
- Lifestyle and dietary changes have been discussed with the patient
Dosing & Administration
- Icosapent ethyl 2 grams twice daily
- Available in 500 mg capsules (4 caps twice daily) if capsule size is a problem for some patients
- Statin doses should be maximized (as tolerated) prior to adding icosapent ethyl
Concomitant Medication Management
- Patients on other omega-3 fatty acids, dietary supplements containing OM-3 FA, niacin or fibrates must stop these medications for at least 28 days prior
- If currently receiving niacin, fibrates or other OM-3 FA/supplements for reducing elevated triglyceride levels, consider stopping them and rechecking a fasting triglyceride level after 1-3 months to determine eligibility based upon repeat value
Secondary Cause & Lifestyle Management
- Manage secondary causes of hypertriglyceridemia: hypothyroidism, uncontrolled diabetes, nephrotic syndrome, alcohol abuse, obesity, metabolic syndrome, and medications (e.g., tamoxifen, oral estrogens, systemic corticosteroids, thiazide diuretics, non-cardioselective beta-blockers [except carvedilol], clozapine, olanzapine)
- Encourage lifestyle and dietary changes: adoption of a healthy diet, weight loss in obese patients, aerobic exercise, smoking cessation, limiting alcohol intake
Restrictions & Safety Warnings
- Use is restricted to patients meeting criteria for reducing cardiovascular risk; evidence does not support a greater triglyceride lowering response between various fish oil products and icosapent ethyl
- For patients with severe hypertriglyceridemia > 500 mg/dL who do not meet CFU for reducing CV risk, refer to the Omega-3-Acid Ethyl Esters (Lovaza and Lovaza generics) CFU
- Statistically higher incidence of hospitalization for atrial fibrillation or flutter reported in the icosapent ethyl group versus placebo-mineral oil
- Trend towards a higher risk of serious bleeding events reported with icosapent ethyl vs placebo