RX & OTC Update

Icosapent Ethyl

Modified omega-3 fatty acid to treat severe hypertriglyceridemia.

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Icosapent ethyl (Vascepa), approved for treatment of severe hypertriglyceridemia (TRIG > 500 mg/dL), is a long-chain omega-3 fatty acid form of eicosapentaenoic acid (EPA).1 One rationale for developing it was to create a pure EPA ethyl ester product. Omega-3 fatty acids are available in fish oils and modified omega-3 fatty acids (Lovaza) containing EPA and docosahexaenoic acid (DHA), which studies tie to increases in LDL-cholesterol.2

Very high levels of triglycerides (see Table 1) can cause pancreatitis and require immediate control. Patients with diabetes mellitus and metabolic syndrome often have hypertriglyceridemia and are at high cardiovascular risk.3 Treatment includes diet, exercise and reducing alcohol consumption.

Drug therapy for managing lipid disorders lowers LDL-cholesterol as a primary target, followed by non-HDL cholesterol. Statins, niacin or a combination are used for treatment of hypertriglyceridemia.3 Once LDL-cholesterol is controlled, if triglycerides are above 200 mg/dL, lowering can be achieved with statin plus niacin or statin plus fibrate; however, these combinations can increase risk for myopathy.

Research

The MARINE trial included 229 adults with fasting triglycerides between 500 mg/dL and 2,000 mg/dL at baseline. The trial excluded subjects with recent ischemic heart disease events, morbidly obese, pancreatitis, or poorly controlled diabetes or thyroid disease. The subjects' mean age was 53 years, and all had very high triglycerides > 750 mg/dL (39%), obesity (mean BMI 30.8 kg/m2) and diabetes mellitus (28%).4

Icosapent ethyl significantly reduced the placebo-corrected median percent change in triglycerides from baseline to end of study by 33.1% in the 4 g per day group (p < 0.0001) and by 19.7% in the 2 g per day group (p = 0.0051). Similar effects were observed in subjects with the highest triglyceride levels (> 750 mg/dL).4

The ANCHOR trial used the same design to evaluate patients at high risk for coronary heart disease (CHD).5 The trial included subjects taking statins with controlled LDL-cholesterol (> 40 mg/dL to < 100 mg/dL) but who had high triglyceride levels (> 200 mg/dL to < 500 mg/dL). The icosapent ethyl arm significantly reduced the placebo-corrected median percent change in triglycerides from baseline to end of study by 21.5% in the 4 g per day group (p < 0.0001) and by 10.1% in the 2 g per day group (p = 0.005). Both trials underreported adverse events from the screening and washout period.

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Icosapent ethyl has been evaluated in patients with combined lipid disorders at moderate risk to high risk for coronary events and is indicated as an adjunct to diet for management of hypertriglyceridemia.1 It is not approved for the management of patients with pancreatitis nor to prevent CHD events. The REDUCE-IT trial is enrolling high-risk patients with hypertriglyceridemia receiving a statin to examine if icosapent ethyl will have a meaningful effect on lowering inflammatory mediators and lowering coronary heart disease events.6

Mechanism of Action

Icosapent ethyl inhibits hepatic synthesis and clearance of very low-density lipoprotein triglycerides.2 EPA may prevent CHD by promoting plaque stabilization by inhibiting the damaging effects of macrophages.7

Dosage, Costs, Pharmacokinetics

Icosapent ethyl is available by prescription, which is 2 g capsules twice daily with food. The average whole price is estimated at $55 monthly.8

The drug is absorbed in the small intestine and reaches a peak plasma concentration within five hours.1 It is highly protein-bound (99%), predominantly eliminated by hepatic metabolism and is a minor substrate for the cytochrome P450 enzyme pathway.

Drug Interactions & Side Effects

Drug interactions with antiplatelets have potential to prolong bleeding time, however, there was no interaction with warfarin (Coumadin). Patients should be monitored for bleeding or bruising if taking antiplatelet drugs such as aspirin, NSAIDs, P2Y12 inhibitors (clopidogrel, Plavix) and glycoprotein IIb IIIa inhibitors (abciximab, ReoPro). Several medications may worsen hypertriglyceridemia (beta-blockers, thiazide diuretics, estrogens).

The most common side effect is arthralgia (icosapent 2.3 percent, placebo 3 percent).1 Side effects experienced by more than 3% of subjects in one study (> 400) were diarrhea, nausea, nasopharyngitis and arthralgia. Belching was reported infrequently.5 One patient receiving the 4 g dose reported an increase in hepatic ALT > 3 times the upper limit of normal at 12 weeks.

Monitoring

Advise patients to report joint pain and persistent gastrointestinal complaints such as diarrhea and nausea. Monitor baseline fasting lipid panel and then repeat no sooner than every 6 weeks. Hepatic ALT and AST levels should be monitored in patients with liver impairment. 

References for this article can be accessed here.

Grace Earl is an ambulatory care Pharmacist at the University of the Sciences and her practice site is at the Center for Advanced Heart Failure Care at Hahnemann University Hospital, Philadelphia.

ICOSAPENT ETHYL AT A GLANCE

Overview
• Drug class: form of omega-3 fatty acid
• Drug action: lower triglycerides

Indications
• An adjunct to diet to treat severe hypertriglyceridemia
• Triglycerides over > 500 mg/dL

Contraindications
• Known hypersensitivity to icosapent ethyl capsules
• Known hypersensitivity to EPA components


RX and OTC Updates Archives
  Last Post: February 2, 2013 | View Comments(2)

Hyperlipidemia a Non-illness? Cholesterol a Hoax? Tell that to the mother of a skinny ten year old who recently had a mild stroke to go along with his hyperlipidemia >800 and hypertension. He is currently off meds altogether due to dietary changes. Although statins do carry risks (as does any drug)and should be used only as a last line of defense after lifestyle/diet changes then other non-statins, the drug being discussed in this article is not even a statin or recommended except in cases of extremely high levels >500.

TJ February 02, 2013



another unnecessary drug for treatment of non-illness, has not the whole cholesterol and statin hoax taught us anything... why are we not being advocates for our patients and telling them that true research shows these drugs are dangerous and make no real difference in your health or longevity

steven buckman,  RNJanuary 27, 2013
VA




     

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