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Appendix C – Drug Companion Document – Ethyl Esters of Omega-3 Fatty Acids

Efficacy

    Indicated for adjunct to diet in adults with very high triglyceride levels (greater than 500 mg/dL).

    Effects on cardiovascular mortality and morbidity in patients with very high triglyceride levels are unknown.
 
    Effects on the risk of pancreatitis in patients with very high triglyceride levels are unknown.

    Mean triglyceride decrease of 45%.
 
    Mean HDL-cholesterol increase of 13%.
 
    Mean LDL-cholesterol increase of up to 32%.
 
    The percent reductions and elevations are based on patients receiving fish oil 4 grams per day for four months.
 
    Withdraw treatment if inadequate response after two months of therapy.
 
    Effective in lowering serum triglycerides over one year in patients with CHD and combined hyperlipidaemia whose triglycerides remained
      elevated despite simvastatin treatment.
 
    As effective as gemfibrozil in reducing serum triglyceride levels.
 

Safety

    Use caution in patients with a history of sensitivity or allergy to fish.

    Pregnancy category C: Use in pregnant women only if the potential benefit justifies the potential risk to the fetus.
 
    Use caution in breast-feeding women, due to lack of human safety information.
 

Dosing

    The daily dose of fish oil should contain 4 g of EPA/DHA per day. The daily dose may be taken as a single 4 g dose or as two 2 g doses
      (2 grams given twice daily).
 
    Patients should be placed on a standard cholesterol-lowering diet before receiving omega-3-acid ethyl esters and should continue on this
     diet during treatment with omega-3-acid ethyl esters.

(Durrington, 2001 [A]; Harris, 1997 [A]; Lavie, 2009 [M]; Stalenhoef, 2000 [A])