Abstract
Background: Omega-3 polyunsaturated fatty acids (PUFAs) have some protective benefits for patients with coronary artery and cerebrovascular diseases. Eicosapentaenoic acid (EPA) drugs are prescribed as branded (B: EPADEL?) or generic products but no data exist concerning the differences in treatment outcomes between these products. Methods and Results: We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL? and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. After 6 months of administration, EPADEL? produced better results than the generic (G) product (EPA; baseline: 59.4 ± 25.5 μg, B: 215.5 ± 58.8 μg, G: 199.7 ± 63.8 μg, B vs G, p μg, B: 158.3 ± 36.3 μg, G: 163.6 ± 38.9 μg, B vs G, p Conclusions: There were clear differences between EPA branded and the generic products. Further study is required to determine whether the benefits from the branded product justify the higher price compared to the generic drug cost.
Highlights
The observational study in Greenland Eskimos had shown that they had high plasma level of eicosapentaenoic acid (EPA) and low plasma level of arachidonic acid (AA) and had a low incidence of myocardial infarction [1]
We investigated the differences in the serum levels of Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL® and a generic EPA drug was initiated for 96 patients with cardiovascular diseases
In the evaluation of the 66 patients who took both products under the same statin dosage, the alteration of EPA levels was equivalent to the alteration among the overall 96 patients and there was no difference in the reduction in AA levels between the branded and generic products (Figure 4 and Figure 5)
Summary
The observational study in Greenland Eskimos had shown that they had high plasma level of eicosapentaenoic acid (EPA) and low plasma level of arachidonic acid (AA) and had a low incidence of myocardial infarction [1]. We investigated the differences in EPA, DHA, AA and the EPA/AA ratio through blood sampling six months after daily administration of EPADEL® and a generic EPA product (released by a drug company) was initiated in patients with cardiovascular diseases. Methods and Results: We investigated the differences in the serum levels of EPA, docosahexaenoic acid (DHA) and arachidonic acid (AA), and the EPA/AA ratios through blood sampling six months after daily administration of 1800 mg of EPADEL® and a generic EPA drug was initiated for 96 patients with cardiovascular diseases. All patients received these PUFA treatments while continuing with baseline therapy. Further study is required to determine whether the benefits from the branded product justify the higher price compared to the generic drug cost
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