TITLE:
Fatty Acid Treatment with Pure Omega-3 Eicosapentaenoic Acid Ethyl Ester for Patients with Cardiovascular Diseases: Differences between Branded (EPADEL®) and Generic Products
AUTHORS:
Michihiro Suwa, Isao Morii, Masaya Kino
KEYWORDS:
Eicosapentaenoic Acid (EPA), Arachidonic Acid (AA), Docosahexaenoic Acid (DHA), Omega-3 Polyunsaturated Fatty Acids, Branded Product, Generic Product
JOURNAL NAME:
Food and Nutrition Sciences,
Vol.11 No.10,
October
15,
2020
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.