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This is a combination of two active pharmaceutical ingredients: - **Omega-3-acid ethyl esters** are a mixture of ethyl esters of the omega−3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), derived from fish oil. They are primarily used as an adjunct to diet to reduce very high triglyceride levels in adults, which may help lower the risk of pancreatitis and cardiovascular events. The mechanism involves reducing hepatic triglyceride synthesis, increasing fatty acid metabolism, inhibiting release of fatty acids, and enhancing triglyceride clearance[4][5][6]. - **Raloxifene** is a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist on bone and lipid metabolism but as an antagonist on breast and uterine tissue. It is approved for prevention and treatment of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer in high-risk postmenopausal women[8]. The combination has been studied for potential chemopreventive effects against breast cancer due to their complementary mechanisms—raloxifene targeting estrogen receptor pathways, while omega-3-acid ethyl esters may inhibit multiple proliferative pathways including those interacting with estrogen signaling[1][3]. This strategy has shown feasibility in clinical studies but is not currently marketed as a fixed-dose combination.
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