Treatment with omega-3 polyunsaturated fatty acids does not improve endothelial function in patients with type 2 diabetes and very high cardiovascular risk: A randomized, double-blind, placebo-controlled study (Omega-FMD)

• Published in: Atherosclerosis 2018-04, Vol.271, p.148-155
• Main Authors: Siniarski, Aleksander, Haberka, Maciej, Mostowik, Magdalena, Gołębiowska-Wiatrak, Renata, Poręba, Małgorzata, Malinowski, Krzysztof Piotr, Gąsior, Zbigniew, Konduracka, Ewa, Nessler, Jadwiga, Gajos, Grzegorz
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Atherosclerosis; Atherosclerosis - diagnosis; Atherosclerosis - drug therapy; Atherosclerosis - physiopathology; Beverages; Brachial Artery - diagnostic imaging; Brachial Artery - drug effects; Brachial Artery - physiopathology; Cardiovascular disease; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - physiopathology; Dietary Supplements - adverse effects; Docosahexaenoic Acids - administration & dosage; Docosahexaenoic Acids - adverse effects; Docosahexaenoic Acids - blood; Double-Blind Method; Eicosapentaenoic Acid - administration & dosage; Eicosapentaenoic Acid - adverse effects; Eicosapentaenoic Acid - blood; Endothelium, Vascular - diagnostic imaging; Endothelium, Vascular - drug effects; Endothelium, Vascular - physiopathology; Female; Flow-mediated dilation; Humans; Male; Middle Aged; Omega-3 polyunsaturated fatty acids; Poland; Prospective Studies; Recovery of Function; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Type 2 diabetes; Vasodilation - drug effects
• ISSN: 0021-9150; 1879-1484
• DOI: 10.1016/j.atherosclerosis.2018.02.030

Numerous recent studies conducted in different clinical settings have focused on the benefits of omega-3 polyunsaturated fatty acids (n-3 PUFAs) in the prevention of cardiovascular diseases. There is limited evidence that patients with type 2 diabetes (T2D) and very high cardiovascular risk can also benefit from a high dose of n-3PUFAs, especially those on optimal medical therapy as recommended by the guidelines. The aim of the present study was to assess the impact of high-dose n-3 PUFA treatment on endothelial function in patients with T2D and established atherosclerotic cardiovascular disease (ASCVD). We conducted a prospective randomized double-blind, placebo-controlled, 2-center study, in which endothelial function was measured using flow-mediated dilation (FMD) and nitroglycerin-mediated dilation (NMD). Serum fatty acids composition was measured by gas chromatography. All measurements were done at baseline and after 3 months of treatment with PUFAs at a dose of 2 g/d (n = 36) or placebo (n = 38). The majority of the study population was treated with optimal medical therapy. Despite significantly higher concentrations of eicosapentaenoic acid (EPA) and docosahexaenoic acid in the n-3 PUFA group after 3-month treatment, we did not observe significant changes in endothelial function indices (FMD and NMD). However, in regression analysis, only baseline FMD was associated with EPA concentration before 3 months of n-3 PUFA treatment. Three months of high-dose n-3 PUFA treatment in very high-risk patients with ASCVD and T2D did not improve the endothelial function indices. •High-dose PUFA treatment did not influence the endothelium function.•No effect of high-dose PUFA was found for flow-mediated dilatation.•No effect of high-dose PUFA was found also for nitroglycerin-mediated dilatation.•FMD in PUFA group was significantly associated with hsCRP.•High-dose (2 g/day) PUFA treatment was found safe for our patients.