ω-3 Fatty acids are therapeutic agents that can lower blood triglyceride levels, especially novel formulations with a higher bioavailability and more minor side effects. The incidence of obesity and type 2 diabetes, respectively, is associated with hypertriglyceridemia, especially in low to middle-income countries. Hypertriglyceridemia is associated with nephrotic syndrome, chronic renal insufficiency, hypothyroidism, and fatty liver.
ω-3-Phospholipid/free fatty acid (ω-3-PL/FFA) is a new therapy that contains krill oil with a new formulation of ω-3s as FFA and binds to phospholipids (PL) (ratio 50:50). Both have high absorption rates and high bioavailability. In the phase 2 study, ω-3-PL/FFA decreased triglyceride levels without increasing LDL-C in patients with high triglycerides.
A double-blind, placebo-controlled, randomized clinical trial phase 3, evaluated the efficacy and safety of ω-3-PL/FFA 4 g/day compared with placebo in adults >18 years of age with fasting triglyceride levels of 500-1500 mg/dL. The study involved about 520 subjects. Subjects were evaluated for diet, lifestyle, and medications consumed during the screening. Subjects received ω-3-PL/FFA, 4 g/day (1.24 g/day eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] as FFA or PL).
Subjects were evaluated four weeks after the stable dose was administered, 11, 12, 18, and 26 weeks. Physical examination evaluation, dietary counseling, blood examination, and urinalysis were carried out. The parameter to be measured is the percentage change in fasting triglyceride levels after 12 weeks.
Research result:
· At week 12, triglyceride levels decreased by 26% in the ω-3-PL/FFA group vs. 15% in the placebo group (p=0.02).
· At week 26, triglyceride levels decreased by 33.5% in the ω-3-PL/FFA group vs. 20.8% in the placebo group (p=0.02).
· Compared with the placebo group, ω-3-PL/FFA found no significant difference in non-HDL-C, VLDL-C, HDL-C, LDL-C parameters at weeks 12 and 26.
· At week 12, 210 of 372 subjects (56.6%) in the ω-3-PL/FFA group and 68 of 148 subjects (45.90%) in the placebo group achieved the target triglyceride level below 500 mg/kg. dL.
Conclusion:
ω-3-PL/FFA, krill oil derivative formula ω-3 can reduce triglyceride levels and is safe and well-tolerated by patients with severe hypertriglyceridemia.
Image: Illustration (Source: Freepik)
Reference:
Mozaffarian D, Maki KC, Bays HE, Aguilera F, Gould G, Hegele RA, et al. Effectiveness of a novel -3 krill oil agent in patients with severe hypertriglyceridemia: A randomized clinical trial. JAMA Netw Open. 2022;5(1):e2141898.
