Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial

Journal of Clinical Lipidology
Harold E BaysJohn J P Kastelein

Abstract

Icosabutate is a structurally enhanced omega-3 fatty acid molecule developed with the aim of achieving improved triglyceride (TG)-lowering efficacy, increased potency, and preserved safety compared with conventional prescription omega-3 fatty acid. To evaluate the efficacy and safety of icosabutate 600 mg once daily in patients with very high TGs. After a 6-8 week run-in period, men and women with TG levels ≥ 500 mg/dL and ≤ 1500 mg/dL were randomized to double-blind treatment with placebo or icosabutate 600 mg for 12 weeks. The primary end point was % change from baseline in TGs at 12 weeks. A total of 87 subjects were randomized. At baseline, median TG (interquartile range) levels were 611 (543-878) and 688 (596-892) mg/dL, and the median change after 12 weeks of treatment was -51% and -17%, respectively, for a placebo-corrected change of -33% (P < .001). Adjusted for placebo, icosabutate significantly reduced very low-density lipoprotein cholesterol (-36%, P < .001), remnant lipoprotein cholesterol (-34%, P < .001), apolipoprotein (Apo) C-III (-35%, P < .001), trended toward reduced non-high-density lipoprotein cholesterol (-7%, P = .064); significantly increased high-density lipoprotein cholesterol (18%, P < .001) and low-d...Continue Reading

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Citations

Apr 4, 2017·Expert Opinion on Investigational Drugs·Gerald H Tomkin, Daphne Owens
May 27, 2017·Current Opinion in Lipidology·Anette Varbo, Børge G Nordestgaard
Aug 26, 2020·Liver International : Official Journal of the International Association for the Study of the Liver·Geurt StokmanDavid A Fraser
Apr 1, 2021·The Journal of Nutritional Biochemistry·Zhao YangMichael C Petriello

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