Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of t
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ORIGINAL RESEARCH
Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia Tamio Teramoto . Hirotaka Shibata . Yuki Suzaki . Shingo Matsui . Naoto Uemura . Hirofumi Tomiyama . Akira Yamashina Received: January 15, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (LotrigaÒ, Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD). Methods: Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.11920131. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01286-1) contains supplementary material, which is available to authorized users. T. Teramoto Teikyo Academic Research Center, Teikyo University, Tokyo, Japan H. Shibata N. Uemura Faculty of Medicine, Oita University, Oita, Japan Y. Suzaki (&) S. Matsui Takeda Pharmaceutical Company Limited, Tokyo, Japan e-mail: [email protected] H. Tomiyama A. Yamashina Department of Cardiology, Tokyo Medical University, Tokyo, Japan
randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting %FMD in each treatment group. Secondary end points included the 4-h postprandial %FMD and 4-h postprandial triglyceride (TG) level. Results: Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p \ 0.001). No new safety concerns were identified. Conclusions: Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group. Trial Registration: ClinicalTrials.gov, ID: NCT02824432. Keywords: Dyslipidemia; Flow-mediated dilation; Hyperlipidemia; LotrigaÒ; Omega-3 fatty acid ethyl esters; Triglyceridemia; Vascular endothelial function
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Key Summary Points Why carry out this study? Omega-3 fatty acid ethyl esters (omega-3) are approved in Japan for the treatment of triglyceridemia and have been shown to improve (i.e., increase) flow-mediated dilation (FMD); however, the correlation between changes in FMD and trigly
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