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Effects of free omega-3 carboxylic acids and fenofibrate on liver fat content in patients with hypertriglyceridemia and non-alcoholic fatty liver disease: A double-blind, randomized, placebo-controlled study
AstraZeneca Gothenburg, Pepparedsleden 1, S-43183 Molndal, Sweden.
Lund Univ, Dept Clin Sci, Malmo, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism.ORCID iD: 0000-0002-8620-4586
AstraZeneca Gothenburg, Pepparedsleden 1, S-43183 Molndal, Sweden.
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2018 (English)In: Journal of Clinical Lipidology, ISSN 1933-2874, E-ISSN 1876-4789, Vol. 12, no 6, p. 1390-1403Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Treatment with omega-3 fatty acids and fenofibrates reduces serum triglyceride levels, but few studies have compared the effect of these agents on liver fat. OBJECTIVE: The aim of the EFFECT I trial (NCT02354976) was to determine the effects of free omega-3 carboxylic acids (OM-3CA) and fenofibrate on liver fat in overweight or obese individuals with non-alcoholic fatty liver disease and hypertriglyceridemia. METHODS: Seventy-eight patients were randomized to receive oral doses of 4 g OM-3CA (n = 25), 200 mg fenofibrate (n = 27), or placebo (n = 26) for 12 weeks in a double-blind, parallel-group study. Liver proton density fat fraction (PDFF) and volume, pancreas volume, and adipose tissue volumes were assessed by magnetic resonance imaging. RESULTS: Changes in liver PDFF at 12 weeks were not significantly different across treatment groups (relative changes from baseline: placebo, +4%; OM-3CA, -2%; and fenofibrate, +17%). The common PNPLA3 genetic polymorphism (I148M) did not significantly influence the effects of OM-3CA or fenofibrate on liver PDFF. Fenofibrate treatment significantly increased liver and pancreas volumes vs placebo treatment, and the changes in liver and pancreas volumes were positively correlated (rho 0.45, P = .02). Total liver fat volume increased significantly in patients using fenofibrate vs OM-3CA (+23% vs 3%, P = .04). Compared with OM-3CA, fenofibrate increased total liver fat and liver volume. Serum triglycerides decreased with OM-3CA (-26%, P = .02) and fenofibrate (-38%, P < .001) vs placebo. In contrast to OM-3CA, fenofibrate reduced plasma docosahexaenoic acid levels and increased plasma acetylcarnitine and butyrylcarnitine levels, estimated delta-9 desaturase activity and the concentration of urine F2-isoprostanes. CONCLUSIONS: OM-3CA and fenofibrate reduced serum triglycerides but did not reduce liver fat. Fenofibrate increased total liver volume and total liver fat volume vs OM-3CA, indicating a complex effect of fenofibrate on human hepatic lipid metabolism.

Place, publisher, year, edition, pages
2018. Vol. 12, no 6, p. 1390-1403
Keywords [en]
Cholesterol, Fatty liver disease, Lipoproteins, Liver, Non-alcoholic fatty liver disease, Omega-3 fatty acids, Pancreas, PPARs, Triglycerides
National Category
Gastroenterology and Hepatology Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:uu:diva-374128DOI: 10.1016/j.jacl.2018.08.003ISI: 000454674600009PubMedID: 30197273OAI: oai:DiVA.org:uu-374128DiVA, id: diva2:1280373
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AstraZenecaAvailable from: 2019-01-18 Created: 2019-01-18 Last updated: 2019-01-18Bibliographically approved

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