Financiado en parte por AstraZeneca, Novo Nordisk Fonden
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
Oscarsson J, Önnerhag K, Risérus U, Sundén M, Johansson L, Jansson PA, Moris L, Nilsson PM, Eriksson JW, Lind L
Journal of clinical lipidology · 99 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- AstraZeneca
- Empresa
- Novo Nordisk Fonden
- Subvenciones
- Novo Nordisk Fonden (NNF17OC0027458)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2018-08-10 · J Clin Lipidol · vol. 12 · número 6 · págs. 1390–1403.e4
- Editorial
- Elsevier BV
- Citado
- 112 citas · más que el 97% de estudios similares · 5.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 61 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Liver Disease Diagnosis and Treatment · Fatty Acid Research and Health · Lipid metabolism and disorders
- Palabras clave
- fenofibrate, non-alcoholic fatty liver disease, hypertriglyceridemia, liver fat, proton density fat fraction, serum triglycerides, docosahexaenoic acid, delta-9 desaturase, F2-isoprostanes, liver volume
- MeSH
- liver, pancreas, adipose tissue, hepatocytes, humans, hypertriglyceridemia, body weight, carboxylic acids, blood glucose, fatty acids, omega-3, lipoproteins, placebos, treatment outcome, double-blind method, oxidative stress, adult, aged, middle aged, female, male, fenofibrate, non-alcoholic fatty liver disease
10 autores
- Jan Oscarsson · autor de correspondencia
- Kristina Önnerhag🇸🇪Lund University
- Ulf Risérus🇸🇪Uppsala University
- Mattias Sundén
- Lars Johansson🇸🇪Antaros Medical (Sweden)
- Per‐Anders Jansson🇸🇪University of Gothenburg
- Linda Moris🇸🇪Karolinska University Hospital
- Peter M. Nilsson🇸🇪Lund University
- Jan W. Eriksson🇸🇪Uppsala University
- Lars Lind🇸🇪Uppsala University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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