A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova(®) compared to Lovaza(®) in a pharmacokinetic single-dose evaluation) study
Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF
Journal of clinical lipidology · 145 citas
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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
- Financiación no declarada
Publicación
- Publicado
- 2012-01-24 · J Clin Lipidol · vol. 6 · número 6 · págs. 573–584
- Editorial
- Elsevier BV
- Citado
- 190 citas · más que el 99% de estudios similares · 12.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 26 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Aquaculture Nutrition and Growth · Drug Solubulity and Delivery Systems
- Palabras clave
- omega-3 fatty acids, omega-3 acid ethyl esters, eicosapentaenoic acid, docosahexaenoic acid, bioavailability, low-fat diet, high-fat diet, hypertriglyceridemia, pharmacokinetics, plasma fatty acid concentrations
- MeSH
- humans, hypertriglyceridemia, fatty acids, omega-3, docosahexaenoic acids, eicosapentaenoic acid, drug combinations, diet, fat-restricted, area under curve, prospective studies, cross-over studies, molecular structure, time factors, dietary supplements, adult, middle aged, female, male, overweight, young adult, diet, high-fat
5 autores
- Michael Davidson · autor de correspondencia
- Judith Johnson
- Michael W. Rooney🇺🇸Radiant Research (United States)
- Michael Kyle🇺🇸Radiant Research (United States)
- Douglas F. Kling
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Omega-3 (OM-3) fatty acid products are indicated for the treatment of severe hypertriglyceridemia; however, the omega-3-acid ethyl ester (OM-3 EE) formulations require significant pancreatic lipase stimulation with high-fat meals for adequate intestinal absorption of the metabolites eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). A novel omega-3 free fatty acid (OM-3 FFA) formulation (Epanova(®), Omthera Pharmaceuticals Inc., Princeton, NJ) was developed to maximize EPA and DHA bioavailability during a low-fat diet.
Objective
To compare the relative bioavailability of EPA and DHA from single 4-gram doses of OM-3 FFA and a prescription OM-3 EE (Lovaza(®), GlaxoSmithKline, Research Triangle Park, NC).
Methods
This was a randomized, open-label, single dose, 4-way crossover, bioavailability study of OM-3 FFA and OM-3 EE administered during periods of low-fat and high-fat consumption to 54 overweight adults. Bioavailability was determined by the ln-transformed area under the plasma concentration versus time curve (AUC(0-t)) during a 24-hour interval for EPA and DHA (baseline-adjusted).
Results
The baseline-adjusted AUC(0-t) for total EPA + DHA during the low-fat period was 4.0-fold greater with OM-3 FFA compared with OM-3 EE (2650.2 vs 662.0 nmol·h/mL, respectively; P < .0001). During the high-fat period, AUC(0-t) for OM-3 FFA was approximately 1.3-fold greater than OM-3 EE (P < .0001). During the low-fat period, 30 of 51 (58.8%) subjects dosed with OM-3 FFA maintained an AUC(0-t) that was ≥50% of the respective high-fat AUC(0-t) in contrast to only 3 of 50 (6.0%) subjects dosed with OM-3 EE.
Conclusions
During a low-fat consumption period, the OM-3 FFA formulation provided dramatically improved bioavailability over the OM-3 EE formulation in overweight subjects. These findings offer a potential therapeutic advantage of the OM-3 FFA formulation for the treatment of severe hypertriglyceridemia as these patients are expected to adhere to a low-fat diet.
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