Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial
Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH
Journal of clinical lipidology · 176 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
- 2013-10-15 · J Clin Lipidol · vol. 8 · número 1 · págs. 94–106
- Editorial
- Elsevier BV
- Citado
- 233 citas · más que el 100% de estudios similares · 20.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 68 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · Lipid metabolism and disorders · Lipoproteins and Cardiovascular Health
- Palabras clave
- severe hypertriglyceridemia, eicosapentaenoic acid, docosahexaenoic acid, triglyceride lowering, olive oil, lipid-lowering efficacy, LDL cholesterol, non-HDL cholesterol, apolipoprotein C-III, lipoprotein-associated phospholipase A2, C-reactive protein
- MeSH
- humans, hypertriglyceridemia, fatty acids, omega-3, triglycerides, treatment outcome, endpoint determination, middle aged, female, male
8 autores
- John J.P. Kastelein🇳🇱 · autor de correspondenciaAmsterdam UMC Location University of Amsterdam; University of Amsterdam
- Kevin Carl Maki🇺🇸BioFortis (United States)
- Andrey V. Susekov
- Ежов Марат Владиславович
- Børge Grønne Nordestgaard🇩🇰University of Copenhagen; Copenhagen University Hospital
- Ben N. Machielse
- Douglas F. Kling
- Michael H. Davidson
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Omega-3 fatty acids in free fatty acid form have enhanced bioavailability, and plasma levels are less influenced by food than for ethyl ester forms.
Objective
The aim was to evaluate the safety and lipid-altering efficacy in subjects with severe hypertriglyceridemia of an investigational pharmaceutical omega-3 free fatty acid (OM3-FFA) containing eicosapentaenoic acid and docosahexaenoic acid.
Methods
This was a multinational, double-blind, randomized, out-patient study. Men and women with triglycerides (TGs) ≥ 500 mg/dL, but <2000 mg/dL, took control (olive oil [OO] 4 g/d; n = 99), OM3-FFA 2 g/d (plus OO 2 g/d; n = 100), OM3-FFA 3 g/d (plus OO 1 g/d; n = 101), or OM3-FFA 4 g/d (n = 99) capsules for 12 weeks in combination with the National Cholesterol Education Program Therapeutic Lifestyle Changes diet.
Results
Fasting serum TGs changed from baseline by -25.9% (P < .01 vs OO), -25.5% (P < .01 vs OO), and -30.9% (P < .001 vs OO) with 2, 3, and 4 g/d OM3-FFA, respectively, compared with -4.3% with OO. Non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol-to-HDL-C ratio, very low-density lipoprotein cholesterol, remnant-like particle cholesterol, apolipoprotein CIII, lipoprotein-associated phospholipase A2, and arachidonic acid were significantly lowered (P < .05 at each OM3-FFA dosage vs OO); and plasma eicosapentaenoic acid and docosahexaenoic acid were significantly elevated (P < .001 at each OM3-FFA dosage vs OO). With OM3-FFA 2 and 4 g/d (but not 3 g/d), low-density lipoprotein cholesterol was significantly increased compared with OO (P < .05 vs OO). High-sensitivity C-reactive protein responses with OM3-FFA did not differ significantly from the OO response at any dosage. Fewer subjects reported any adverse event with OO vs OM3-FFA, but frequencies across dosage groups were similar. Discontinuation due to adverse event, primarily gastrointestinal, ranged from 5% to 7% across OM3-FFA dosage groups vs 0% for OO.
Conclusions
OM3-FFA achieved the primary end point for TG lowering and secondary end point of non-HDL-C lowering at 2, 3, and 4 g/d in persons with severe hypertriglyceridemia. This trial was registered at www.clinicaltrials.gov as NCT01242527.
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