A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial)
Maki KC, Orloff DG, Nicholls SJ, Dunbar RL, Roth EM, Curcio D, Johnson J, Kling D, Davidson MH
Clinical therapeutics · 78 citas
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 independiente
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (K23HL091130)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2013-08-30 · Clin Ther · vol. 35 · número 9 · págs. 1400–1411.e3
- Editorial
- Elsevier BV
- Citado
- 104 citas · más que el 99% de estudios similares · 11.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Lipid metabolism and disorders
- Palabras clave
- omega-3 fatty acids, hypertriglyceridemia, statin therapy, ezetimibe, cardiovascular risk, non-HDL cholesterol, triglycerides, LDL cholesterol, apolipoproteins, eicosapentaenoic acid, docosahexaenoic acid, docosapentaenoic acid, arachidonic acid, olive oil placebo
- MeSH
- humans, cardiovascular diseases, hypertriglyceridemia, fatty acids, omega-3, fatty acids, nonesterified, triglycerides, plant oils, hydroxymethylglutaryl-coa reductase inhibitors, combined modality therapy, drug therapy, combination, drug administration schedule, risk factors, double-blind method, biological availability, dietary supplements, aged, middle aged, cholesterol, hdl, medication adherence, olive oil
9 autores
- Kevin Carl Maki🇺🇸 · autor de correspondenciaBioFortis (United States)
- David G. Orloff🇺🇸Medpace (United States)
- Stephen James Nicholls🇦🇺South Australian Health and Medical Research Institute
- Richard L. Dunbar🇺🇸University of Pennsylvania
- Eli M. Roth🇺🇸Sterling Research Group
- Danielle L. Curcio
- Judith Johnson
- Douglas F. Kling
- Michael H. Davidson
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia.
Objective
This study was designed to evaluate the efficacy of adding OM3-FFA (2 or 4 g/d) to statin therapy for lowering non-HDL-C and TG levels in subjects with persistent hypertriglyceridemia and at high risk for cardiovascular disease.
Methods
In this double-blind, parallel-group study, 647 diet-stable patients with fasting TG levels ≥ 200 mg/dL and <500 mg/dL (treated with a maximally tolerated dose of statin or statin with ezetimibe) and at high risk for cardiovascular disease were randomized to 6 weeks of treatment with capsules of control (olive oil [OO]) 4 g/d, OM3-FFA 2 g/d (plus 2 g/d OO), or OM3-FFA 4 g/d. Assessments included fasting serum levels of lipids and apolipoproteins (apo); plasma concentrations of eicosapentaenoic acid, docosahexaenoic acid, docosapentaenoic acid, and arachidonic acid; and laboratory safety values and adverse events.
Results
In the 627 subjects in the intention to treat sample, non-HDL-C levels were reduced with OM3-FFA 2 g/d and OM3-FFA 4 g/d (-3.9% and -6.9%, respectively) compared with OO (-0.9%) (both, P < 0.05), as were TG levels (-14.6% and -20.6%, respectively, vs -5.9%; both, P < 0.001). LDL-C levels increased with OM3-FFA 2 g/d (4.6%) compared with OO (1.1%) (P = 0.025) but not with OM3-FFA 4 g/d (1.3%). Total cholesterol and VLDL-C concentrations were reduced compared with OO with both OM3-FFA dosages, and the total cholesterol/HDL-C ratio and apo AI and apo B levels were significantly lowered with OM3-FFA 4 g/d only (all at least P < 0.05). Percent changes from baseline in HDL-C did not differ between OO and either OM3-FFA group. Plasma concentrations of docosahexaenoic acid, eicosapentaenoic acid, and docosapentaenoic acid were significantly increased and arachidonic acid was significantly reduced in both OM3-FFA treatment groups compared with the OO responses (all, P < 0.001). Withdrawals related to treatment-emergent adverse events ranged from 0.9% with OO to 3.2% with OM3-FFA 4 g/d.
Conclusions
OM3-FFA was well tolerated and lowered non-HDL-C and TG levels at both 2- and 4-g/d dosages in patients with persistent hypertriglyceridemia taking a statin, with the 4-g/d dosage providing incremental improvements compared with 2 g/d.
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