Financiado en parte por Amarin Pharma
Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies
Ballantyne CM, Bays HE, Philip S, Doyle RT, Braeckman RA, Stirtan WG, Soni PN, Juliano RA
Atherosclerosis · 39 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- Gobierno
- U.S. Food and Drug Administration
- Empresa
- Amarin Pharma
Según 2 financiadores declarados.
Publicación
- Publicado
- 2016-08-23 · Atherosclerosis · vol. 253 · págs. 81–87
- Editorial
- Elsevier BV
- Citado
- 52 citas · más que el 94% de estudios similares · 4.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 44 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC-ND
- Áreas de investigación
- Fatty Acid Research and Health · Antioxidant Activity and Oxidative Stress · Diabetes, Cardiovascular Risks, and Lipoproteins
- Palabras clave
- Eicosapentaenoic acid, Triglyceride, Placebo, Internal medicine, Statin, Ethyl ester, Medicine, Cholesterol, Endocrinology, Fatty acid, Chemistry, Biochemistry, Polyunsaturated fatty acid, Pathology
- MeSH
- humans, cardiovascular diseases, hypertriglyceridemia, cholesterol, fatty acids, omega-3, eicosapentaenoic acid, triglycerides, lipoproteins, platelet aggregation inhibitors, hydroxymethylglutaryl-coa reductase inhibitors, data interpretation, statistical, double-blind method, adult, aged, middle aged, female, male, atherosclerosis, hypolipidemic agents
8 autores
- Christie Mitchell Ballantyne🇺🇸 · autor de correspondenciaHouston Methodist; Baylor College of Medicine
- Harold Edward Bays🇺🇸Louisville Metabolic and Atherosclerosis Research Center
- Sephy Philip🇺🇸Amarin (United States)
- Ralph T. Doyle🇺🇸Amarin (United States)
- Rene A. Braeckman🇺🇸Amarin (United States)
- William G. Stirtan🇺🇸Amarin (United States)
- Paresh N. Soni🇺🇸Amarin (United States)
- Rebecca A. Juliano🇺🇸Amarin (United States)
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background and aims
Remnant-like particle cholesterol (RLP-C) is atherogenic and may increase atherosclerotic cardiovascular disease risk. Icosapent ethyl is a high-purity prescription eicosapentaenoic acid ethyl ester (approved as an adjunct to diet to reduce triglyceride [TG] levels in adult patients with TGs ≥500 mg/dL [≥5.65 mmol/L] at 4 g/day). In the MARINE and ANCHOR studies, icosapent ethyl reduced TG and other atherogenic lipid parameter levels without increasing low-density lipoprotein cholesterol (LDL-C) levels. This exploratory analysis evaluated the effects of icosapent ethyl on calculated and directly measured RLP-C.
Methods
MARINE (TGs ≥500 and ≤2000 mg/dL [≥5.65 mmol/L and ≤22.6 mmol/L]) and ANCHOR (TGs ≥200 and <500 mg/dL [≥2.26 and <5.65 mmol/L] despite statin-controlled LDL-C) were phase 3, 12-week, double-blind studies that randomized adult patients to icosapent ethyl 4 g/day, 2 g/day, or placebo. This analysis assessed median percent change from baseline to study end in directly measured (immunoseparation assay) RLP-C levels (MARINE, n = 218; ANCHOR, n = 252) and calculated RLP-C levels in the full populations.
Results
Icosapent ethyl 4 g/day significantly reduced directly measured RLP-C levels -29.8% (p = 0.004) in MARINE and -25.8% (p = 0.0001) in ANCHOR versus placebo, and also reduced directly measured RLP-C levels to a greater extent in subgroups with higher versus lower baseline TG levels, in patients receiving statins versus no statins (MARINE), and in patients receiving medium/higher-intensity versus lower-intensity statins (ANCHOR). Strong correlations were found between calculated and directly measured RLP-C for baseline, end-of-treatment, and percent change values in ANCHOR and MARINE (0.73-0.92; p < 0.0001 for all).
Conclusions
Icosapent ethyl 4 g/day significantly reduced calculated and directly measured RLP-C levels versus placebo in patients with elevated TG levels from the MARINE and ANCHOR studies.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).
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