Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial)
Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN
The American journal of cardiology · 278 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
- 2011-06-22 · Am J Cardiol · vol. 108 · número 5 · págs. 682–690
- Editorial
- Elsevier BV
- Citado
- 357 citas · más que el 100% de estudios similares · 22.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Lipid metabolism and disorders
- Palabras clave
- eicosapentaenoic acid ethyl ester, omega-3 fatty acids, hypertriglyceridemia, triglyceride lowering, LDL cholesterol, non-HDL cholesterol, apolipoprotein A-I, apolipoprotein B, lipoprotein(a), statin therapy, dose comparison, placebo-controlled
- MeSH
- humans, hypertriglyceridemia, eicosapentaenoic acid, placebos, hydroxymethylglutaryl-coa reductase inhibitors, body mass index, treatment outcome, double-blind method, middle aged, female, male
6 autores
- Harold Edward Bays🇺🇸 · autor de correspondenciaLouisville Metabolic and Atherosclerosis Research Center
- Christie Mitchell Ballantyne🇺🇸Baylor College of Medicine
- John J.P. Kastelein🇳🇱Amsterdam UMC Location University of Amsterdam
- Jonathan L. Isaacsohn🇺🇸Medpace (United States)
- Rene A. Braeckman🇺🇸Amarin (United States)
- Paresh N. Soni🇺🇸Amarin (United States)
Resumen
El texto original del estudio, en el idioma en que se publicó.
AMR101 is an omega-3 fatty acid agent containing ≥96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid. Previous smaller studies suggested that highly purified eicosapentaenoic acid lowered triglyceride (TG) levels without increasing low-density lipoprotein (LDL) cholesterol levels. TG-lowering therapies such as fibrates, and fish oils containing both eicosapentaenoic acid and docosahexaenoic acid, can substantially increase LDL cholesterol levels when administered to patients with very high TG levels (≥500 mg/dl). The present double-blind study randomized 229 diet-stable patients with fasting TG ≥500 mg/dl and ≤2,000 mg/dl (with or without background statin therapy) to AMR101 4 g/day, AMR101 2 g/day, or placebo. The primary end point was the placebo-corrected median percentage of change in TG from baseline to week 12. The baseline TG level was 680, 657, and 703 mg/dl for AMR101 4 g/day, AMR101 2 g/day, and placebo. AMR101 4 g/day reduced the placebo-corrected TG levels by 33.1% (n = 76, p 750 mg/dl, AMR101 4 g/day reduced the placebo-corrected TG levels by 45.4% (n = 28, p = 0.0001) and AMR101 2 g/day by 32.9% (n = 28, p = 0.0016). AMR101 did not significantly increase the placebo-corrected median LDL cholesterol levels at 4 g/day (-2.3%) or 2 g/day (+5.2%; both p = NS). AMR101 significantly reduced non-high-density lipoprotein cholesterol, apolipoprotein B, lipoprotein-associated phospholipase A(2), very low-density lipoprotein cholesterol, and total cholesterol. AMR101 was generally well tolerated, with a safety profile similar to that of the placebo. In conclusion, the present randomized, double-blind trial of patients with very high TG levels demonstrated that AMR101 significantly reduced the TG levels and improved other lipid parameters without significantly increasing the LDL cholesterol levels.
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