Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study)
Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN
The American journal of cardiology · 263 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
- Organización sin fines de lucro
- American Heart Association
Según 1 financiador declarado.
Publicación
- Publicado
- 2012-07-20 · Am J Cardiol · vol. 110 · número 7 · págs. 984–992
- Editorial
- Elsevier BV
- Citado
- 344 citas · más que el 100% de estudios similares · 22.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 16 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, statin-treated patients, non-HDL cholesterol, LDL cholesterol, apolipoprotein B, lipoprotein-associated phospholipase A2, high-sensitivity C-reactive protein, VLDL cholesterol, drug safety
- MeSH
- humans, cardiovascular diseases, hypertriglyceridemia, eicosapentaenoic acid, triglycerides, platelet aggregation inhibitors, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, retrospective studies, follow-up studies, double-blind method, time factors, middle aged, female, male
7 autores
- Christie Mitchell Ballantyne🇺🇸 · autor de correspondenciaBaylor College of Medicine
- Harold Edward Bays🇺🇸Louisville Metabolic and Atherosclerosis Research Center
- John J.P. Kastelein🇳🇱Amsterdam UMC Location University of Amsterdam
- Evan A. Stein🇺🇸Medpace (United States)
- 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 ω-3 fatty acid agent containing ≥96% pure icosapent-ethyl, the ethyl ester of eicosapentaenoic acid. The efficacy and safety of AMR101 were evaluated in this phase 3, multicenter, placebo-controlled, randomized, double-blinded, 12-week clinical trial (ANCHOR) in high-risk statin-treated patients with residually high triglyceride (TG) levels (≥200 and <500 mg/dl) despite low-density lipoprotein (LDL) cholesterol control (≥40 and <100 mg/dl). Patients (n = 702) on a stable diet were randomized to AMR101 4 or 2 g/day or placebo. The primary end point was median percent change in TG levels from baseline versus placebo at 12 weeks. AMR101 4 and 2 g/day significantly decreased TG levels by 21.5% (p <0.0001) and 10.1% (p = 0.0005), respectively, and non-high-density lipoprotein (non-HDL) cholesterol by 13.6% (p <0.0001) and 5.5% (p = 0.0054), respectively. AMR101 4 g/day produced greater TG and non-HDL cholesterol decreases in patients with higher-efficacy statin regimens and greater TG decreases in patients with higher baseline TG levels. AMR101 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and decreased apolipoprotein B (9.3%), total cholesterol (12.0%), very-low-density lipoprotein cholesterol (24.4%), lipoprotein-associated phospholipase A(2) (19.0%), and high-sensitivity C-reactive protein (22.0%) versus placebo (p <0.001 for all comparisons). AMR101 was generally well tolerated, with safety profiles similar to placebo. In conclusion, AMR101 4 g/day significantly decreased median placebo-adjusted TG, non-HDL cholesterol, LDL cholesterol, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, lipoprotein-associated phospholipase A(2), and high-sensitivity C-reactive protein in statin-treated patients with residual TG elevations.
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