期刊
AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS
卷 13, 期 1, 页码 37-46出版社
ADIS INT LTD
DOI: 10.1007/s40256-012-0002-3
关键词
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资金
- Amarin Pharma Inc., Bedminster, NJ, USA
- Amarin Pharma Inc.
- Alere
- Amgen
- Ardea
- Arena
- AstraZeneca
- Boehringer Ingelheim
- California Raisin Board
- Cargill
- Eisai
- Esperion
- Essentialis
- Forest
- Gilead
- Given
- GlaxoSmithKline
- High Point Pharmaceuticals
- Hoffmann-LaRoche
- Home Access
- Johnson and Johnson
- Merck
- Micropharma
- Novartis
- NovoNordisk
- Omthera
- Orexigen
- Pfizer Inc
- Shionogi
- Stratum Nutrition
- Takeda
- TIMI
- Traanstech Pharma
- Trygg
- TWI Bio
- Vivus
- Xoma
- Abbott Laboratories
- Amarin Pharma, Inc.
- Bristol-Myers Squibb
- diaDexus
- Kowa Pharmaceuticals America, Inc.
- Merck Co.
- Roche
- Sanofi-Synthelabo
- National Institutes of Health
- American Diabetes Association
- American Heart Association
- Abbott
Background Icosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved by the US Food and Drug Administration as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>= 500 mg/dL) hypertriglyceridemia. In addition to TG-lowering effects, IPE also reduces non-high-density lipoprotein cholesterol and apolipoprotein B levels without significantly increasing low-density lipoprotein cholesterol (LDL-C) in patients with very high TO levels >= 500 mg/dL (MARINE study) and in patients with well-controlled LDL-C and residually high TO levels 200-500 mg/dL (ANCHOR study). This analysis examined the effect of IPE on inflammatory markers in patients from MARINE and ANCHOR. Methods MARINE (N = 229) and ANCHOR (N = 702) were Phase III, double-blind studies that randomized hypertriglyceridemic patients to IPE 4 g/day, 2 g/day, or placebo. This analysis assessed the median placebo-adjusted percentage change from baseline in markers representing various stages of atherosclerotic inflammation such as intercellular adhesion molecule-1 (ICAM-1), oxidized low-density lipoprotein (Ox-LDL), lipoprotein-associated phospholipase A(2) (Lp-PLA(2)), interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hsCRP). Results Compared to placebo, IPE 4 g/day significantly decreased Ox-LDL (13 %, p < 0.0001, ANCHOR), Lp-PLA(2) (14 %, p < 0.001, MARINE; 19 %, p < 0.0001, ANCHOR), and hsCRP levels (36 %, p < 0.01, MARINE; 22 %, p < 0.001, ANCHOR), but did not significantly change ICAM-1 and IL-6 levels. In the MARINE study, IPE 2 g/day did not significantly change ICAM-1, Ox-LDL, Lp-PLA(2), IL-6, or hsCRP levels. Also, compared to placebo in the ANCHOR study, IPE 2 g/day significantly decreased Lp-PLA(2) levels (8 %, p < 0.0001), but did not significantly change levels of other assessed inflammatory markers. Conclusion Compared to placebo, in hypertriglyceridemic patients, IPE 4 g/day significantly decreased Ox-LDL, Lp-PLA(2), and hsCRP levels.
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