title: Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester): Effects Upon High-Sensitivity C-Reactive Protein and Lipid Parameters in Patients With Metabolic Syndrome.
abstract: BACKGROUND
  The aim of this analysis was to examine the effects of icosapent ethyl (eicosapentaenoic acid ethyl ester, IPE) on high-sensitivity C-reactive protein (hsCRP) and lipid parameters in patients with metabolic syndrome, with and without stable statin therapy.
  
  
  METHODS
  This post hoc exploratory analysis evaluated patients with metabolic syndrome treated with IPE 4 grams/day, IPE 2 grams/day, or placebo in phase 3, randomized, placebo-controlled studies entitled: MARINE [triglyceride (TG) levels ≥500 and ≤2000 mg/dL] and ANCHOR [TG levels ≥200 and <500 mg/dL, despite low-density lipoprotein cholesterol (LDL-C) control with stable statin therapy].
  
  
  RESULTS
  Compared with placebo in patients with metabolic syndrome in MARINE (n=204) and ANCHOR (n=645), at the approved dose of 4 grams/day, IPE significantly lowered hsCRP levels 40.0% (P=0.0007) in MARINE and 23.0% (P=0.0003) in ANCHOR. Compared with placebo in MARINE, which included patients with and without statin therapy, IPE 4 grams/day significantly reduced hsCRP levels 78.0% in statin-treated patients (P=0.0035, n=16). Compared with placebo in MARINE, IPE 4 grams/day significantly reduced TG levels (35.0%; P<0.0001), non-high-density lipoprotein cholesterol (non-HDL-C; 19.9%; P<0.0001), and apolipoprotein B levels (ApoB) (9.1%; P=0.0015) without raising LDL-C levels. Compared with placebo in ANCHOR, IPE 4 grams/day significantly reduced TG (21.7%; P<0.0001), non-HDL-C (13.5%; P<0.0001), ApoB (8.8%; P<0.0001), LDL-C (5.2%; P=0.0236), and HDL-C levels (4.0%; P=0.0053).
  
  
  CONCLUSIONS
  Compared with placebo, IPE 4 grams/day significantly lowered hsCRP levels and improved lipids without raising LDL-C levels in patients with metabolic syndrome and high (≥200 and <500 mg/dL) or very high (≥500 and ≤2000 mg/dL) TG levels, with or without stable statin therapy.
authors.affiliation: 1 Louisville Metabolic and Atherosclerosis Research Center , Louisville, Kentucky.
authors.forename: Harold E
authors.initials: HE
authors.lastname: Bays
authors.affiliation: 2 Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center , Houston, Texas.
authors.forename: Christie M
authors.initials: CM
authors.lastname: Ballantyne
authors.affiliation: 3 Doylestown , Pennsylvania.
authors.forename: Rene A
authors.initials: RA
authors.lastname: Braeckman
authors.affiliation: 4 Amarin Pharma Inc. , Bedminster, New Jersey.
authors.forename: William G
authors.initials: WG
authors.lastname: Stirtan
authors.affiliation: 4 Amarin Pharma Inc. , Bedminster, New Jersey.
authors.forename: Ralph T
authors.initials: RT
authors.lastname: Doyle
authors.affiliation: 4 Amarin Pharma Inc. , Bedminster, New Jersey.|5 Chilton Medical Center , Pompton Plains, New Jersey.
authors.forename: Sephy
authors.initials: S
authors.lastname: Philip
authors.affiliation: 6 Mystic , Connecticut.
authors.forename: Paresh N
authors.initials: PN
authors.lastname: Soni
authors.affiliation: 4 Amarin Pharma Inc. , Bedminster, New Jersey.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Juliano
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015118:Eicosapentaenoic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018836:Inflammation Mediators / Q000097:blood*; D008055:Lipids / Q000097:blood*; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D018836:Inflammation Mediators; D008055:Lipids; C035276:eicosapentaenoic acid ethyl ester; D002097:C-Reactive Protein; D015118:Eicosapentaenoic Acid