title: Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials).
abstract: There are limited data on the efficacy and safety of triglyceride (TG)-lowering agents in women. We conducted subgroup analyses of the effects of icosapent ethyl (a high-purity prescription form of the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on TG levels (primary efficacy variable) and other atherogenic and inflammatory parameters in a total of 215 women with a broad range of TG levels (200-2000 mg/dl) enrolled in two 12-week placebo-controlled trials: MARINE (n = 18; placebo, n = 18) and ANCHOR (n = 91; placebo, n = 88). Icosapent ethyl 4 g/day significantly reduced TG levels from baseline to week 12 versus placebo in both MARINE (-22.7%; p = 0.0327) and ANCHOR (-21.5%; p <0.0001) without increasing low-density lipoprotein cholesterol levels. Significant improvements were also observed in non-high-density lipoprotein cholesterol levels in MARINE (-15.7%; p = 0.0082) and ANCHOR (-14.2%; p <0.0001) and total cholesterol levels in MARINE (-14.9%; p = 0.0023) and ANCHOR (-12.1%; p <0.0001), along with significant increases of >500% in eicosapentaenoic acid levels in plasma and red blood cells (all p <0.001). Icosapent ethyl was well tolerated, with adverse-event profiles comparable with findings in the overall studies. In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study.
authors.affiliation: Columbia University Medical Center, New York, New York. Electronic address: ljm10@columbia.edu.
authors.forename: Lori
authors.initials: L
authors.lastname: Mosca
authors.affiliation: Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Christie M
authors.initials: CM
authors.lastname: Ballantyne
authors.affiliation: Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky.
authors.forename: Harold E
authors.initials: HE
authors.lastname: Bays
authors.affiliation: Duke University School of Medicine, Durham, North Carolina.
authors.forename: John R
authors.initials: JR
authors.lastname: Guyton
authors.affiliation: Amarin Pharma Inc., Bedminster, New Jersey.
authors.forename: Sephy
authors.initials: S
authors.lastname: Philip
authors.affiliation: Amarin Pharma Inc., Bedminster, New Jersey.
authors.forename: Ralph T
authors.initials: RT
authors.lastname: Doyle
authors.affiliation: Amarin Pharma Inc., Bedminster, New Jersey.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Juliano
mesh_terms: D043203:1-Alkyl-2-acetylglycerophosphocholine Esterase / Q000097:blood; D000368:Aged; D053305:Apolipoprotein C-III / Q000097:blood; D001055:Apolipoproteins B / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D015243:Cholesterol, VLDL / Q000097:blood; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy*; D008077:Lipoproteins, LDL / Q000097:blood; D008079:Lipoproteins, VLDL / Q000097:blood; D008875:Middle Aged; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*
chemical_list: D053305:Apolipoprotein C-III; D001055:Apolipoproteins B; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D015243:Cholesterol, VLDL; D008077:Lipoproteins, LDL; D008079:Lipoproteins, VLDL; D014280:Triglycerides; C099252:oxidized low density lipoprotein; C030106:very low density lipoprotein triglyceride; C035276:eicosapentaenoic acid ethyl ester; D002097:C-Reactive Protein; D002784:Cholesterol; D015118:Eicosapentaenoic Acid; D043203:1-Alkyl-2-acetylglycerophosphocholine Esterase