title: Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia.
abstract: This double-blind, randomized crossover study investigated the effects of 6 weeks of treatment with prescription omega-3-acid ethyl esters (POM3, 4 g/day) versus placebo (soy oil) on low-density lipoprotein cholesterol (LDL-C) and other aspects of the fasting lipid profile in 31 men and women with primary, isolated hypercholesterolemia (LDL-C 130-220 mg/dL and triglycerides less than 150 mg/dL while free of lipid-altering therapies). Mean ± standard error of the mean baseline concentrations of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), very-low-density lipoprotein cholesterol, and triglycerides were 229 ± 3, 146 ± 3, 60 ± 2, 23 ± 2, and 113 ± 8 mg/dL, respectively. POM3 produced a modest increase from baseline in LDL-C (3.4%) versus the placebo response (-0.7%, P = 0.010). Significant changes (P < 0.05) for POM3 (placebo-corrected) were observed for very-low-density lipoprotein cholesterol (-18.8%), triglycerides (-18.7%), and HDL-C (3.3%). Nuclear magnetic resonance-determined very-low-density lipoprotein particle concentration and size and HDL particle concentration decreased significantly more with POM3 versus placebo, whereas LDL and HDL particle sizes increased significantly more with POM3 versus placebo. Total cholesterol, non-HDL-C, apolipoproteins A1 and B, and LDL particle concentration responses did not differ between treatments. These results did not confirm the hypothesis that POM3 treatment would lower LDL-C in primary, isolated hypercholesterolemia. Effects on other variables were consistent with prior results in mixed dyslipidemia.
authors.affiliation: Provident Clinical Research, Glen Ellyn, IL 60137, USA. KMaki@ProvidentCRC.com
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Maki
authors.forename: Andrea L
authors.initials: AL
authors.lastname: Lawless
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Kelley
authors.forename: Mary R
authors.initials: MR
authors.lastname: Dicklin
authors.forename: Valerie N
authors.initials: VN
authors.lastname: Kaden
authors.forename: Arianne L
authors.initials: AL
authors.lastname: Schild
authors.forename: Tia M
authors.initials: TM
authors.lastname: Rains
authors.forename: John W
authors.initials: JW
authors.lastname: Marshall
mesh_terms: D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D018592:Cross-Over Studies; D004281:Docosahexaenoic Acids; D004311:Double-Blind Method; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid; D005215:Fasting; D015525:Fatty Acids, Omega-3 / Q000494:pharmacology*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008055:Lipids / Q000097:blood*; D009682:Magnetic Resonance Spectroscopy; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000097:blood
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D008055:Lipids; D014280:Triglycerides; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor