Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in
subjects with primary hypercholesterolemia.
Author(s): Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM,
Marshall JW.
Affiliation(s): Provident Clinical Research, Glen Ellyn, IL 60137, USA. KMaki@ProvidentCRC.com
Publication date & source: 2011, J Cardiovasc Pharmacol. , 57(4):489-94
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.
|