Document Detail


Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin.
MedLine Citation:
PMID:  20118387     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the effects of prescription omega-3-acid ethyl esters on non-high-density lipoprotein cholesterol (HDL-C) levels in atorvastatin-treated patients with elevated non-HDL-C and triglyceride levels. PATIENTS AND METHODS: This study, conducted between February 15, 2007, and October 22, 2007, randomized patients with elevated non-HDL-C (>160 mg/dL) and triglyceride (>or=250 mg/dL and <or=599 mg/dL) levels to double-blind treatment with prescription omega-3-acid ethyl esters, 4 g/d, or placebo for 16 weeks. Patients also received escalating dosages of open-label atorvastatin (weeks 0-8, 10 mg/d; weeks 9-12, 20 mg/d; weeks 13-16, 40 mg/d). RESULTS: Prescription omega-3-acid ethyl esters plus atorvastatin, 10, 20, and 40 mg/d, reduced median non-HDL-C levels by 40.2% vs 33.7% (P<.001), 46.9% vs 39.0% (P<.001), and 50.4% vs 46.3% (P<.001) compared with placebo plus the same doses of atorvastatin at the end of 8, 12, and 16 weeks, respectively. Prescription omega-3-acid ethyl esters plus atorvastatin also reduced median total cholesterol, triglyceride, and very low-density lipoprotein cholesterol levels and increased HDL-C levels to a significantly greater extent than placebo plus atorvastatin. Percent changes from baseline low-density lipoprotein-cholesterol, apolipoprotein A-I, and apolipoprotein B levels were not significantly different between groups at the end of the study. CONCLUSION: Prescription omega-3-acid ethyl esters plus atorvastatin produced significant improvements in non-HDL-C and other lipid parameters in patients with elevated non-HDL-C and triglyceride levels.
Authors:
Harold E Bays; James McKenney; Kevin C Maki; Ralph T Doyle; Roderick N Carter; Evan Stein
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Mayo Clinic proceedings. Mayo Clinic     Volume:  85     ISSN:  1942-5546     ISO Abbreviation:  Mayo Clin. Proc.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-02-25     Revised Date:  2010-09-28    
Medline Journal Info:
Nlm Unique ID:  0405543     Medline TA:  Mayo Clin Proc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  122-8     Citation Subset:  AIM; IM    
Affiliation:
Louisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Ave, Louisville, KY 40213, USA. hbaysmd@aol.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00435045
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MeSH Terms
Descriptor/Qualifier:
Analysis of Variance
Cholesterol, HDL / blood,  drug effects
Cholesterol, LDL / blood,  drug effects*
Docosahexaenoic Acids / administration & dosage*,  pharmacology
Dose-Response Relationship, Drug
Double-Blind Method
Drug Combinations
Drug Prescriptions
Drug Therapy, Combination
Eicosapentaenoic Acid / administration & dosage*,  pharmacology
Female
Heptanoic Acids / administration & dosage*,  pharmacology
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*,  pharmacology
Hypercholesterolemia / blood,  complications,  drug therapy*
Hypertriglyceridemia / blood,  complications,  drug therapy*
Male
Middle Aged
Pyrroles / administration & dosage*,  pharmacology
Treatment Outcome
United States
Chemical
Reg. No./Substance:
0/Cholesterol, HDL; 0/Cholesterol, LDL; 0/Drug Combinations; 0/Heptanoic Acids; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Omacor; 0/Pyrroles; 110862-48-1/atorvastatin; 1553-41-9/Eicosapentaenoic Acid; 25167-62-8/Docosahexaenoic Acids
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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