Effects of Prescription Omega-3-Acid Ethyl Esters on Non—High-Density Lipoprotein Cholesterol When Coadministered With Escalating Doses of Atorvastatin
Open accessAbstract
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.
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Doses of less than 2 g/d EPA+DHA are not effective for reducing triglycerides compared with higher doses, even in people with hypertriglyceridemia.
“Clinical research has further established that doses of <2 g/d EPA+DHA are not effective for reducing triglycerides compared with higher doses, even in people with HTG.33”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
The Other Lipid and Lipoprotein Parameters section (page unavailable) reports that 4 g/d prescription omega-3-acid ethyl esters significantly reduced triglycerides in patients with elevated triglycerides. The study compared that dose with placebo, not with doses below 2 g/d, so it does not establish that lower doses are ineffective. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn two of those O3AEE studies, apo B was reduced by 2% to 3%.
“and in 2 of these investigations, apo B was also reduced by 2% to 3%.22,33”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
Non-HDL-C decreased by 5% to 7% in the three largest studies of 4 g/d O3AEE.
“Non-HDL-C decreased by 5% to 7% in the 3 largest studies of 4 g/d O3AEE, 22,33,34”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
Only 3 of the trials presented in Table 4 specified that results were based on 2 independent measurements separated by at least 1 day.
“Only 3 of the trials presented in Table 4 specified that results were based on 2 independent measurements separated by at least 1 day.32,33,39”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
Six published monotherapy trials of 3 to 4 g/day n-3 fatty acids in patients with hypertriglyceridemia who were not taking other lipid-lowering medications met the inclusion criteria.
“Six published trials in which 3 to 4 g/d n-3 FA was administered to people with HTG not taking other lipidlowering medications were identified as meeting the inclusion criteria listed above.”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
The Patients and Methods section describes eligibility for this paper’s own trial, and its treatment-flow figure shows omega-3 fatty acids given with atorvastatin. Our copy does not report identifying six published monotherapy trials that met inclusion criteria; searches for that wording and for six omega-3 monotherapy trials found no such passage. Page numbers were not available in the indexed passages. (LLM, conf=0.75)
Experimental — accuracy not yet measured
Only 2 trials presented in Table 4 specified avoiding alcohol for at least 48 hours before testing.
“Only 2 trials presented in Table 4 specified avoiding alcohol for at least 48 hours before testing.29,33”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [33]
The Patients and Methods section describes eligibility and exclusions, and the End Points passage describes fasting measurements, but neither specifies avoiding alcohol before testing. Searches for alcohol and a 48-hour restriction found no such instruction in our copy. This paper also cannot establish the citing document’s count of two trials in Table 4. (LLM, conf=0.75)
Experimental — accuracy not yet measured
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- Authors
- Bays, H. E., McKenney, J., Maki, K. C., Doyle, R. T., Carter, R. N., & Stein, E.
- Affiliations
- Louisville Metabolic and Atherosclerosis Research Center (US)
- National Clinical Research (US)
- Corresponding author
- Bays, Harold E.
- Venue
- Mayo Clinic Proceedings
- Publisher
- Elsevier BV
- Published
- 2010-02
- Volume
- 85
- Issue
- 2
- Pages
- 122-128
- ISSN
- 0025-6196 (ISSN-L)
- PMC
- PMC2813819
- OpenAlex
- W2132263678
- Cited by
- 54
- References
- 27
- Citations by year
- 2023: 3 · 2022: 2 · 2021: 1 · 2020: 1 · 2019: 2 · 2018: 1 · 2016: 5 · 2015: 3 · 2014: 2 · 2013: 11 · 2012: 7
- FWCI
- 10.01
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Mayo Clinic Proceedings (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- GlaxoSmithKline (NCT00435045)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- omega-3 acid ethyl esters, atorvastatin, non-HDL cholesterol, triglycerides, hypertriglyceridemia, hypercholesterolemia, statin dose escalation, HDL cholesterol, VLDL cholesterol, apolipoprotein A-I, apolipoprotein B
- MeSH terms
- Atorvastatin, Analysis of Variance, Docosahexaenoic Acids, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Female, Heptanoic Acids, Humans, Hypercholesterolemia, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Drug Prescriptions, Pyrroles, United States, Eicosapentaenoic Acid, Hypertriglyceridemia, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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