Evidence mapPaperPMID 20118387Full record

Trial reportMayo Clinic proceedings2010

Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin.

Harold E Bays, James McKenney, Kevin C Maki, Ralph T Doyle, Roderick N Carter, Evan Stein

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Mayo Clinic proceedings, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00435045 (A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
9.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00435045 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2007Enrolled245ConditionsHypertriglyceridemiaArmsLovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin, atorvastatin
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
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  8. Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2013
    Trial
  9. Review
  10. Dietary and Pharmacological Fatty Acids and Cardiovascular Health.The Journal of clinical endocrinology and metabolism · 2020
    Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Fish oil increases atherosclerosis and hepatic steatosis, although decreases serum cholesterol in Wistar rat.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2011
    Article
  18. Article
  19. Omega-3 Fatty acids for cardiovascular disease prevention.Current treatment options in cardiovascular medicine · 2010
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Ave, Louisville, KY 40213, USA. hbaysmd@aol.com
James McKenney
Kevin C Maki
Ralph T Doyle
Roderick N Carter
Evan Stein
Louisville Metabolic and Atherosclerosis Research Center · USReliant Technologies (United States) · USMB Clinical Research and Consulting (United States) · USNational Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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

methodsThis 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).

resultsPrescription 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.

conclusionPrescription 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.

Indexed as

Analysis of VarianceAtorvastatinCholesterol, HDLCholesterol, LDLDocosahexaenoic AcidsDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsDrug PrescriptionsDrug Therapy, CombinationEicosapentaenoic AcidFemaleHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaAtorvastatinCholesterol, HDLCholesterol, LDLDocosahexaenoic AcidsDrug CombinationsEicosapentaenoic AcidHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsOmacorPyrroles

Identifiers

PMID20118387
PMCPMC2813819
OpenAlexW2132263678

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.