Trial reportThe American journal of cardiology2008

Effects of adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia.

Kevin C Maki, James M McKenney, Matthew S Reeves, Barry C Lubin, Mary R Dicklin

Erratum issued Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of cardiology, 2008. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it supports the treatment in 1. An erratum has been issued. It reports registered trial NCT00487591. Cited by 23 papers, 2 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
23citing papers in PubMed, 2 pooled it
11.7field-weighted citation impact, top 1% 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.

← favours the treatmentfavours the comparator →
-5.000 · no effect
Diastolic blood pressureP-OM3 + simvastatin vs placebo + simvastatinfavours the treatment · dyslipidemiafeeds one cell of the map
Δ -3.30p <0.05
Favorable changes for P-OM3 + simvastatin versus placebo + simvastatin were also observed for very low-density lipoprotein (VLDL) cholesterol (-42% vs -22%), triglyceride (-44% vs -29%), total cholesterol (-31% vs -26%), HDL cholesterol (+16% vs +11%), apolipoprotein B (-32% vs -28%), total cholesterol:HDL cholesterol ratio (-39% vs -33%), triglyceride:HDL cholesterol ratio (-51% vs -37%), and systolic (-5.0 vs 0.3 mm Hg) and diastolic (-3.3 vs -1.8 mm Hg) blood pressures (p <0.05 for all).
Systolic blood pressureP-OM3 + simvastatin vs placebo + simvastatinfavours the treatment · dyslipidemiafeeds one cell of the map
Δ -5.00p <0.05
Favorable changes for P-OM3 + simvastatin versus placebo + simvastatin were also observed for very low-density lipoprotein (VLDL) cholesterol (-42% vs -22%), triglyceride (-44% vs -29%), total cholesterol (-31% vs -26%), HDL cholesterol (+16% vs +11%), apolipoprotein B (-32% vs -28%), total cholesterol:HDL cholesterol ratio (-39% vs -33%), triglyceride:HDL cholesterol ratio (-51% vs -37%), and systolic (-5.0 vs 0.3 mm Hg) and diastolic (-3.3 vs -1.8 mm Hg) blood pressures (p <0.05 for all).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×blood pressure

SupportsOpen on the map →What to test next →

9 readable studies in this cell: 4 favour the treatment, 4 find no difference, 1 favour the comparator.

Belief with this paper
0.83replicated · 5 families support, 1 contradict · against placebo
Without it
0.80This paper moves it by +0.03.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2008
Δ -3.30
4 · 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.

NCT00487591 completed

An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Ran2006Enrolled40Registered outcomes2Posted comparisons0ConditionsMixed DyslipidemiaArmsOmacor (omega-3-acid ethyl esters)plus simvastatin, simvastatin plus placebo
Open the trial in the graph
5 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Dietary and Pharmacological Fatty Acids and Cardiovascular Health.The Journal of clinical endocrinology and metabolism · 2020
    Review
  12. Review
  13. Observational
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
6 · The record

Corrections and comments

  • Erratum issued
7 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Kevin C MakiProvident Clinical Research, Glen Ellyn, Illinois, USA. KMAKI@ProvidentCRC.com
James M McKenney
Matthew S Reeves
Barry C Lubin
Mary R Dicklin
MB Clinical Research and Consulting (United States) · USNational Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

Prescription omega-3 acid ethyl esters (P-OM3) are commonly used for treatment of very high triglyceride levels, often in combination with a statin, to lower persistent hypertriglyceridemia. This randomized, crossover trial evaluated 6 weeks of combination therapy with simvastatin 20 mg/day plus P-OM3 4 g/day or placebo in 39 men and women (average age 58 years) with a triglyceride concentration 200 to 600 mg/dl and non-high-density lipoprotein (non-HDL) cholesterol greater than their National Cholesterol Education Program treatment goals after a 5-week diet lead-in. Non-HDL cholesterol decreased from baseline (209 mg/dl) by 40% for P-OM3 + simvastatin compared with 34% for placebo + simvastatin (p <0.001). Favorable changes for P-OM3 + simvastatin versus placebo + simvastatin were also observed for very low-density lipoprotein (VLDL) cholesterol (-42% vs -22%), triglyceride (-44% vs -29%), total cholesterol (-31% vs -26%), HDL cholesterol (+16% vs +11%), apolipoprotein B (-32% vs -28%), total cholesterol:HDL cholesterol ratio (-39% vs -33%), triglyceride:HDL cholesterol ratio (-51% vs -37%), and systolic (-5.0 vs 0.3 mm Hg) and diastolic (-3.3 vs -1.8 mm Hg) blood pressures (p <0.05 for all). VLDL particle concentration and size decreased and LDL particle size increased significantly more with P-OM3 + simvastatin than with placebo + simvastatin (all p <0.05). Changes in LDL cholesterol, LDL particle concentration, HDL particle size and concentration, and apolipoprotein A-I did not differ significantly between treatments. In conclusion, P-OM3 + simvastatin appears to be a useful therapeutic option for the management of mixed dyslipidemia.

Indexed as

AdolescentAdultAgedAnticholesteremic AgentsCholesterol, HDLCholesterol, VLDLCross-Over StudiesDrug Therapy, CombinationDyslipidemiasFatty Acids, Omega-3FemaleHumansHypertriglyceridemiaLipoproteinsMaleMiddle AgedAnticholesteremic AgentsCholesterol, HDLCholesterol, VLDLFatty Acids, Omega-3LipoproteinsSimvastatinTriglycerides

Identifiers

PMID18678300
OpenAlexW2142284567

What Socratic holds

Texttitle and abstract
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.