Evidence map›Paper›PMID 19195513›Full record

Trial reportThe American journal of cardiology2009

Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia.

Anne C Goldberg, Harold E Bays, Christie M Ballantyne, Maureen T Kelly, Susan M Buttler, Carolyn M Setze, Darryl J Sleep, James C Stolzenbach

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of cardiology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01974297 (Comparison of the Efficacy and AtorVastatin 20mg mOnotherapy Versus Combination Atorvastatin/Fenofibric Acid 10/135mg in the Mixed hyperlipiDemia Who Were Not at Lipid gOals With Atorvastatin 10mg Monotherapy.), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
12.6field-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.

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.

NCT01974297 naunknown statusstarted 2013, after this paper: background citation

Comparison of the Efficacy and AtorVastatin 20mg mOnotherapy Versus Combination Atorvastatin/Fenofibric Acid 10/135mg in the Mixed hyperlipiDemia Who Were Not at Lipid gOals With Atorvastatin 10mg Monotherapy.

Ran2013Enrolled194Registered outcomes7Posted comparisons0ConditionsMixed HyperlipidemiaArmsAtorvastatin 10mg, fenofibric acid 135mg, atorvastatin 20mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Lipid-lowering efficacy of atorvastatin.The Cochrane database of systematic reviews · 2015 · on this map
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Fixed Combination for the Treatment of Dyslipidaemia.Current atherosclerosis reports · 2023
    Review
  10. Prescription omega-3 fatty acid products: considerations for patients with diabetes mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

8 authors at 4 institutions in 1 country.

Anne C GoldbergDepartment of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA. agoldber@im.wustl.edu
Harold E Bays
Christie M Ballantyne
Maureen T Kelly
Susan M Buttler
Carolyn M Setze
Darryl J Sleep
James C Stolzenbach
Abbott Fund · USHouston Methodist · USLouisville Metabolic and Atherosclerosis Research Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In patients with mixed dyslipidemia characterized by increased triglycerides (TG), decreased high-density lipoprotein (HDL) cholesterol, and increased low-density lipoprotein (LDL) cholesterol, monotherapy with lipid-altering drugs often fails to achieve all lipid targets. This multicenter, double-blind, active-controlled study evaluated ABT-335 (fenofibric acid) in combination with 2 doses of atorvastatin in patients with mixed dyslipidemia. A total of 613 patients with LDL cholesterol > or =130 mg/dl, TG > or =150 mg/dl, and HDL cholesterol <40 mg/dl for men and <50 mg/dl for women were randomly assigned to ABT-335 (135 mg), atorvastatin (20, 40, or 80 mg), or combination therapy (ABT-335 + atorvastatin 20 or 40 mg) and treated for 12 weeks. Combination therapy with ABT-335 + atorvastatin 20 mg resulted in significantly greater improvements in TG (-45.6% vs -16.5%) and HDL cholesterol (14.0% vs 6.3%) compared with atorvastatin 20 mg and LDL cholesterol (-33.7% vs -3.4%) compared with ABT-335. Similarly, significantly greater improvements were observed with ABT-335 + atorvastatin 40 mg in TG (-42.1% vs -23.2%) and HDL cholesterol (12.6% vs 5.3%) compared with atorvastatin 40 mg and LDL cholesterol (-35.4% vs -3.4%) compared with ABT-335 monotherapy. Combination therapy also improved multiple secondary variables. Combination therapy was generally well tolerated with a safety profile consistent with those of ABT-335 and atorvastatin monotherapies. No rhabdomyolysis was reported. In conclusion, ABT-335 + atorvastatin combination therapy resulted in more effective control of multiple lipid parameters than either monotherapy and may be an appropriate therapy for patients with mixed dyslipidemia.

Indexed as

AdultAgedAnticholesteremic AgentsAtorvastatinCholesterol, HDLCholesterol, LDLDouble-Blind MethodDrug Therapy, CombinationDyslipidemiasFemaleFenofibrateHeptanoic AcidsHumansMaleMiddle AgedPyrrolesAnticholesteremic AgentsAtorvastatinCholesterol, HDLCholesterol, LDLFenofibratefenofibric acidHeptanoic AcidsPyrrolesTriglycerides

Identifiers

PMID19195513
OpenAlexW2077621811

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.