Evidence map›Other lipid agents × lipids›PMID 19081418›Full record

Trial reportAmerican heart journal2009

Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study.

Syed M Mohiuddin, Carl J Pepine, Maureen T Kelly, Susan M Buttler, Carolyn M Setze, Darryl J Sleep, James C Stolzenbach

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in American heart journal, 2009. The graph read 6 numbers from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. 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 26 papers, 1 of them a synthesis that pooled it.

6numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Read, but not usablea number the graph found but could not read as for or against

HDL-C increasedABT-335 + simvastatin 40 vs simvastatin 40comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ 18.9
HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids
TGs decreasedABT-335 + simvastatin 20 vs simvastatin 20comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ -37.4
HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids
LDL-C decreasedABT-335 + simvastatin 20 vs ABT-335comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ -24.0
HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids
HDL-C increasedABT-335 + simvastatin 20 vs simvastatin 20comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ 17.8
HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids
TGs decreasedABT-335 + simvastatin 40 vs simvastatin 40comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ -42.7
HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids
LDL-C decreasedABT-335 + simvastatin 40 vs ABT-335comparator not stated · dyslipidemiafeeds 2 cells of the map
Δ -25.3
HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335).
FeedsStatins×lipidsOther lipid agents×lipids

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.

Other lipid agents×lipids

No readable resultOpen on the map →What to test next →

28 readable studies in this cell: 17 favour the treatment, 2 find no difference, 9 favour the comparator.

Belief with this paper
0.50contested · 15 families support, 6 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT004793881,216 enrolled · 2007
Δ -4.50-7.70 to -1.30
NCT00862251808 enrolled · 2009
Percent change in least-square means -14.8-19.6 to -9.91
NCT00485758796 enrolled · 2007
Δ -17.9-21.4 to -14.4
NCT00730132712 enrolled · 2008
Δ -5.75-9.43 to -2.07
NCT01763827615 enrolled · 2013
Δ -39.3-43.3 to -35.3
NCT01984424511 enrolled · 2013
Δ -37.8-42.3 to -33.3
Initial combination therapy with metformin plus colesevelam improves l…PMID 22836068 · 502 enrolled · 2007
change 8.30
NCT06005597407 enrolled · 2024
Least Squares (LS) Means -27.9-37.5 to -18.4
NCT03337308382 enrolled · 2017
Δ -38.0-46.5 to -29.6
NCT02227784366 enrolled · 2014
Δ -6.14-12.2 to -0.22
NCT01763905307 enrolled · 2013
Δ -38.1-43.7 to -33.0
NCT03001076269 enrolled · 2016
Δ -28.4-34.4 to -22.5

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Statins×lipids

No readable resultOpen on the map →What to test next →

38 readable studies in this cell: 27 favour the treatment, 5 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 21 families support, 7 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT002899002,340 enrolled · 2006
Δ -13.2-16.8 to -9.60
Effect of evolocumab or ezetimibe added to moderate- or high-intensity…PMID 24825642 · 2,067 enrolled · 2013
reduced -66.0-73.0 to -58.0
NCT02546323543 enrolled · 2015
Δ -35.5-40.2 to -30.7
NCT01678820299 enrolled · 2012
Δ 0.50-4.80 to 5.80
NCT01218204287 enrolled · 2010
Δ 5.47-15.7 to 26.7
Lipid-Lowering Effect and Safety of Ezetimibe and Atorvastatin 5 mg in…PMID 40357888 · 252 enrolled · 2022
Δ -47.6
NCT0093525931 enrolled · 2009
Δ -51.7
Effect of Patient Financial Incentives on Statin Adherence and Lipid C…PMID 33034639 · 2020
reductions -33.6-38.8 to -28.4
Icosabutate, a Structurally Engineered Fatty Acid, Improves the Cardio…PMID 27160246 · 2016
Δ -7.40
Evidence for statin pleiotropy in humans: differential effects of stat…PMID 19075102 · 2009
RR 38.0
Efficacy and safety of fluvastatin in patients with non-insulin-depend…PMID 8198023 · 1994
decrease -24.3
Rosuvastatin in older patients with systolic heart failure.PMID 17984166 · 2007
Δ 45.0

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

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.

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
PMID 22592524PMID 18996523PMID 20816118PMID 20934572PMID 20110022PMID 18650989PMID 15247520PMID 17520105PMID 19195513other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Prescription omega-3 fatty acid products: considerations for patients with diabetes mellitus.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

7 authors.

Syed M MohiuddinThe Creighton Cardiac Center, Omaha, NE 68131, USA. smm@creighton.edu
Carl J Pepine
Maureen T Kelly
Susan M Buttler
Carolyn M Setze
Darryl J Sleep
James C Stolzenbach

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.

backgroundPatients with mixed dyslipidemia often require combination therapy to effectively control lipid abnormalities. This study compared the effects of combination therapy with ABT-335 (a new formulation of fenofibric acid) and simvastatin to ABT-335 and simvastatin monotherapies on lipid and nonlipid parameters in patients with mixed dyslipidemia.

methodsThis was a phase 3, multicenter, randomized, double-blind, active-controlled study. A total of 657 patients with mixed dyslipidemia (low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL, triglycerides [TGs] > or =150 mg/dL, and high-density lipoprotein cholesterol [HDL-C]<40 mg/dL [men] or <50 mg/dL [women]) were randomized to 12 weeks of treatment with ABT-335 + simvastatin (20 or 40 mg) combination therapy, ABT-335 monotherapy (135 mg), or simvastatin monotherapy (20, 40, or 80 mg).

resultsCombination therapy resulted in significantly greater increases in HDL-C and decreases in TGs compared to the corresponding simvastatin monotherapy dose (P < .001) and decreases in LDL-C compared to ABT-335 monotherapy (P < .001). HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335). HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335). Twelve-week treatment with combination therapy was generally well tolerated with a safety profile consistent with ABT-335 and simvastatin monotherapies. No cases of rhabdomyolysis were reported.

conclusionFor patients with mixed dyslipidemia, combination therapy provided more effective control of multiple lipid parameters than either monotherapy alone, with a safety profile similar to both monotherapies.

Indexed as

AdultAgedAged, 80 and overDouble-Blind MethodDrug Therapy, CombinationDyslipidemiasFemaleFenofibrateHumansHypolipidemic AgentsMaleMiddle AgedSimvastatinYoung Adult2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidFenofibratefenofibric acidHypolipidemic AgentsSimvastatin

Identifiers

PMID19081418

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.