Evidence map›Paper›PMID 26486166›Full record

Trial reportJournal of the American Heart Association2015

Effect of Switching From Statin Monotherapy to Ezetimibe/Simvastatin Combination Therapy Compared With Other Intensified Lipid-Lowering Strategies on Lipoprotein Subclasses in Diabetic Patients With Symptomatic Cardiovascular Disease.

Ngoc-Anh Le, Joanne E Tomassini, Andrew M Tershakovec, David R Neff, Peter W F Wilson

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00862251. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 6% 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.

NCT00862251 phase3completed

A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switching to Rosuvastatin or Doubling the Statin Dose

Ran2009Enrolled808Registered outcomes18Posted comparisons30ConditionsCardiovascular Disorder, Diabetes MellitusArmsatorvastatin 10 mg or simvastatin 20 mg, ezetimibe (+) simvastatin, Rosuvastatin, simvastatin 40 mg or atorvastatin 20 mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  3. Pooled it
  4. Ezetimibe for the prevention of cardiovascular disease and all-cause mortality events.The Cochrane database of systematic reviews · 2018 · on this map
    Pooled it
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
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

5 authors at 2 institutions in 1 country.

Ngoc-Anh LeBiomarker Core Laboratory, Atlanta VAMC, Decatur, GA (N.A.L., P.F.W.).
Joanne E TomassiniMerck Research Laboratories, Kenilworth, NJ (J.E.T., A.M.T., D.R.N.).
Andrew M TershakovecMerck Research Laboratories, Kenilworth, NJ (J.E.T., A.M.T., D.R.N.).
David R NeffMerck Research Laboratories, Kenilworth, NJ (J.E.T., A.M.T., D.R.N.).
Peter W F WilsonBiomarker Core Laboratory, Atlanta VAMC, Decatur, GA (N.A.L., P.F.W.) Emory University School of Medicine, Atlanta, GA (P.F.W.).
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAtlanta VA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with diabetes mellitus and cardiovascular disease may not achieve adequate low-density lipoprotein cholesterol (LDL-C) lowering on statin monotherapy, attributed partly to atherogenic dyslipidemia. More intensive LDL-C-lowering therapy can be considered for these patients. A previous randomized, controlled study demonstrated greater LDL-C lowering in diabetic patients with symptomatic cardiovascular disease who switched from simvastatin 20 mg (S20) or atorvastatin 10 mg (A10) to combination ezetimibe/simvastatin 10/20 mg (ES10/20) therapy, compared with statin dose-doubling (to S40 or A20) or switching to rosuvastatin 10 mg (R10). The effect of these regimens on novel biomarkers of atherogenic dyslipidemia (low- and high-density lipoprotein particle number and lipoprotein-associated phospholipase A2 [Lp-PLA2]) was assessed. METHODS AND

resultsTreatment effects on low- and high-density lipoprotein particle number (by NMR) and Lp-PLA2 (by ELISA) were evaluated using plasma samples available from 358 subjects in the study. Switching to ES10/20 reduced low-density lipoprotein-particle number numerically more than did statin dose-doubling and was comparable with R10 (-133.3, -94.4, and -56.3 nmol/L, respectively; P>0.05). Increases in high-density lipoprotein particle number were significantly greater with switches to ES10/20 versus statin dose-doubling (1.5 and -0.5 μmol/L; P<0.05) and comparable with R10 (0.7 μmol/L; P>0.05). Percentages of patients attaining low-density lipoprotein particle number levels <990 nmol/L were 62.4% for ES10/20, 54.1% for statin dose-doubling, and 57.0% for R10. Switching to ES10/20 reduced Lp-PLA2 activity significantly more than did statin dose-doubling (-28.0 versus -3.8 nmol/min per mL, P<0.05) and was comparable with R10 (-28.0 versus -18.6 nmol/min per mL; P>0.05); effects on Lp-PLA2 concentration were modest.

conclusionsIn diabetic patients with dyslipidemia, switching from statins to combination ES10/20 therapy generally improved lipoprotein subclass profile and Lp-PLA2 activity more than did statin dose-doubling and was comparable with R10, consistent with its lipid effects. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00862251.

Indexed as

Drug Substitution1-Alkyl-2-acetylglycerophosphocholine EsteraseAgedBiomarkersCardiovascular DiseasesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Double-Blind MethodDyslipidemiasEuropeEzetimibe, Simvastatin Drug CombinationFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteinsMale1-Alkyl-2-acetylglycerophosphocholine EsteraseBiomarkersEzetimibe, Simvastatin Drug CombinationHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteinsPLA2G7 protein, humandiabetes mellitusezetimibelipoprotein‐associated phospholipase A2lipoprotein particle numberlipoprotein subclassesNMR spectroscopyrosuvastatinsimvastatin

Identifiers

PMID26486166
PMCPMC4845107
OpenAlexW2175217182

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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.