Evidence map›Paper›PMID 25066560›Full record

ArticleAmerican heart journal2014

Evaluating cardiovascular event reduction with ezetimibe as an adjunct to simvastatin in 18,144 patients after acute coronary syndromes: final baseline characteristics of the IMPROVE-IT study population.

Michael A Blazing, Robert P Giugliano, Christopher P Cannon, Thomas A Musliner, Andrew M Tershakovec, Jennifer A White, Craig Reist, Amy McCagg, Eugene Braunwald, Robert M Califf

2 registry-linked trialsOpen access · hybridAbstract read
PubMed Publisher
In one paragraph

Article in American heart journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00202878. Cited by 36 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 6 pooled it
21.4field-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.

NCT00202878 phase3completed

A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)

Ran2005Enrolled18,144Registered outcomes4Posted comparisons4ConditionsHypercholesterolemia, Myocardial InfarctionArmsezetimibe/simvastatin, Placebo for ezetimibe 10 mg/simvastatin 40 mg combination, Placebo for simvastatin 40 mg, simvastatin
PMID 26330412PMID 26039521PMID 20435175other papers from this trial
Open the trial in the graph
NCT04236817 nacompletednot on this mapstarted 2015, after this paper: background citation

Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY

TypeinterventionalSponsorThe Cleveland ClinicRan2015 to 2015Enrolled114ConditionsMedication Adherence, Medication ComplianceArmsPre-packed blisters for distribution of medications, Routine distribution of medications
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 6 syntheses or guidelines pooled it, 93 citations in OpenAlex.

  1. Pooled it
  2. Ezetimibe for the prevention of cardiovascular disease and all-cause mortality events.The Cochrane database of systematic reviews · 2018 · on this map
    Pooled it
  3. Ezetimibe-Statin Combination Therapy.Deutsches Arzteblatt international · 2016 · on this map
    Pooled it
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Benefit of Ezetimibe Added to Simvastatin in Reduced Kidney Function.Journal of the American Society of Nephrology : JASN · 2017
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Review
  15. Review
  16. Observational
  17. Article
  18. Review
  19. Article
  20. Current guidelines on prevention with a focus on dyslipidemias.Cardiovascular diagnosis and therapy · 2017
    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

10 authors at 3 institutions in 1 country.

Michael A BlazingDuke Clinical Research Institute, Durham, NC. Electronic address: michael.blazing@dm.duke.edu.
Robert P GiuglianoThrombolysis in Myocardial Infarction [TIMI] Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.
Christopher P CannonThrombolysis in Myocardial Infarction [TIMI] Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.
Thomas A MuslinerMerck & Co., Rahway, NJ.
Andrew M TershakovecMerck & Co., Rahway, NJ.
Jennifer A WhiteDuke Clinical Research Institute, Durham, NC.
Craig ReistDuke Clinical Research Institute, Durham, NC.
Amy McCaggThrombolysis in Myocardial Infarction [TIMI] Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.
Eugene BraunwaldThrombolysis in Myocardial Infarction [TIMI] Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.
Robert M CaliffDuke Clinical Research Institute, Durham, NC.
Brigham and Women's Hospital · USClinical Research Institute · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) is evaluating the potential benefit for reduction in major cardiovascular (CV) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) ≤ 125 mg/dL.

methodsThe primary composite end point is CV death, nonfatal myocardial infarction (MI), nonfatal stroke, rehospitalization for unstable angina (UA), and coronary revascularization (≥ 30 days postrandomization). The simvastatin monotherapy arm's LDL-C target is <70 mg/dL. Ezetimibe was assumed to further lower LDL-C by 15 mg/dL and produce an estimated ~8% to 9% treatment effect. The targeted number of events is 5,250.

resultsWe enrolled 18,144 patients with either ST-segment elevation MI (STEMI, n = 5,192) or UA/non-ST-segment elevation MI (UA/NSTEMI, n = 12,952) from October 2005 to July 2010. Western Europe (40%) and North America (38%) were the leading enrolling regions. The STEMI cohort was younger and had a higher percentage of patients naive to lipid-lowering treatment compared with the UA/NSTEMI cohort. The UA/NSTEMI group had a higher prevalence of diabetes, hypertension, and prior MI. Median LDL-C at entry was 100 mg/dL for STEMI and 93 mg/dL for UA/NSTEMI patients.

conclusionsThis trial is evaluating LDL-C lowering beyond previously targeted LDL-C levels. The results depend on achieving the desired separation of LDL-C with ezetimibe and on the assumption that ezetimibe's lowering of LDL-C will have similar event reduction efficacy as the LDL-C lowering from a statin. The results could affect future therapies and guidelines.

Indexed as

Acute Coronary SyndromeAgedAnticholesteremic AgentsAzetidinesCardiovascular DiseasesCholesterol, LDLDrug Therapy, CombinationEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedSimvastatinAnticholesteremic AgentsAzetidinesCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsSimvastatin

Identifiers

PMID25066560
OpenAlexW2151969933

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.