Evidence mapPaperPMID 18765432Full record

ArticleThe New England journal of medicine2008

Analyses of cancer data from three ezetimibe trials.

Richard Peto, Jonathan Emberson, Martin Landray, Colin Baigent, Rory Collins, Robert Clare, Robert Califf

3 registry-linked trialsOpen access · bronzeAbstract readCommentComparative Study
PubMed Publisher
In one paragraph

Article in The New England journal of medicine, 2008. 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 66 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 7 pooled it
14.0field-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
Open the trial in the graph
NCT00092677 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Ezetimibe + Simvastatin on Clinical Outcomes in Patients With Aortic Stenosis

TypeinterventionalSponsorOrganon and CoRan2001 to 2008Enrolled1,873ConditionsAortic StenosisArmsezetimibe (+) simvastatin, Comparator: Placebo
NCT00125593 phase4completednot on this map

Study of Heart and Renal Protection (SHARP): The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease: a Randomized Placebo-controlled Trial

TypeinterventionalSponsorUniversity of OxfordRan2003 to 2010Enrolled9,438ConditionsKidney Disease, ChronicArmsSimvastatin 20 mg, Ezetimibe 10mg, Placebo
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 7 syntheses or guidelines pooled it, 230 citations in OpenAlex.

  1. Pooled it
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  6. Potential increased risk of cancer from commonly used medications: an umbrella review of meta-analyses.Annals of oncology : official journal of the European Society for Medical Oncology · 2014
    Pooled it
  7. Pooled it
  8. The Effect of Atorvastatin on Breast Cancer Biomarkers in High-Risk Women.Cancer prevention research (Philadelphia, Pa.) · 2016
    Trial
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  13. Article
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  17. Ezetimibe and Cancer: Is There a Connection?Frontiers in pharmacology · 2022
    Review
  18. Article
  19. Review
  20. Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Richard PetoClinical Trial Service Unit & Epidemiological Studies Unit, Oxford University, Oxford, United Kingdom.
Jonathan Emberson
Martin Landray
Colin Baigent
Rory Collins
Robert Clare
Robert Califf
University of Oxford · GBClinical Research Institute · USDuke University · US

Funding

Medical Research Council MC_U137686853
6 · The paper itself

Abstract

backgroundFive years of statin therapy lowers low-density lipoprotein (LDL) cholesterol substantially and, over a 5-year period, results in reductions in the incidence of cardiovascular events. The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial (ClinicalTrials.gov number, NCT00092677) has raised the hypothesis that adding ezetimibe to statin therapy for larger LDL cholesterol reductions might increase the incidence of cancer.

methodsWe compared the results of a hypothesis-generating analysis of the incidence of cancer in the SEAS trial of ezetimibe plus simvastatin in 1873 patients (mean follow-up after ezetimibe or matching placebo was begun, 4.1 years) with a hypothesis-testing analysis of cancer data from the two large ongoing trials of this regimen: the Study of Heart and Renal Protection (SHARP) (NCT00125593) with 9264 patients (mean follow-up, 2.7 years) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) (NCT00202878), currently with 11,353 patients (mean follow-up, 1.0 year).

resultsIn the SEAS trial, assignment to ezetimibe was associated with an increase in any new onset of cancer (101 patients in the active-treatment group vs. 65 in the control group) from several cancer sites. In SHARP and IMPROVE-IT combined, there was no overall excess of cancer (313 active-treatment vs. 326 control; risk ratio, 0.96; 95% confidence interval, 0.82 to 1.12; P=0.61) and no significant excess at any particular site. Among patients assigned to ezetimibe, there were more, albeit not significantly more, deaths from cancer (97, vs. 72 in the control group; P=0.07), but there were also fewer, although not significantly fewer, other cases of cancer (216, vs. 254 in the control group; P=0.08). There was no evidence of a trend in the risk ratio for incidence of or death from cancer with increasing duration of follow-up.

conclusionsThe available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer. Follow-up of longer duration will permit the balance of risks and benefits to be determined more reliably.

Indexed as

Anticholesteremic AgentsAortic Valve StenosisAzetidinesCholesterol, LDLDrug Therapy, CombinationEzetimibeFollow-Up StudiesHumansHypercholesterolemiaIncidenceNeoplasmsRandomized Controlled Trials as TopicRiskSimvastatinAnticholesteremic AgentsAzetidinesCholesterol, LDLEzetimibeSimvastatin

Identifiers

PMID18765432
OpenAlexW2021879218

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.