Evidence map›Paper›PMID 15846260›Full record

ArticleAmerican heart journal2005

Comparison of ezetimibe plus simvastatin versus simvastatin monotherapy on atherosclerosis progression in familial hypercholesterolemia. Design and rationale of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial.

John J P Kastelein, Philip T Sager, Eric de Groot, Enrico Veltri

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in American heart journal, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00552097. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
13.2field-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.

NCT00552097 phase3completed

Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Subjects With Heterozygous Familial Hypercholesterolemia (The ENHANCE Trial)

Ran2002Enrolled720Registered outcomes5Posted comparisons0ConditionsAtherosclerosis, Hypercholesterolemia, Hyperlipoproteinemia Type IIArmsezetimibe (plus simvastatin), placebo (plus simvastatin)
Open the trial in the graph
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 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. Advances in targeting LDL cholesterol: PCSK9 inhibitors and beyond.American journal of preventive cardiology · 2024
    Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
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  12. Review
  13. Effective use of combination lipid therapy.Current atherosclerosis reports · 2006
    Article
  14. Effective use of combination lipid therapy.Current cardiology reports · 2005
    Review
  15. Article
  16. 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

4 authors at 1 institution in 1 country.

John J P KasteleinDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands. e.vandongen@amc.uva.nl
Philip T Sager
Eric de Groot
Enrico Veltri
Academic Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLipid lowering through statin therapy significantly reduces the risk of cardiovascular events. The ENHANCE study is an international 2-year, randomized, double-blind, controlled trial designed to test the hypothesis that treatment of hypercholesterolemia by use of 2 complementary agents, ezetimibe (a specific cholesterol absorption inhibitor) and simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor), will result in larger beneficial effects on carotid artery intima-media thickness (CA IMT) than simvastatin monotherapy.

methodsThe study will recruit 725 men and women with heterozygous familial hypercholesterolemia. After a placebo washout period, participants are randomized to receive daily administration of either simvastatin 80 mg and ezetimibe 10 mg or simvastatin 80 mg and placebo. The ENHANCE trial uses novel state-of-the-art single-frame digital image acquisition and rigorous quality assurance and control.

resultsThe primary end point is mean change from baseline to 2 years in CA IMT, using composite measures from the right and left far wall common carotid artery, carotid bulb, and internal carotid artery. Secondary end points include (1) the proportion of participants who exhibit reductions in CA IMT, (2) the change in maximum far wall IMT, (3) the proportion of participants who develop new carotid artery plaques, and (4) the changes in carotid plus common femoral artery IMT.

conclusionsThis study addresses the question of whether a regimen that uses drugs with different mechanisms of action will be of further benefit in terms of atherosclerosis reduction compared to statin monotherapy.

Indexed as

AdultAgedAnticholesteremic AgentsAzetidinesCarotid ArteriesDouble-Blind MethodDrug Therapy, CombinationEzetimibeFemaleHumansHyperlipoproteinemia Type IIMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignAnticholesteremic AgentsAzetidinesEzetimibeSimvastatin

Identifiers

PMID15846260
OpenAlexW1504536459

What OpenQuestion 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 OpenQuestion graph.