Evidence map›Paper›PMID 12713767›Full record

Trial reportEuropean heart journal2003

Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia.

R H Knopp, H Gitter, T Truitt, H Bays, C V Manion, L J Lipka, A P LeBeaut, R Suresh, B Yang, E P Veltri and 1 more

3 registry-linked trialsAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European heart journal, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 92 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing 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.

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.

NCT05613400 phase4unknown statusstarted 2022, after this paper: background citation

The Effect of Simvastatin on Bone Density in Postmenopausal Women With Type 2 Diabetes: a Double-blind, Randomized Active-comparator (Ezetimibe) Controlled Clinical Trial

Ran2022Enrolled240Registered outcomes7Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsEzetimibe 10mg, Simvastatin 10mg
Open the trial in the graph
NCT00466401 phase4completednot on this mapstarted 2005, after this paper: background citation

Phase 4 Study on Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation In Hypercholesterolemic Patients on Simvastatin

TypeinterventionalSponsorZiv HospitalRan2005 to 2007Enrolled20ConditionsHypercholesterolemiaArmsSimvastatin, Ezetimibe
NCT03975478 naunknown statusnot on this mapstarted 2019, after this paper: background citation

BASALTO (Bariatric Surgery and LDL Cholesterol) Trial

TypeinterventionalSponsorParc de Salut MarRan2019 to 2023Enrolled36ConditionsBariatric SurgeryArmsGastric bypass, Sleeve gastrectomy
3 · Its place in the literature

Who cites it

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

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  13. A Comprehensive, Updated Review of Ezetimibe: Evidence-Based Clinical Use for Atherosclerotic Cardiovascular Disease.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
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  15. Article
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  18. 2024 Egyptian consensus statement on the role of non-statin therapies for LDL cholesterol lowering in different patient risk categories.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2024
    Review
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32 more citing papers are in PubMed but not listed here.

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

11 authors.

R H KnoppDivision of Metabolism, Endocrinology & Nutrition, Northwest Lipid Research Clinic, 325 Ninth Avenue, Room 465, Box 359720, Seattle, WA 98104, USA. rhknopp@u.washington.edu
H Gitter
T Truitt
H Bays
C V Manion
L J Lipka
A P LeBeaut
R Suresh
B Yang
E P Veltri
Ezetimibe Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of ezetimibe 10 mg/day in patients with primary hypercholesterolemia. METHODS AND

resultsFollowing dietary stabilization, a 2-12-week washout period, and a 4-week, single-blind, placebo lead-in period, 827 patients with baseline low-density lipoprotein cholesterol (LDL-C) > or =3.36 mmol/l (130 mg/dl) to < or =6.47 mmol/l (250 mg/dl) and triglycerides < or =3.95 mmol/l (350 mg/dl) were randomized 3:1 to receive ezetimibe 10 mg or placebo orally once daily in the morning for 12 weeks. The primary efficacy endpoint was percentage reduction in direct plasma LDL-C. Ezetimibe reduced direct LDL-C by a mean of 17.7% from baseline to endpoint, compared with an increase of 0.8% with placebo (P<0.01). Response to ezetimibe was generally consistent across all subgroups analyzed. Ezetimibe also significantly improved levels of plasma total cholesterol, apolipoprotein B, high-density lipoprotein(2)-cholesterol and lipoprotein(a), and elicited a trend toward lower triglyceride levels. Ezetimibe did not alter the serum concentrations of lipid-soluble vitamins or significantly affect baseline or stimulated cortisol production. Ezetimibe was well tolerated, with a safety profile similar to that of placebo.

conclusionsEzetimibe, which significantly reduces LDL-C and favorably affects other lipid variables, may provide a well tolerated and effective new option for lipid management in the future.

Indexed as

AdultAgedAnticholesteremic AgentsAzetidinesCholesterol, LDLCosyntropinDouble-Blind MethodEzetimibeFemaleHumansHypercholesterolemiaMaleMiddle AgedSingle-Blind MethodTriglyceridesVitaminsAnticholesteremic AgentsAzetidinesCholesterol, LDLCosyntropinEzetimibeTriglyceridesVitamins

Identifiers

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.