Evidence map›Paper›PMID 12719279›Full record

Trial reportCirculation2003

Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial.

Christie M Ballantyne, John Houri, Alberto Notarbartolo, Lorenzo Melani, Leslie J Lipka, Ramachandran Suresh, Steven Sun, Alexandre P LeBeaut, Philip T Sager, Enrico P Veltri and 1 more

2 registry-linked trialsAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 137 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 9 pooled it
65.3field-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.

NCT00988364 phase4completedstarted 2007, after this paper: background citation

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome

Ran2007Enrolled30Registered outcomes2Posted comparisons0ConditionsMetabolic SyndromeArmsEzetimibe, Placebo, simvastatin, Vytorin
PMID 15383192PMID 11375333PMID 12637336PMID 2459282PMID 1811552PMID 17030034PMID 15166790PMID 14757686PMID 12695302PMID 12689919PMID 11805008PMID 9144084other papers from this trial
Open the trial in the graph
NCT03867110 phase3completednot on this map

A Phase 3, Double-Blind Efficacy and Safety Study of Ezetimibe (SCH 58235) 10 mg in Addition to Atorvastatin Compared to Placebo in Subjects With Primary Hypercholesterolemia (Protocol P00692)

TypeinterventionalSponsorOrganon and CoRan2000 to 2001Enrolled628ConditionsHypercholesterolemiaArmsPlacebo, Ezetimibe 10 mg, Atorvastatin 10 mg, Atorvastatin 20 mg, Atorvastatin 40 mg
3 · Its place in the literature

Who cites it

137 citing papers in PubMed, 9 syntheses or guidelines pooled it, 676 citations in OpenAlex.

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  6. Prevalence of statin intolerance: a meta-analysis.European heart journal · 2022 · on this map
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77 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Christie M BallantyneBaylor College of Medicine, 6565 Fannin Street, MS A-601, Houston, Tex 77030, USA. cmb@bcm.tmc.edu
John Houri
Alberto Notarbartolo
Lorenzo Melani
Leslie J Lipka
Ramachandran Suresh
Steven Sun
Alexandre P LeBeaut
Philip T Sager
Enrico P Veltri
Ezetimibe Study Group
Baylor College of Medicine · USRadiant Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the established efficacy of statins, many patients do not achieve recommended LDL cholesterol (LDL-C) goals. Contributing factors may be inadequate dosing, increased risk for adverse effects with high-dose monotherapy, and increased potential for intolerance and adverse effects with combinations of available agents. METHODS AND

resultsIn a double-blind study, 628 patients with baseline LDL-C 145 to 250 mg/dL and triglycerides < or =350 mg/dL were randomly assigned to receive 1 of the following for 12 weeks: ezetimibe (10 mg/d); atorvastatin (10, 20, 40, or 80 mg/d); ezetimibe (10 mg) plus atorvastatin (10, 20, 40, or 80 mg/d); or placebo. The primary efficacy end point was percentage reduction in LDL-C for pooled ezetimibe plus atorvastatin versus pooled atorvastatin treatment groups. Ezetimibe plus atorvastatin significantly improved LDL-C, HDL cholesterol (HDL-C), triglycerides, total cholesterol:HDL-C, and high-sensitivity C-reactive protein (hs-CRP) compared with atorvastatin alone (P<0.01). Coadministration of ezetimibe provided a significant additional 12% LDL-C reduction, 3% HDL-C increase, 8% triglyceride reduction, and 10% hs-CRP reduction versus atorvastatin alone. Ezetimibe plus atorvastatin provided LDL-C reductions of 50% to 60%, triglyceride reductions of 30% to 40%, and HDL-C increases of 5% to 9%, depending on atorvastatin dose. LDL-C reductions with ezetimibe plus 10 mg atorvastatin (50%) and 80 mg atorvastatin alone (51%) were similar.

conclusionsEzetimibe plus atorvastatin was well tolerated, with a safety profile similar to atorvastatin alone and to placebo. When coadministered with atorvastatin, ezetimibe provided significant incremental reductions in LDL-C and triglycerides and increases in HDL-C. Coadministration of ezetimibe and atorvastatin offers a well-tolerated and highly efficacious new treatment option for patients with hypercholesterolemia.

Indexed as

Anticholesteremic AgentsAtorvastatinAzetidinesCholesterol, HDLCholesterol, LDLC-Reactive ProteinDigestive SystemDouble-Blind MethodDrug SynergismDrug Therapy, CombinationEzetimibeFemaleHeptanoic AcidsHumansHypercholesterolemiaMaleAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, HDLCholesterol, LDLC-Reactive ProteinEzetimibeHeptanoic AcidsPyrrolesTriglycerides

Identifiers

PMID12719279
OpenAlexW1987507883

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.