Evidence map›Paper›PMID 17317370›Full record

Trial reportThe American journal of cardiology2007

Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study).

Christie M Ballantyne, Robert Weiss, Tiziano Moccetti, Anja Vogt, Bernd Eber, Froukje Sosef, Emma Duffield, EXPLORER Study Investigators

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of cardiology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04862962 (Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.), which is not on this map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
20.1field-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.

NCT04862962 completedstarted 2021, after this paper: background citation

Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.

Ran2021Enrolled120Registered outcomes5Posted comparisons0ConditionsDyslipidemiasArmsRosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Open the trial in the graph
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 196 citations in OpenAlex.

  1. Pooled it
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  4. Lipid-lowering efficacy of rosuvastatin.The Cochrane database of systematic reviews · 2014 · on this map
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  10. Differences in synthesis and absorption of cholesterol of two effective lipid-lowering therapies.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2012 · on this map
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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

8 authors at 6 institutions in 5 countries.

Christie M BallantyneMethodist DeBakey Heart Center, Baylor College of Medicine, Houston, Texas, USA. cmb@bcm.tmc.edu
Robert Weiss
Tiziano Moccetti
Anja Vogt
Bernd Eber
Froukje Sosef
Emma Duffield
EXPLORER Study Investigators
AstraZeneca (United Kingdom) · GBBarmherzige Schwestern vom heiligen Kreuz · ATBaylor College of Medicine · USCharité - Universitätsmedizin Berlin · DEEpatocentro Ticino · CHMaine Research Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients at risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) cholesterol goals on statin monotherapy. This study was designed to investigate the efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg in patients at high risk of coronary heart disease. Four hundred sixty-nine patients were randomly assigned to rosuvastatin alone or in combination with ezetimibe for 6 weeks. The primary end point was the percentage of patients achieving the Adult Treatment Panel III (ATP III) LDL cholesterol goal (<100 mg/dl) at week 6. Secondary end points included the percentage of patients achieving other ATP III and 2003 European lipid goals, changes from baseline in lipid, lipoprotein, and inflammatory parameters, and safety and tolerability. Significantly more patients receiving rosuvastatin/ezetimibe than rosuvastatin alone achieved their ATP III LDL cholesterol goal (<100 mg/dl, 94.0% vs 79.1%, p <0.001) and the optional LDL cholesterol goal (<70 mg/dl) for very high-risk patients (79.6% vs 35.0%, p <0.001). The combination of rosuvastatin/ezetimibe reduced LDL cholesterol significantly more than rosuvastatin (-69.8% vs -57.1%, p <0.001). Other components of the lipid/lipoprotein profile were also significantly (p <0.001) improved with rosuvastatin/ezetimibe. Both treatments generally were well tolerated. Rosuvastatin 40 mg was effective at improving the atherogenic lipid profile in this high-risk population. Combination rosuvastatin with ezetimibe 10 mg enabled greater decreases in LDL cholesterol and allowed more patients to achieve LDL cholesterol goals. In conclusion, rosuvastatin plus ezetimibe may improve the management of high-risk patients who cannot achieve goal on maximal statin monotherapy.

Indexed as

AgedAzetidinesCardiovascular DiseasesDose-Response Relationship, DrugDrug Therapy, CombinationEzetimibeFemaleFluorobenzenesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedPyrimidinesRosuvastatin CalciumSulfonamidesAzetidinesEzetimibeFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsPyrimidinesRosuvastatin CalciumSulfonamides

Identifiers

PMID17317370
OpenAlexW1985258577

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.