Evidence map›Paper›PMID 15194017›Full record

Trial reportThe American journal of cardiology2004

Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals.

Theodore Feldman, Michael Koren, William Insull, James McKenney, Helmut Schrott, Andrew Lewin, Sukrut Shah, Michelle Sidisin, Meehyung Cho, Debra Kush and 1 more

Registry-linked trialAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The American journal of cardiology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00551447. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
20.2field-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.

NCT00551447 phase3completed

A Comparison of Treatment With Ezetimibe (SCH 58235) and Simvastatin Coadministration Versus Simvastatin in Attaining the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Coronary Heart Disease (CHD) or CHD Risk Equivalent Strata Low-Density Lipoprotein Cholesterol (LDL-c)

Ran2002Enrolled616Registered outcomes2Posted comparisons0ConditionsCoronary DiseaseArmsComparator: simvastatin / Duration of Treatment: 27 Weeks, MK0653, ezetimibe / Duration of Treatment: 27 Weeks, MK0733, simvastatin / Duration of Treatment: 27 Weeks
PMID 16004682PMID 16369229other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 138 citations in OpenAlex.

  1. Ezetimibe-Statin Combination Therapy.Deutsches Arzteblatt international · 2016 · 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

11 authors at 6 institutions in 1 country.

Theodore FeldmanMiami Research Associates, Coral Gables, Florida 33146, USA. tfeldmanmd@aol.com
Michael Koren
William Insull
James McKenney
Helmut Schrott
Andrew Lewin
Sukrut Shah
Michelle Sidisin
Meehyung Cho
Debra Kush
Yale Mitchel
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBaylor College of Medicine · USJacksonville Center for Clinical Research · USNational Clinical Research · USNational Research Institute · USUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study assessed whether the co-administration of ezetimibe and simvastatin would be more effective than simvastatin monotherapy in allowing high-risk patients to achieve a low-density lipoprotein (LDL) cholesterol goal of <100 mg/dl. Men and women with LDL cholesterol >/=130 mg/dl and meeting National Cholesterol Education Program Adult Treatment Panel III criteria for coronary heart disease (CHD) or CHD risk equivalent were randomized to 1 of 4 daily treatments for 23 weeks: simvastatin 20 mg (n = 253), ezetimibe 10 mg plus simvastatin 10 mg (n = 251), ezetimibe 10 mg plus simvastatin 20 mg (n = 109), and ezetimibe 10 mg plus simvastatin 40 mg (n = 97). In all groups, patients not at goal had their simvastatin doses doubled at weeks 6, 12, and/or 18, up to a maximum of 80 mg. The primary efficacy objective was LDL cholesterol goal attainment (<100 mg/dl) after 5 weeks of treatment. Ezetimibe plus any dose of simvastatin produced greater reductions in LDL cholesterol and allowed more patients to achieve goal after 5 weeks (p <0.001) and at the end of the study (p <0.001) than simvastatin 20 mg alone. At 5 weeks, 75%, 83%, and 87% of patients receiving ezetimibe plus simvastatin 10, 20, and 40 mg had LDL cholesterol <100 mg/dl compared with 46% of patients receiving simvastatin 20 mg. In patients who started on ezetimibe plus simvastatin 10, 20 and 40 mg, 33%, 22%, and 12%, respectively, required simvastatin titration during the study compared with 68% of patients who started on simvastatin 20 mg. The corresponding median simvastatin doses used were 10, 20, 40, and 40 mg, respectively. Ezetimibe plus simvastatin was well tolerated, with an overall safety profile similar to that of simvastatin monotherapy. Thus, through the dual inhibition of cholesterol absorption and synthesis, ezetimibe plus simvastatin allowed more patients to reach LDL cholesterol <100 mg/dl at a lower simvastatin dose and with fewer dose titrations than simvastatin monotherapy.

Indexed as

AdultAgedAged, 80 and overAnticholesteremic AgentsAzetidinesCholesterol, LDLCoronary DiseaseDose-Response Relationship, DrugDrug Therapy, CombinationEzetimibeFemaleHumansHypercholesterolemiaMaleMiddle AgedPractice Guidelines as TopicAnticholesteremic AgentsAzetidinesCholesterol, LDLEzetimibeSimvastatin

Identifiers

PMID15194017
OpenAlexW2132211266

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.