Evidence map›Paper›PMID 16369229›Full record

Trial reportMedGenMed : Medscape general medicine2005

LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD.

James McKenney, Christie M Ballantyne, Theodore A Feldman, William E Brady, Arvind Shah, Michael J Davies, Joanne Palmisano, Yale B Mitchel

2 registry-linked trialsOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in MedGenMed : Medscape general medicine, 2005. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 22% 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 15194017other papers from this trial
Open the trial in the graph
NCT00092716 phase3completednot on this map

A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

TypeinterventionalSponsorOrganon and CoRan2002 to 2003Enrolled655ConditionsHypercholesterolemiaArmsMK0653, ezetimibe / Duration of Treatment: 28 weeks, Comparator: atorvastatin / Duration of Treatment: 28 weeks
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Effect of Alirocumab Monotherapy vs Ezetimibe Plus Statin Therapy on LDL-C Lowering in Veterans With History of ASCVD.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2024
    Article
  4. Article
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 1 institution in 1 country.

James McKenneyNational Clinic Research, Inc., Richmond, Virginia, USA. jmckenney@ncrinc.net
Christie M Ballantyne
Theodore A Feldman
William E Brady
Arvind Shah
Michael J Davies
Joanne Palmisano
Yale B Mitchel
National Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the proportion of patients at high risk for coronary heart disease (CHD) achieving the recommended low-density lipoprotein cholesterol (LDL-C) treatment goal of < 100 mg/dL and the optional LDL-C target of < 70 mg/dL with coadministration of ezetimibe and simvastatin (EZE/SIMVA) vs either atorvastatin or simvastatin monotherapy. PATIENTS: Patients with established CHD or CHD risk equivalent according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria with baseline LDL-C = 130 mg/dL and triglycerides (TG) < or = 350 mg/dL.

methodsA post hoc analysis from 2 separate studies assessed the percentage of high-risk patients achieving the LDL-C targets (< 100 and < 70 mg/dL) after 6 weeks on the usual recommended starting doses of the following treatments: EZE/SIMVA (10/20 mg) vs atorvastatin (10 mg) or simvastatin (20 mg). Depending on the study, EZE/SIMVA 10/10 or 10/40 mg was also compared with either atorvastatin 10 mg or simvastatin 20 mg. Percent change in other lipid parameters from baseline to study endpoint was also examined.

resultsIn both studies, the proportions of patients achieving an LDL-C of < 100 mg/dL were significantly (P < .001) greater for EZE/SIMVA 10/10, 10/20, or 10/40 mg vs either atorvastatin 10 mg or simvastatin 20 mg after 6 weeks. The percentage reaching the optional LDL-C treatment target of < 70 mg/dL was also significantly higher with EZE/SIMVA compared with either atorvastatin or simvastatin. Percent reduction in LDL-C was significantly (P < .001) larger with all doses of EZE/SIMVA (46% to 59%) compared with either atorvastatin 10 mg (37%) or simvastatin 20 mg (38%) monotherapy after 6 weeks. Changes in other lipid parameters consistently favored EZE/SIMVA vs statin monotherapy. All treatments were well tolerated in both studies.

conclusionPatients at high risk for CHD are more likely to attain LDL-C treatment targets with the usual recommended starting dose of EZE/SIMVA (10 or 20 mg) therapy than with that of atorvastatin (10 mg) or simvastatin (20 mg) monotherapy.

Indexed as

AgedAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, LDLCoronary DiseaseDrug Therapy, CombinationEzetimibeFemaleHeptanoic AcidsHumansMaleMiddle AgedPyrrolesRisk FactorsSimvastatinAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, LDLEzetimibeHeptanoic AcidsPyrrolesSimvastatin

Identifiers

PMID16369229
PMCPMC1681670
OpenAlexW1482078817

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.