Evidence map›Paper›PMID 26336957›Full record

Trial reportLipids in health and disease2015

Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk.

Jeffrey B Rosen, Christie M Ballantyne, Willa A Hsueh, Jianxin Lin, Arvind K Shah, Robert S Lowe, Andrew M Tershakovec

Registry-linked trialOpen access · goldFull text readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00409773. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT00409773 phase3completed

A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Ran2007Enrolled1,143Registered outcomes15Posted comparisons39ConditionsHypercholesterolemia, Metabolic SyndromeArmsComparator: atorvastatin calcium, Comparator: placebo (unspecified), ezetimibe (+) simvastatin
Open the trial in the graph
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. COSMIC project: consensus on the objectives of the metabolic syndrome in clinic.Diabetes, metabolic syndrome and obesity : targets and therapy · 2018
    Review
  4. Effect of Low Dose Atorvastatin Therapy on Baroreflex Sensitivity in Hypertensives.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2016
    Article
  5. 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

7 authors at 4 institutions in 1 country.

Jeffrey B RosenClinical Research of South Florida, Coral Gables, FL, USA. jrosen@crsouthflorida.com.
Christie M BallantyneBaylor College of Medicine and Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. cmb@bcm.tmc.edu.
Willa A HsuehWexner Medical Center, The Ohio State University, Columbus, Ohio, USA. willa.hsueh@osumc.edu.
Jianxin LinMerck & Co., Inc., Kenilworth, NJ, USA. jianxin_lin@merck.com.
Arvind K ShahMerck & Co., Inc., Kenilworth, NJ, USA. arvind_shah@merck.com.
Robert S LoweMerck & Co., Inc., Kenilworth, NJ, USA. lowero12@verizon.net.
Andrew M TershakovecMerck & Co., Inc., Kenilworth, NJ, USA. andrew_tershakovec@merck.com.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBaylor College of Medicine · USClinical Research of South Florida · USThe Ohio State University Wexner Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetabolic syndrome (MetS) and insulin resistance (IR) are increasing in prevalence, are associated with higher risk for coronary heart disease (CHD), and may potentially influence the responses to lipid-altering drug therapy. This study evaluated the effects of MetS factors (abdominal obesity, depleted high-density lipoprotein cholesterol [HDL-C], and elevated triglycerides, blood pressure, and fasting glucose) and IR on ezetimibe/simvastatin and atorvastatin treatment efficacy in patients with MetS.

methodsThis post-hoc analysis of a multicenter, 6-week, double-blind, randomized, parallel group study of 1128 subjects with hypercholesterolemia, MetS, and moderately high/high CHD risk evaluated the effects of baseline MetS factors/IR on percent change from baseline in lipids, apolipoproteins, and high-sensitivity C-reactive protein (hs-CRP), after treatment with the usual starting doses of ezetimibe/simvastatin (10/20 mg) versus atorvastatin (10 mg, 20 mg) and next higher doses (10/40 mg versus 40 mg).

resultsEzetimibe/simvastatin and atorvastatin efficacy was generally consistent across MetS factor/IR subgroups. Ezetimibe/simvastatin produced greater incremental percent reductions in LDL-C, non-HDL-C, apolipoprotein B, total cholesterol, and lipoprotein ratios for all subgroups, and larger percent increases in HDL-C and apolipoprotein AI for all but non-obese and HDL-C ≥ 40 mg/dL subgroups than atorvastatin at the doses compared. Triglycerides, very-LDL-C, and hs-CRP results were more variable but similar between treatment groups.

conclusionThe magnitude of lipid-altering effects produced by each treatment regimen was generally similar across all MetS and IR subgroups. Ezetimibe/simvastatin produced greater percent reductions in most lipid fractions than atorvastatin at the dose comparisons studied, and all treatments were generally well tolerated. (Registered at clinicaltrials.gov: NCT00409773).

Indexed as

AgedAnticholesteremic AgentsAtorvastatinBlood GlucoseBlood PressureCholesterol, LDLCoronary Artery DiseaseCoronary DiseaseC-Reactive ProteinDouble-Blind MethodEzetimibeFemaleHumansHypercholesterolemiaInsulin ResistanceLipoproteins, HDLAnticholesteremic AgentsAtorvastatinBlood GlucoseCholesterol, LDLC-Reactive ProteinEzetimibeLipoproteins, HDLSimvastatinTriglycerides

Identifiers

PMID26336957
PMCPMC4559874
OpenAlexW2170635270

What OpenQuestion holds

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LicenceCC BY
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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.