Evidence map›Paper›PMID 21050476›Full record

Trial reportLipids in health and disease2010

Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency.

Margus Viigimaa, Helena Vaverkova, Michel Farnier, Maurizio Averna, Luc Missault, Mary E Hanson, Qian Dong, Arvind Shah, Philippe Brudi

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00479713 (A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT00479713 phase3completednot on this map

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

TypeinterventionalSponsorOrganon and CoRan2007 to 2008Enrolled618ConditionsHypercholesterolemiaArmsezetimibe (+) simvastatin, Comparator : rosuvastatin calcium, Comparator: Placebo (unspecified)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

9 authors at 5 institutions in 5 countries.

Margus ViigimaaTallinn University of Technology, Technomedicum, Ehitajate St, 5, 19086 Tallinn, Estonia. margus.viigimaa@regionaalhaigla.ee
Helena Vaverkova
Michel Farnier
Maurizio Averna
Luc Missault
Mary E Hanson
Qian Dong
Arvind Shah
Philippe Brudi
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAzienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo · ITAZ Sint-Jan · BETallinn University of Technology · EEUniversity Hospital Olomouc · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis post-hoc analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization.

methodsPatients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n=618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n=369, high potency n=249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustments were made.

resultsSignificant treatment-by-subgroup interaction occurred for LDL-C (p=0.013), total cholesterol (p=0.025), non-HDL-C (p=0.032), and apolipoprotein B (p=0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum. Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.

conclusionsCompared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.

trial registrationRegistered at ClinicalTrials.gov: NCT00479713.

Indexed as

AdolescentAdultAgedAged, 80 and overAnticholesteremic AgentsAzetidinesEzetimibeFemaleFluorobenzenesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedPyrimidinesRosuvastatin CalciumAnticholesteremic AgentsAzetidinesEzetimibeFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsPyrimidinesRosuvastatin CalciumSimvastatinSulfonamides

Identifiers

PMID21050476
PMCPMC2992529
OpenAlexW1966123543

What Socratic holds

Textmetadata
LicenceCC BY
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.